Miles Hutchinson

How to Design and Implement Outstanding KPI Performance Dash

Grab a cup of coffee and join us to learn how to improve your KPI focus, and juice up virtually every facet of your organization's operations from marketing, to finance, to HR, to customer service and sales. Ensure your Performance Dashboards are crisp, attention grabbing and clearly identify significant performance trends. Know whether your business is meeting or exceeding its goals with your early warning system of leading and trailing performance indicators.

Speaker: Miles Hutchinson | View Anytime | Duration: 90 Minutes | Price: $149.00 | View Details
Gina Reo

Developing an Environmental Monitoring Program Satisfying FDA's Listeria Monocytogenes

FSMA (Food Safety Modernization Act) requires organizations to assess risks, enact Preventative Controls to mitigate these risks and minimize Food Safety Hazards for consumers.

Speaker: Gina Reo | View Anytime | Duration: 60 Minutes | Price: $599.00 | View Details
Robert A. (Bob) LaRosa

Hazardous Material Release Reporting Requirements

Hazardous materials pose a danger to the environment. Federal regulations require immediate reporting to specific agencies (federal and local) in the event of a release to the environment.

Speaker: Robert A. (Bob) LaRosa | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Robert A. (Bob) LaRosa

Personal Protective Equipment Requirements

Personal protective equipment, commonly referred to as "PPE", is equipment worn to minimize exposure to hazards that cause serious workplace injuries and illnesses.

Speaker: Robert A. (Bob) LaRosa | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Robert A. (Bob) LaRosa

Spill Prevention Control and Countermeasures (SPCC) Inspection Requirements

The inspection requirements of the SPCC rule are designed to detect oil leaks, spills, or other potential integrity or structural issues before they can result in a discharge of oil to navigable waters of the U.S. or adjoining shorelines.

Speaker: Robert A. (Bob) LaRosa | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Greg Martin

Understanding and Applying ICH Q3A and Q3B for Control of Impurities in Drug Substances and Drug Products

This course is designed to provide participants with an understanding of the regulatory expectations for controlling impurities and degradants (including DNA reactive/potential genotoxic impurities) in drug substances and drug products. There will be ample opportunity to discuss questions and challenges from the participants.

Speaker: Greg Martin | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Dr. Ludwig Huber

Validation and Use of Excel Spreadsheets in FDA Regulated Environments

Excel® Applications are widely used in laboratories, offices and manufacturing e.g., for data capture, data manipulation and report generation.

Speaker: Dr. Ludwig Huber | View Anytime | Duration: 75 Minutes | Price: $190.00 | View Details
Steven Wachs

Useful Statistical Methods for Defining Product and Process Specifications

Scientists, Design Engineers, and Manufacturing/Process Engineers must develop product and process specifications that ensure that products delivered to customers perform their intended functions over time.

Speaker: Steven Wachs | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Dennis Taylor

Mastering Excel Pivot Tables

PivotTable capabilities are enormous; among its many tools and features.

Speaker: Dennis Taylor | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Charles H. Paul

Preventing Human Error in the Life Sciences

This webinar will explore the true causes and nature of human error, how human error should be investigated, how human error relates to human performance, and the difference between real human error and systems, process, and management deficiencies.

Speaker: Charles H. Paul | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Susanne Manz

Secrets to Writing Effective SOPs for Medical Device QMS

Standard Operating Procedures (SOPs) are a critical ingredient in an effective and efficient Quality Management System. SOPs are typically one of the first things an investigator asks for in an inspection.

Speaker: Susanne Manz | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
John E Lincoln

Design History Files (DHF), Device Master Records (DMR), Device History Records (DHR), Technical Documentation Files - The US FDA and EU MDR Requirements

It will also consider the European Union's MDR Technical Documentation requirements, and evaluate the documents' differing purposes / goals, as well as the two different device classification schemes. Required and desirable contents will be discussed.

Speaker: John E Lincoln | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Robert A. (Bob) LaRosa

Laboratory Safety Requirements

The Occupational Exposure to Hazardous Chemicals in Laboratories standard (29 CFR 1910.1450), commonly referred to as the Laboratory standard, requires that the employer designate a Chemical Hygiene Officer and have a written Chemical Hygiene Plan (CHP), and actively verify that it remains effective.

Speaker: Robert A. (Bob) LaRosa | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Michael Esposito

2- Hour Virtual Seminar on SOP Writing, Training and Compliance in the Pharmaceutical Industry

Standard Operating Procedures (SOPs) are the basis for a large part of the day-to-day training that most pharmaceutical employees are required to perform.

Speaker: Michael Esposito | View Anytime | Duration: 2 Hours | Price: $240.00 | View Details
Michael Esposito

Onboarding Employees in a GMP Environment: Best Practices for Foundational Employee Success

The FDA's expectations for training new employees are summed up in 21 CFR 211.25(a), i.e., pharmaceutical professionals require the education, training and experience to complete their job functions.

Speaker: Michael Esposito | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Ginette Collazo

The Human Error Tool Box: A Practical Approach to Human Error

Human error is known to be the primary cause of quality and production losses in many industries. Although it is unlikely that human error will ever be eliminated, many human performance problems can be prevented. Human errors start at the design stage.

Speaker: Ginette Collazo | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Roger Cowan

Sterile Filtration of Pharmaceutical Products -What you need to know to meet Validation and Regulatory Requirements

It is important that the sterile filtration process is fully understood and properly validated for your particular application.

Speaker: Roger Cowan | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Robert J. Russell

EU Medical Device Regulation (MDR) - Updated CE Marking Process & ISO 13485:2016 Expectations

This EU Medical Device Regulation (MDR) 90-minute webinar will discuss the recently developed regulation and its impact on the future compliance and registration of medical devices in the EU.

Speaker: Robert J. Russell | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Robert J. Russell

Latin America Regulatory Compliance: Current Challenges in Argentina, Brazil and Mexico

The Latin America Regulatory compliance requirement training/webinar will cover topics across the full Life-Cycle of Company & Product licensing in the key markets of Latin America.

Speaker: Robert J. Russell | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Robert J. Russell

Drug Master Files: Understanding and Meeting your Regulatory and Processing Responsibilities

This combined Quality Agreement and DMF (Drug Master Files) training will discuss the advantages for suppliers and drug product manufacturers developing these arrangements together.

Speaker: Robert J. Russell | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Steven Wachs

Using Statistics to Determine Sample Size

We often sample from a process or population in order to make an inference about the process based on the sample results. Selecting appropriate sample sizes often vexes many practitioners.

Speaker: Steven Wachs | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Dennis Taylor

2-Hour Virtual Seminar on Mastering Excel Pivot Tables

You will learn the following in this webinar, The quickest and best ways to create PivotTables and Pivot Charts, including these capabilities: The following subjects will be covered in detail:

Speaker: Dennis Taylor | View Anytime | Duration: 2 Hours | Price: $240.00 | View Details
Martin K. Behr, III

INCOTERMS 2020 Made Easy - Decoding your Shipment

The term, Incoterms®, is an abbreviation for International Commercial Terms.

Speaker: Martin K. Behr, III | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Miles Hutchinson

1099 and W-9 Update - Complying with IRS Information Reporting

For years the IRS has struggled with the independent contractor and tax collection.

Speaker: Miles Hutchinson | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
John E Lincoln

Design History Files (DHF), Device Master Records (DMR), Device History Records (DHR), Technical Documentation Files - The US FDA and EU MDR Requirements

It will also consider the European Union's MDR Technical Documentation requirements, and evaluate the documents' differing purposes / goals, as well as the two different device classification schemes. Required and desirable contents will be discussed.

Speaker: John E Lincoln | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
John C. Fetzer

Analytical Method Validation Under Good Laboratory Practices - GLPs

If you do any work that will be reported to the US Food and Drug Administration (FDA), Environmental Protection Agency (EPA), or Occupational Safety and Health Administration (OSHA), your work must be done under GLP.

Speaker: John C. Fetzer | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Gwendolyn Wise-Blackman

Validation Challenges for Bioassays

Validation of test methods is a critical requirement for the drug development process. Bioassays are used to support biologics in the drug development process and in post-market analytical support.

Speaker: Gwendolyn Wise-Blackman | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
John Ryan

NEW FDA Proposed FSMA Rule on Food Traceability

This 60-minute webinar will cover the proposed FDA traceability requirements and techniques useful in the event of quality deviation investigations and potential FDA Recalls.

Speaker: John Ryan | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Dennis Taylor

Mastering Excel Pivot Tables

PivotTable capabilities are enormous; among its many tools and features.

Speaker: Dennis Taylor | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Ginette Collazo

How to write SOP's that Avoid Human Error

This training program will address the common human errors and deviations related to the use of procedures. It will also offer best practices for writing SOP’s to reduce the likelihood of human errors.

Speaker: Ginette Collazo | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Ginette Collazo

Human Error Reduction Techniques for Floor Supervisors

Supervision plays a crucial role in Human Error Reduction and Control. Critical Factors like preparation, planning, scheduling, communication, among many others, will be discussed as part of this webinar.

Speaker: Ginette Collazo | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Charles H. Paul

Preventing Human Error in the Life Sciences

This webinar will explore the true causes and nature of human error, how human error should be investigated, how human error relates to human performance, and the difference between real human error and systems, process, and management deficiencies.

Speaker: Charles H. Paul | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Casper Uldriks

Responsibility for Off-label Claims in Social Media

FDA's sweeping definition of labeling includes what is said or represented, even by images, in a social media platform.

Speaker: Casper Uldriks | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Susanne Manz

Death By CAPA - Does your CAPA Program Need a CAPA?

CAPA is the foundation of an effective Quality Management System. Yet, many companies suffer from Death by CAPA - a slow, bureaucratic, ineffective CAPA process.

Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Susanne Manz

3-Hour Virtual Seminar on Design Controls for Medical Devices

Design Control is considered a critical process by the FDA. Yet is still a common source of 483 and Warning Letter observations. Most importantly, Design Control is critical to product quality, ensuring safe and effective products for your customers.

Speaker: Susanne Manz | View Anytime | Duration: 3 Hours | Price: $340.00 | View Details
Susanne Manz

Secrets to Writing Effective SOPs for Medical Device QMS

Standard Operating Procedures (SOPs) are a critical ingredient in an effective and efficient Quality Management System. SOPs are typically one of the first things an investigator asks for in an inspection.

Speaker: Susanne Manz | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Susanne Manz

3-Hour Virtual Seminar on CAPA for Medical Devices

CAPA is the foundation of an effective Quality Management System. Yet, many companies suffer from Death by CAPA - a slow, bureaucratic, and ineffective CAPA process. Not only do they fail to achieve necessary improvements, they waste precious time and resources.

Speaker: Susanne Manz | View Anytime | Duration: 3 Hours | Price: $340.00 | View Details
Susanne Manz

Death by CAPA - Does your Company have the Symptoms?

CAPA is the foundation of an effective Quality Management System. Yet, many companies suffer from a slow, bureaucratic, ineffective CAPA process.

Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Michael Esposito

Onboarding Employees in a GMP Environment: Best Practices for Foundational Employee Success

The FDA's expectations for training new employees are summed up in 21 CFR 211.25(a), i.e., pharmaceutical professionals require the education, training and experience to complete their job functions.

Speaker: Michael Esposito | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
John E Lincoln

Root Cause Analysis - Starting at the Beginning

CAPA and the related actions of Failure Investigation and Root Cause Analysis (RCA) is a major tool in product complaint, non-conformance, and OOS failure investigations, and hazard analysis / risk management and mitigation activities.

Speaker: John E Lincoln | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
John E Lincoln

Verification vs Validation-Product, Process or Equipment and QMS Software

The verification and validation of regulated software is coming under increased scruinty by the U.S. FDA.

Speaker: John E Lincoln | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
John E Lincoln

Design History Files (DHF), Device Master Records (DMR), Device History Records (DHR), Technical Documentation Files - The US FDA and EU MDR Requirements

It will also consider the European Union's MDR Technical Documentation requirements, and evaluate the documents' differing purposes / goals, as well as the two different device classification schemes. Required and desirable contents will be discussed.

Speaker: John E Lincoln | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Steven Wachs

Useful Statistical Methods for Defining Product and Process Specifications

Scientists, Design Engineers, and Manufacturing/Process Engineers must develop product and process specifications that ensure that products delivered to customers perform their intended functions over time.

Speaker: Steven Wachs | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Steven Wachs

Sample Size Determination for Design Validation Activities

Design Validation should ensure that product performance, quality, and reliability requirements are met.

Speaker: Steven Wachs | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Steven Wachs

Determining Sample Size: What Sample Size Should I Use?

The webinar will provide important considerations when selecting sample sizes for specific applications.

Speaker: Steven Wachs | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Brenda Neckvatal

The Coronavirus in the Workplace

The circumstances surrounding the coronavirus are continuing to develop each day, and with the rapid-fire nature of the modern media, details vary from broadcast to broadcast, leaving the audience in fear and confused as to what next steps they should take. Having a plan is the best course of action, and with the changing national condition, employers are feeling the pressure of growing concern.

Speaker: Brenda Neckvatal | View Anytime | Duration: 60 Minutes | Price: $195.00 | View Details
Martin K. Behr, III

Importing and Exporting Covid-19 Products

The outbreak of coronavirus disease (COVID-19), first in the People's Republic of China (PRC or China), and now globally, including in the United States, is drawing attention to the ways in which the United States and other economies depend on critical manufacturing and global value chains that rely on production based in in the PRC and other countries.

Speaker: Martin K. Behr, III | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Martin K. Behr, III

INCOTERMS 2020 Made Easy - Decoding your Shipment

The term, Incoterms®, is an abbreviation for International Commercial Terms.

Speaker: Martin K. Behr, III | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Mike Thomas

Power BI - Calculations and Measures

This session follows on from "Power BI - Getting Started" and focuses on creating reports from multiple data sources, cleaning and transforming your data and creating Calculated Columns and Measures.

Speaker: Mike Thomas | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Karla Brandau

Outlook Tips and Techniques Survive an Avalanche of Emails

Is managing your Inbox and digging out from an avalanche of emails a full time job? Then sign up for this webinar and learn how to survive the heavy load of tasks and the constant stream of trivia that arrives via email.

Speaker: Karla Brandau | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Steven Wachs

Using Statistics to Determine Sample Size

We often sample from a process or population in order to make an inference about the process based on the sample results. Selecting appropriate sample sizes often vexes many practitioners.

Speaker: Steven Wachs | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
John C. Fetzer

Analytical Method Validation Under Good Laboratory Practices - GLPs

If you do any work that will be reported to the US Food and Drug Administration (FDA), Environmental Protection Agency (EPA), or Occupational Safety and Health Administration (OSHA), your work must be done under GLP.

Speaker: John C. Fetzer | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Dennis Taylor

Mastering Excel Pivot Tables

PivotTable capabilities are enormous; among its many tools and features.

Speaker: Dennis Taylor | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Dennis Taylor

2-Hour Virtual Seminar on Mastering Excel Pivot Tables

You will learn the following in this webinar, The quickest and best ways to create PivotTables and Pivot Charts, including these capabilities: The following subjects will be covered in detail:

Speaker: Dennis Taylor | View Anytime | Duration: 2 Hours | Price: $240.00 | View Details
Mike Thomas

Excel - Formulas and Functions 101

Although it is perfectly possible to use Excel without ever creating a formula or using a function if you don't, you're missing out on a huge part of the application's power.

Speaker: Mike Thomas | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Teri C. Soli

Water System Mythology: Common False Beliefs for Microbial Control and Monitoring

It is an unfortunate fact that most water systems today have been designed and are operated and controlled using at least some traditional concepts and methods that are downright wrong. So how could such traditions become so ingrained and be so wrong? How could well-intentioned benchmarking be so misguided?

Speaker: Teri C. Soli | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Tom Fragale

Excel PowerPivot and Power Query

If you work with data, you're likely already familiar with common frustrations with Microsoft Excel like size limitations and manually entering data from multiple sources.

Speaker: Tom Fragale | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
David Ringstrom

Master Excel: Excel Dashboards

In this informative webcast, Excel expert David H. Ringstrom, CPA, introduces you to the concept of Microsoft Excel dashboards.

Speaker: David Ringstrom | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Robert J. Russell

Drug Master Files: Understanding and Meeting your Regulatory and Processing Responsibilities

This combined Quality Agreement and DMF (Drug Master Files) training will discuss the advantages for suppliers and drug product manufacturers developing these arrangements together.

Speaker: Robert J. Russell | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Robert J. Russell

BREXIT - What's Changing for Life Science Product License Holders-Manufacturers and What you Need to do Right Now

The United Kingdom submitted its' notification on 29 March 2017 to withdraw from the European Union.

Speaker: Robert J. Russell | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Jeff Kasoff

How FDA Trains its Investigators to Review CAPA and What you Should do to Prepare

Year after year, CAPA is the subsystem cited most frequently during FDA inspections. During an inspection, FDA personnel will take a great deal of time reviewing your company's CAPA system. What will they look for? This session will discuss techniques used by the FDA to review your CAPA system. The documents used by FDA to train their inspectors to review your CAPA system will be explained, some of which you may not be familiar with.

Speaker: Jeff Kasoff | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Casper Uldriks

3-Hour Virtual Seminar on FDA's Scrutiny of Social Media Promotion

FDA steadily expands the scope and restrictions for promotion of products under its jurisdiction. Whatever and where ever to want to talk about your product, just assume your talking to FDA.

Speaker: Casper Uldriks | View Anytime | Duration: 3 Hours | Price: $340.00 | View Details
Jeff Kasoff

FDA Inspections - Do's and Don'ts

Does the FDA call in advance or just show up at my door? Where do I let the inspector go? Do I give them a tour? What should I let them see? Who should I let them talk to? Are they ever going to leave?

Speaker: Jeff Kasoff | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Casper Uldriks

Responsibility for Off-label Claims in Social Media

FDA's sweeping definition of labeling includes what is said or represented, even by images, in a social media platform.

Speaker: Casper Uldriks | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Robert J. Russell

Latin America Regulatory Compliance: Current Challenges in Argentina, Brazil and Mexico

The Latin America Regulatory compliance requirement training/webinar will cover topics across the full Life-Cycle of Company & Product licensing in the key markets of Latin America.

Speaker: Robert J. Russell | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Tom Fragale

Mastering Excel Pivot Tables & Pivot Charts: Number Crunching Made Easy

In this webinar, you will learn how to take all of your raw data and quickly turn that data into easy to use flexible summary reports using Pivot Tables and Charts. We will start with the basics and built up to more complex pivot tables.

Speaker: Tom Fragale | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Casper Uldriks

FDA's New Import Program for 2020 and Impact of the COVID-19

In this interactive session author will discuss the impact of the COVID-19 and the FDA's required information for the PREDICT software screening prior to entry and Custom's Harmonized Tariff Schedule (HTS).

Speaker: Casper Uldriks | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Michael Esposito

Onboarding Employees in a GMP Environment: Best Practices for Foundational Employee Success

The FDA’s expectations for training new employees are summed up in 21 CFR 211.25(a), i.e., pharmaceutical professionals require the education, training and experience to complete their job functions.

Speaker: Michael Esposito | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Michael Esposito

Good Manufacturing Practices (GMP) - An Introduction

Good Manufacturing Practices (GMP) describe the requirements for manufacturing drug product in a given country or region and cover areas such as facility design and sanitation, product testing, product identification, equipment, packaging, warehousing and distribution, and recordkeeping.

Speaker: Michael Esposito | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Susanne Manz

Essentials of Validation - IQ, OQ, PQ

Validation is an important element of the Quality System Regulations and ISO13485.

Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Susanne Manz

Writing Excellent SOPs

Almost every paragraph of the Quality System Regulation states that manufacturers shall "establish" procedures.

Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Edwin Waldbusser

FDA Regulation of Artificial Intelligence/ Machine Learning

AI/ ML will revolutionize medicine by making diagnosis and treatment more accessible and more effective.

Speaker: Edwin Waldbusser | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Yuval Shapiro

Risk Management - Implementing ISO14971: 2019

Mr. Shapiro shall present the basic principles and practices of Risk Management Approach and Risk Analysis. Presentation best practice tools to manage risk analysis and risk management.

Speaker: Yuval Shapiro | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Carolyn Troiano

Computer System Validation (CSV) for FDA-Regulated Computers

The Webinar will focus on the importance of ensuring that the validation of an FDA-regulated computer system will meet compliance guidelines.

Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Dennis Taylor

2-Hour Virtual Seminar on Mastering Excel Pivot Tables

You will learn the following in this webinar, The quickest and best ways to create PivotTables and Pivot Charts, including these capabilities: The following subjects will be covered in detail:

Speaker: Dennis Taylor | View Anytime | Duration: 2 Hours | Price: $240.00 | View Details
Dennis Taylor

Mastering Excel Pivot Tables

PivotTable capabilities are enormous; among its many tools and features.

Speaker: Dennis Taylor | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Yuval Shapiro

Cost of Quality from Theory to Implementation

How could one assess the effectiveness of a Quality Management System? The best way to do that, is by using the ultimate transfer unit: MONEY!

Speaker: Yuval Shapiro | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Yuval Shapiro

Creating Optimal Sampling Plans

A sampling plan is a term widely used in research studies that provide an outline on the basis which of research is conducted. It tells which category is to be surveyed, what should be the sample size and how the respondents should be chosen out of the population.

Speaker: Yuval Shapiro | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Gwendolyn Wise-Blackman

Validation Challenges for Bioassays

Validation of test methods is a critical requirement for the drug development process. Bioassays are used to support biologics in the drug development process and in post-market analytical support.

Speaker: Gwendolyn Wise-Blackman | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Eleonora Babayants

FDA Compliance for Mobile Applications

Attend this webinar to understand the FDA guidance for mobile applications.

Speaker: Eleonora Babayants | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Danielle DeLucy

Handling OOS Test Results and Completing Robust Investigations

This webinar will review the regulatory requirements for investigating an OOS Investigation. The responsibilities of the analyst, the supervisor and QA will be discussed.

Speaker: Danielle DeLucy | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Danielle DeLucy

Best Practices for Deviation Investigations

This webinar will help attendees understand the fundamental steps of a deviation investigation with focus on using facts and objective evidence to arrive at root cause and CAPA.

Speaker: Danielle DeLucy | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Martin K. Behr, III

Say Goodbye to NAFTA: The USMCA is Now Here

The North America Free Trade Agreement (NAFTA) comprises Canada, the U.S. and Mexico, an agreement which has eliminated barriers to trade, promoted conditions of fair competition, increased investment opportunities, provided protection for intellectual property rights, and established procedures for the resolution of disputes.

Speaker: Martin K. Behr, III | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Edwin Waldbusser

21 CFR Part 11 - Compliance for Electronic Records and Signatures

This Webinar will explain what 21 CFR Part 11 is, why it is important to FDA regulated companies and how conformance to Part 11 differs from just having good IT security.

Speaker: Edwin Waldbusser | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Edwin Waldbusser

Medical Device Risk Management following ISO 14971:2019

The US FDA expects that as part of a product development Design Control Program risk management will be conducted. FDA also expects that a post production risk management program be implemented.

Speaker: Edwin Waldbusser | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
John C. Fetzer

HPLC Analytical Method Development and Validation

Instrumental liquid chromatography is an analysis are widely used to determine purity, the impurities, and the degradation products of pharmaceuticals.

Speaker: John C. Fetzer | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
John C. Fetzer

Analytical Method Validation Under Good Laboratory Practices - GLPs

If you do any work that will be reported to the US Food and Drug Administration (FDA), Environmental Protection Agency (EPA), or Occupational Safety and Health Administration (OSHA), your work must be done under GLP.

Speaker: John C. Fetzer | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Steven Wachs

Determining Sample Size: What Sample Size Should I Use?

The webinar will provide important considerations when selecting sample sizes for specific applications.

Speaker: Steven Wachs | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Steven Wachs

Sample Size Determination for Design Validation Activities

Design Validation should ensure that product performance, quality, and reliability requirements are met.

Speaker: Steven Wachs | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Steven Wachs

Useful Statistical Methods for Defining Product and Process Specifications

Scientists, Design Engineers, and Manufacturing/Process Engineers must develop product and process specifications that ensure that products delivered to customers perform their intended functions over time.

Speaker: Steven Wachs | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Steven Wachs

Using Statistics to Determine Sample Size

We often sample from a process or population in order to make an inference about the process based on the sample results. Selecting appropriate sample sizes often vexes many practitioners.

Speaker: Steven Wachs | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
John E Lincoln

Design History Files (DHF), Device Master Records (DMR), Device History Records (DHR), Technical Documentation Files - The US FDA and EU MDR Requirements

It will also consider the European Union's MDR Technical Documentation requirements, and evaluate the documents' differing purposes / goals, as well as the two different device classification schemes. Required and desirable contents will be discussed.

Speaker: John E Lincoln | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
John E Lincoln

Verification vs Validation-Product, Process or Equipment and QMS Software

The verification and validation of regulated software is coming under increased scruinty by the U.S. FDA.

Speaker: John E Lincoln | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
John E Lincoln

Dietary Supplements CGMPS - 21 CFR 111 Compliance

21 CFR part 111 ("the DS CGMP rule") requires persons who manufacture, package, label, or hold a dietary supplement to establish and follow current good manufacturing practice-the CGMPs.

Speaker: John E Lincoln | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Yuval Shapiro

Risk Management - Implementing ISO14971: 2019

Mr. Shapiro shall present the basic principles and practices of Risk Management Approach and Risk Analysis. Presentation best practice tools to manage risk analysis and risk management.

Speaker: Yuval Shapiro | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Yuval Shapiro

ISO13485: 2016 - Quality Management Systems for Medical Devices

This webinar presents to the participants the new requirements of the standard and how they correlate with the regulatory changes in the EU.

Speaker: Yuval Shapiro | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Charles H. Paul

3-Hour Virtual Seminar on Project Management for Non-Project Managers

This webinar will address those project management critical tasks within each project phase that must be performed flawlessly for effective project execution to occur and will provide the foundation and direction for future study of the subject.

Speaker: Charles H. Paul | View Anytime | Duration: 3 Hours | Price: $340.00 | View Details
Charles H. Paul

Project Management for Non-Project Managers

This webinar will address those project management critical tasks within each project phase that must be performed flawlessly for effective project execution to occur and will provide the foundation and direction for future study of the subject.

Speaker: Charles H. Paul | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Dennis Taylor

Mastering Excel Pivot Tables

PivotTable capabilities are enormous; among its many tools and features.

Speaker: Dennis Taylor | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Edwin Waldbusser

How to Conduct a Human Factors/ Usability Validation

This webinar will explain the procedure described in ISO62366 and the 2016 FDA Guidance for a compliant human factors/ usability validation. HF/U validation is very different from device validation.

Speaker: Edwin Waldbusser | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Edwin Waldbusser

Human Factors/ Usability Studies following ISO62366 and the new FDA Guidance

Human Factors/ Usability is the analysis of how people interact with medical devices.

Speaker: Edwin Waldbusser | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Edwin Waldbusser

Medical Device Hazard analysis following ISO 14971

The US FDA expects that as part of a product development Design Control Program risk management will be conducted. FDA also expects a post production risk management program be implemented.

Speaker: Edwin Waldbusser | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Edwin Waldbusser

Medical Device Risk Management following ISO 14971:2019

The US FDA expects that as part of a product development Design Control Program risk management will be conducted. FDA also expects that a post production risk management program be implemented.

Speaker: Edwin Waldbusser | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Thomas E. Colonna

Introduction to Biomedical Software Regulation

The Food and Drug Administration (FDA) was not empowered by Congress to regulate medical devices until May 28, 1976 when the Medical Device Amendments were added to the Federal Food, Drug, and Cosmetic Act (FDCA).

Speaker: Thomas E. Colonna | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Roger Cowan

Sterile Filtration of Pharmaceutical Products -What you need to know to meet Validation and Regulatory Requirements

It is important that the sterile filtration process is fully understood and properly validated for your particular application.

Speaker: Roger Cowan | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Robert J. Russell

Drug Master Files: Understanding and Meeting your Regulatory Responsibilities

This combined DMF (Drug Master Files) and Quality Agreement training will discuss the advantages for suppliers and drug product manufacturers in developing these arrangements together.

Speaker: Robert J. Russell | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Ginette Collazo

Human Error Reduction Techniques for Floor Supervisors

Supervision plays a crucial role in Human Error Reduction and Control. Critical Factors like preparation, planning, scheduling, communication, among many others, will be discussed as part of this webinar.

Speaker: Ginette Collazo | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Ginette Collazo

The Human Error Tool Box: A Practical Approach to Human Error

Human error is known to be the primary cause of quality and production losses in many industries. Although it is unlikely that human error will ever be eliminated, many human performance problems can be prevented. Human errors start at the design stage.

Speaker: Ginette Collazo | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Vicki M. Lambert

Corona Virus 2020 Payroll Update: What the Payroll Department Must Know

The global pandemic is here and has caused us to change and adapt our working and personal lives.

Speaker: Vicki M. Lambert | View Anytime | Duration: 90 Minutes | Price: $195.00 | View Details
Karla Brandau

Unmanageable Inbox? Imagine a Clean Inbox and Take Control Today!

Do you remember when hand-written letters or typed letters was the main means of communication? If so, you may also remember how glorious it was to send information and have immediately received via the fax machine.

Speaker: Karla Brandau | View Anytime | Duration: 60 Minutes | Price: $195.00 | View Details
Diane L. Dee

COVID-19 U.S. Employment Law Update and Guidance for Employers

In a rare show of bipartisanship, the Families First Coronavirus Response Act (FFCRA) was signed into law on March 18, 2020.

Speaker: Diane L. Dee | View Anytime | Duration: 90 Minutes | Price: $195.00 | View Details
Rhonda Scharf CSP - HoF

Managing Interruptions - The Art of Getting Work Done

According to Jonathan Spira, interruptions cost the US economy almost $1 trillion annually, and eat up to 28 billion hours each year.

Speaker: Rhonda Scharf CSP - HoF | View Anytime | Duration: 60 Minutes | Price: $195.00 | View Details
Teri Morning

Workplace Investigations - Witnesses Interviews

Many employers struggle to gather information during witness interviews in investigations. Many employees for a variety of reasons are reluctant to be involved and can be less than forthcoming.

Speaker: Teri Morning | View Anytime | Duration: 90 Minutes | Price: $195.00 | View Details
Dr. Susan Strauss

2-Hour Virtual Seminar on Workplace Investigations 101: How to Conduct your Investigation Like a Pro

When we think of workplace investigations, the most common thought is that of investigating harassment complaints.

Speaker: Dr. Susan Strauss | View Anytime | Duration: 2 Hours | Price: $235.00 | View Details
Rhonda Scharf CSP - HoF

Dealing with Difficult People

Sounds pretty simple, doesn't it? When you do it right, Dealing With Difficult People drastically improves your life as you improve your working relationships with people who challenge you to the limits of your patience (yes, even the ones who make you tear your hair out - literally!).

Speaker: Rhonda Scharf CSP - HoF | View Anytime | Duration: 60 Minutes | Price: $195.00 | View Details
Beverly Beuermann-King

Stop Letting that Difficult Person Ruin your Day-Effectively Handle Toxic People for Better Productivity and Less Drama

Negative and difficult people are toxic and can ruin our day. Learn successful strategies and tips for building a positive, productive workplace by knowing WHAT to focus on to move the conversation forward, HOW to effectively respond, and WAYS to manage the impact of their behaviour.

Speaker: Beverly Beuermann-King | View Anytime | Duration: 60 Minutes | Price: $195.00 | View Details
Bob Verchota

Toolkit for Conducting Exit Interviews

This webinar will give you all the tools you need to start your Exit Interview program or improve the one you have. It isn't rocket science but there are best practices and considerations for doing them well. Our intent is to get you up to speed as quickly and effectively as possible.

Speaker: Bob Verchota | View Anytime | Duration: 60 Minutes | Price: $195.00 | View Details
Brenda Neckvatal

Updated: Employers Playbook for the Families First Coronavirus Act

The new Families First Coronavirus Response Act takes effect April 2, 2020 and with it comes temporary requirements that impacts employers with less than 500 employees.

Speaker: Brenda Neckvatal | View Anytime | Duration: 90 Minutes | Price: $195.00 | View Details
Brenda Neckvatal

COVID-19: Preparing for a Reduction in Your Workforce

The circumstances surrounding the Coronavirus (COVID-19) are continuing to develop hourly (let alone daily), and with the rapid-fire nature of modern media and social media channels, details vary from broadcast to broadcast, leaving many in the workforce in confusion and fear.

Speaker: Brenda Neckvatal | View Anytime | Duration: 90 Minutes | Price: $195.00 | View Details
Michael D. Haberman

Onboarding is NOT Orientation - How to Improve the New Employee Experience

In this webinar we will learn the reasons onboarding is important today. We will learn that the terms orientation and onboarding are not interchangeable. We will learn that orientation is in reality just one step in the onboarding process. We will learn that the onboarding process begins before the hire is made.

Speaker: Michael D. Haberman | View Anytime | Duration: 60 Minutes | Price: $195.00 | View Details
Brenda Neckvatal

Managing a Remote Workforce Through the Coronavirus Pandemic

The circumstances surrounding the Coronavirus (COVID-19) are continuing to develop hourly (let alone daily), and with the rapid-fire nature of modern media and social media channels, details vary from broadcast to broadcast, leaving many in the workforce in confusion and fear.

Speaker: Brenda Neckvatal | View Anytime | Duration: 90 Minutes | Price: $195.00 | View Details
Karla Brandau

Learn to Sort, Prioritize and Get Work done Right in your Inbox

Prioritizing is a fundamental time management principle and, in this webinar, you are taught the principles of prioritizing and how to work check off work right in your Inbox.

Speaker: Karla Brandau | View Anytime | Duration: 60 Minutes | Price: $195.00 | View Details
Dr. B. Lynn Ware

Best Practices for Implementing Employee Engagement Surveys

Improving employee engagement can have dramatic effects on the organization's bottom line. Engaged employees are significantly more productive and less likely to leave.

Speaker: Dr. B. Lynn Ware | View Anytime | Duration: 60 Minutes | Price: $195.00 | View Details
Dr. B. Lynn Ware

Successfully Manage Employees who Work from Home

Though there has been a recent trend toward employers offering remote working and telecommuting arrangements, having a majority of your workforce working from home can be daunting when leaders and managers have firm deliverables and deadlines to meet.

Speaker: Dr. B. Lynn Ware | View Anytime | Duration: 60 Minutes | Price: $195.00 | View Details
John N. Zorich

Better Alternatives to AQL Sampling Plans for Risk Management in Incoming QC

The pros and cons of the 2 most widely used sampling plans (ANSI Z1.4, and Squeglia's C=0) are examined in detail, focusing especially on the weaknesses of such plans in regards to meeting regulatory requirements.

Speaker: John N. Zorich | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
John N. Zorich

Valid Statistical Rationales for Sample Sizes

This webinar explains the logic behind sample-size choice for several statistical methods that are commonly used in verification or validation efforts, and how to express a valid statistical justification for a chosen sample size.

Speaker: John N. Zorich | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
John N. Zorich

Process Validation: Statistical Justification for Sample Size and the Use of Only 3 Lots

This webinar explains how to choose and justify a sample-size for Lots that are included in Process Validation studies.

Speaker: John N. Zorich | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Brenda Neckvatal

Employers Playbook for the Families First Coronavirus Act

The new Families First Coronavirus Response Act takes effect April 2, 2020 and with it comes temporary requirements that impacts employers with less than 500 employees.

Speaker: Brenda Neckvatal | View Anytime | Duration: 90 Minutes | Price: $195.00 | View Details
Angela Bazigos

Regulatory Challenges of Real-world Artificial Intelligence (AI) and Machine Learning (ML)

This session will provide insights on moving from the traditional regulatory strategies for mature technologies to the new regulatory strategies for novel uses of AI and ML while engaging FDA and/or Notified Bodies in the effort. The IMDRF, US and EU perspectives on what's next for AI and ML as SaMD will be explored.

Speaker: Angela Bazigos | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Angela Bazigos

3-Hour Virtual Seminar on Project Management for Computer Systems Validation

Project Management is defined as the planning and organization of an organization's resources in order to move a specific task, event or duty toward completion.

Speaker: Angela Bazigos | View Anytime | Duration: 3 Hours | Price: $340.00 | View Details
Dr. B. Lynn Ware

Successfully Manage Employees who Work from Home

Though there has been a recent trend toward employers offering remote working and telecommuting arrangements, having a majority of your workforce working from home can be daunting when leaders and managers have firm deliverables and deadlines to meet.

Speaker: Dr. B. Lynn Ware | View Anytime | Duration: 60 Minutes | Price: $195.00 | View Details
Brenda Neckvatal

The Arrival of Coronavirus in the Workplace

This is sessions provides current updates and information on the fast developing environment around the Coronavirus in the workplace.

Speaker: Brenda Neckvatal | View Anytime | Duration: 90 Minutes | Price: $195.00 | View Details
Brenda Neckvatal

The Arrival of Coronavirus in the Workplace

This is sessions provides current updates and information on the fast developing environment around the Coronavirus in the workplace.

Speaker: Brenda Neckvatal | View Anytime | Duration: 60 Minutes | Price: $195.00 | View Details
Yuval Shapiro

Risk Management - Implementing ISO14971: 2019

Mr. Shapiro shall present the basic principles and practices of Risk Management Approach and Risk Analysis. Presentation best practice tools to manage risk analysis and risk management.

Speaker: Yuval Shapiro | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Brenda Neckvatal

The Coronavirus in the Workplace

The circumstances surrounding the coronavirus are continuing to develop each day, and with the rapid-fire nature of the modern media, details vary from broadcast to broadcast, leaving the audience in fear and confused as to what next steps they should take.

Speaker: Brenda Neckvatal | View Anytime | Duration: 60 Minutes | Price: $195.00 | View Details
Ginette Collazo

How to write SOP's that Avoid Human Error

This training program will address the common human errors and deviations related to the use of procedures. It will also offer best practices for writing SOP’s to reduce the likelihood of human errors.

Speaker: Ginette Collazo | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
John C. Fetzer

Validation of GC / GC-MS Methodologies

This training program will cover in detail the method validation of gas chromatography (GC) and gas chromatography mass spectrometry (GC-MS).

Speaker: John C. Fetzer | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
John C. Fetzer

Validation of HPLC/UPLC Methodologies

This training program will cover in detail the key elements of HPLC and UPLC method validation to ensure compliance with FDA GLP and ISO 17025 requirements.

Speaker: John C. Fetzer | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
John E Lincoln

Design History Files (DHF), Device Master Records (DMR), Device History Records (DHR), Technical Documentation Files - The US FDA and EU MDR Requirements

It will also consider the European Union's MDR Technical Documentation requirements, and evaluate the documents' differing purposes / goals, as well as the two different device classification schemes. Required and desirable contents will be discussed.

Speaker: John E Lincoln | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
John E Lincoln

Project Management for FDA-Regulated Companies

This webinar is not a project management certification course. It is designed to provide the non-project manager with the tools / techniques necessary to assist in achieving a result or deliverable to achieve that end, and document the activity over time.

Speaker: John E Lincoln | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Steven S. Kuwahara

GMP Expectations for Products Used in Early Phase IND Studies

FDA issued a guidance document covering GMP requirements for Phase 1 products.

Speaker: Steven S. Kuwahara | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Steve Gompertz

The 7 Habits of Highly Effective Project Managers

Too often Project Leaders and Managers fall into the role due to demonstrated technical competence.

Speaker: Steve Gompertz | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Steve Gompertz

Performing More Effective SWOT Analyses

Analyzing strengths, weaknesses, opportunities, and threats through a SWOT Analysis is a common tool for strategic planning for businesses, business units, departments, or projects.

Speaker: Steve Gompertz | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Angela Bazigos

If it Isn't Written Down, then it Didn't Happen: Complying with FDA's Good Documentation Practices

Good documentation practice (commonly abbreviated GDP, recommended to abbreviate as GDocP to distinguish from "good distribution practice" also abbreviated GDP) is a term in the pharmaceutical and medical device industries to describe standards by which documents are created and maintained.

Speaker: Angela Bazigos | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Jose Mora

Scrutinizing Test Method Validation (TMV) to Verify the Performance of a Medical Device

Test method validation is an often-confusing requirement for medical devices. A fundamental issue is the role-reversal between the test method and the product or process it is designed to detect.

Speaker: Jose Mora | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Angela Bazigos

FDA's Cloud Compliance & Regulations

This presentation will provide a baseline of information related to cloud computing which will help the attendee better understand the cloud concept, associated regulatory challenges, and suggestions for consideration when establishing a cloud based system.

Speaker: Angela Bazigos | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Susanne Manz

Writing Excellent SOPs

Almost every paragraph of the Quality System Regulation states that manufacturers shall "establish" procedures.

Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Susanne Manz

Death By CAPA - Does your CAPA Program Need a CAPA?

CAPA is the foundation of an effective Quality Management System. Yet, many companies suffer from Death by CAPA - a slow, bureaucratic, ineffective CAPA process.

Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Edwin Waldbusser

Mobile Medical Apps(is it a FDA Regulated Device) and Cybersecurity

This webinar will explain how to determine if your app is a medical device and if it will be subject to FDA requirements.

Speaker: Edwin Waldbusser | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Martin K. Behr, III

The "New NAFTA": The USMCA

The North America Free Trade Agreement (NAFTA) comprises Canada, the U.S. and Mexico, an agreement which has eliminated barriers to trade, promoted conditions of fair competition, increased investment opportunities, provided protection for intellectual property rights, and established procedures for the resolution of disputes.

Speaker: Martin K. Behr, III | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Eyal Lerner

The New ISO 13485:2016 and Comparison with 21CFR820 - How to Comply with both in the Same Organization

Many medical devices are distributed in USA and in the European Union (EU). Each market has its own regulatory requirements which mainly focused on its quality management systems (QMS).

Speaker: Eyal Lerner | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Charles H. Paul

Project Management for Non-Project Managers

This webinar will address those project management critical tasks within each project phase that must be performed flawlessly for effective project execution to occur and will provide the foundation and direction for future study of the subject.

Speaker: Charles H. Paul | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Thomas E. Colonna

FDA Regulation of Dietary Supplements

FDA regulates both finished dietary supplement products and dietary ingredients.

Speaker: Thomas E. Colonna | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Carolyn Troiano

Computer System Validation (CSV) for FDA-Regulated Computers

The Webinar will focus on the importance of ensuring that the validation of an FDA-regulated computer system will meet compliance guidelines.

Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Carolyn Troiano

Good Documentation Practices to Support FDA Computer System Validation

As a "GxP"system, following Good Manufacturing, Laboratory and Clinical Practices, the computer system must be validated in accordance with FDA requirements.

Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Casper Uldriks

Responsibility for Off-label Claims in Social Media

FDA's sweeping definition of labeling includes what is said or represented, even by images, in a social media platform.

Speaker: Casper Uldriks | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Casper Uldriks

FDA's New Import Program for 2020 and Impact of the COVID-19

In this interactive session author will discuss the impact of the COVID-19 and the FDA's required information for the PREDICT software screening prior to entry and Custom's Harmonized Tariff Schedule (HTS).

Speaker: Casper Uldriks | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Michael Esposito

Onboarding Employees in a GMP Environment: Best Practices for Foundational Employee Success

The FDA's expectations for training new employees are summed up in 21 CFR 211.25(a), i.e., pharmaceutical professionals require the education, training and experience to complete their job functions.

Speaker: Michael Esposito | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Michael Esposito

2- Hour Virtual Seminar on SOP Writing, Training and Compliance in the Pharmaceutical Industry

Standard Operating Procedures (SOPs) are the basis for a large part of the day-to-day training that most pharmaceutical employees are required to perform.

Speaker: Michael Esposito | View Anytime | Duration: 2 Hours | Price: $240.00 | View Details
Angela Bazigos

3-Hour Virtual Seminar on What do the FDA, EMA and PMDA Look for When Conducting cGMP Regulatory Inspections

It has often been stated that "FDA inspects for compliance; European inspectors inspect for adequate science".

Speaker: Angela Bazigos | View Anytime | Duration: 3 Hours | Price: $340.00 | View Details
Angela Bazigos

Electronic Records & Electronic Signatures; 21 CFR Part 11; Basic Concepts

Documented Part 11 training, as with any FDA regulation, is required for staff members who have responsibilities within the scope of the regulation.

Speaker: Angela Bazigos | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Ginette Collazo

Supervising a Human Error Free Environment: You can do a Lot More than you Think

Human error is known to be the major cause of quality and production losses in many industries.

Speaker: Ginette Collazo | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Yuval Shapiro

Risk Management - Implementing ISO14971: 2019

Mr. Shapiro shall present the basic principles and practices of Risk Management Approach and Risk Analysis. Presentation best practice tools to manage risk analysis and risk management.

Speaker: Yuval Shapiro | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Angela Bazigos

Key Factors to Write an Effective Standard Operating Procedure (SOP) and Work Instructions (WIs)

This webinar will instruct the participant on how to write, organize, and maintain SOPs and train personnel in a way that will ensure compliance in a way that is concise, reproducible and easy to follow.

Speaker: Angela Bazigos | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Angela Bazigos

Audit Trail Generation and Review

Computerized systems are used throughout the life sciences industry to support various regulated activities,which in turn generate many types of electronic records.

Speaker: Angela Bazigos | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
John N. Zorich

Metrology: Statistical Analysis of Measurement Uncertainty

The webinar begins with an examination of the fundamental vocabulary and concepts related to metrology. Topics include: accuracy, precision, calibration, and "uncertainty ratios".

Speaker: John N. Zorich | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Steve Gompertz

The 7 Habits of Highly Effective Project Managers

Too often Project Leaders and Managers fall into the role due to demonstrated technical competence.

Speaker: Steve Gompertz | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Danielle DeLucy

Best Practices for Deviation Investigations

This webinar will help attendees understand the fundamental steps of a deviation investigation with focus on using facts and objective evidence to arrive at root cause and CAPA.

Speaker: Danielle DeLucy | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Angela Bazigos

Make Your FDA Inspection as Painless as Possible

This session will discuss how to prepare for the inspection, what to do during the inspection and the close-out interview, and how to respond to the inspection.

Speaker: Angela Bazigos | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Angela Bazigos

FDA's Cloud Compliance & Regulations

This presentation will provide a baseline of information related to cloud computing which will help the attendee better understand the cloud concept, associated regulatory challenges, and suggestions for consideration when establishing a cloud based system.

Speaker: Angela Bazigos | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Angela Bazigos

If it Isn't Written Down, then it Didn't Happen: Complying with FDA's Good Documentation Practices

Good documentation practice (commonly abbreviated GDP, recommended to abbreviate as GDocP to distinguish from "good distribution practice" also abbreviated GDP) is a term in the pharmaceutical and medical device industries to describe standards by which documents are created and maintained.

Speaker: Angela Bazigos | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Susanne Manz

Secrets to Writing Effective SOPs for Medical Device QMS

Standard Operating Procedures (SOPs) are a critical ingredient in an effective and efficient Quality Management System. SOPs are typically one of the first things an investigator asks for in an inspection.

Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Ginette Collazo

3-Hour Virtual Seminar on Human Error Reduction in GMP Related Environments

Human error is known to be the primary cause of quality and production losses in many industries.

Speaker: Ginette Collazo | View Anytime | Duration: 3 Hours | Price: $340.00 | View Details
Michael Abitz

Fishbone Diagramming

Fishbone Diagramming is an analytical approach used to identify and solve problems. Analysis is presented in the Seven Basic Tools of Quality in addition to advanced methods used to increase organizations effectiveness, efficiency and reliability.

Speaker: Michael Abitz | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Steven Wachs

Using Statistics to Determine Sample Size

We often sample from a process or population in order to make an inference about the process based on the sample results. Selecting appropriate sample sizes often vexes many practitioners.

Speaker: Steven Wachs | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Steven Wachs

Sample Size Determination for Design Validation Activities

Design Validation should ensure that product performance, quality, and reliability requirements are met.

Speaker: Steven Wachs | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Steven Wachs

Useful Statistical Methods for Defining Product and Process Specifications

Scientists, Design Engineers, and Manufacturing/Process Engineers must develop product and process specifications that ensure that products delivered to customers perform their intended functions over time.

Speaker: Steven Wachs | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Dennis Taylor

Time-Saving Excel Tips, Tricks and 100 Shortcuts

Microsoft Excel has a tremendous amount of capability and features and is filled with shortcuts and methods not always visible to the casual user.

Speaker: Dennis Taylor | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Dennis Taylor

Mastering Excel Pivot Tables

PivotTable capabilities are enormous; among its many tools and features.

Speaker: Dennis Taylor | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Dennis Taylor

2-Hour Virtual Seminar on Mastering Excel Pivot Tables

You will learn the following in this webinar, The quickest and best ways to create PivotTables and Pivot Charts, including these capabilities: The following subjects will be covered in detail:

Speaker: Dennis Taylor | View Anytime | Duration: 2 Hours | Price: $240.00 | View Details
Charles H. Paul

FDA Audit Best Practices - Do's and Don'ts

This webinar will begin by discussing and emphasizing the importance of truthfulness to the process - truthfulness in performing the job on a daily basis, truthfulness in completing the regulatory documentation that is so much a part of our regulatory lives, and finally in the context of this webinar, truthfulness when interacting with FDA inspectors.

Speaker: Charles H. Paul | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Charles H. Paul

Project Management for Non-Project Managers

This webinar will address those project management critical tasks within each project phase that must be performed flawlessly for effective project execution to occur and will provide the foundation and direction for future study of the subject.

Speaker: Charles H. Paul | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Edwin Waldbusser

21 CFR Part 11 - Compliance for Electronic Records and Signatures

This Webinar will explain what 21 CFR Part 11 is, why it is important to FDA regulated companies and how conformance to Part 11 differs from just having good IT security.

Speaker: Edwin Waldbusser | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Casper Uldriks

Responsibility for Off-label Claims in Social Media

FDA's sweeping definition of labeling includes what is said or represented, even by images, in a social media platform.

Speaker: Casper Uldriks | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Casper Uldriks

FDA's New Import Program for 2020

The FDA and U.S. Customs and Border Protection are using new import requirements. The FDA's import software screening program (PREDICT) and the U.S. Custom's ACE software program require more information from the foreign source(s).

Speaker: Casper Uldriks | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Susanne Manz

Quality is not an Organization

What does Quality mean to you? Is it a noun meaning an attribute or characteristic measured against a standard or customer requirement? Is it a state of product being free from defects? Is it an organization within your company that is responsible for creating inspection standards or a quality system? Or is it something more? It can be something more powerful for your company.

Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Susanne Manz

Essentials of Validation - IQ, OQ, PQ

Validation is an important element of the Quality System Regulations and ISO13485.

Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
John E Lincoln

Verification vs Validation-Product, Process or Equipment and QMS Software

The verification and validation of regulated software is coming under increased scruinty by the U.S. FDA.

Speaker: John E Lincoln | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Carolyn Troiano

Computer System Validation (CSV) for FDA-Regulated Computers

The Webinar will focus on the importance of ensuring that the validation of an FDA-regulated computer system will meet compliance guidelines.

Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Teri C. Soli

Water System Biofilm Control and Microbial Monitoring Myths

It is an unfortunate fact that most water systems today have been designed and are operated and controlled using at least some traditional concepts and methods that are downright wrong.

Speaker: Teri C. Soli | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
John N. Zorich

2-Hour Virtual Seminar on Valid Statistical Rationales for Sample Sizes

This webinar explains the logic behind sample-size choice for several statistical methods that are commonly used in verification or validation efforts, and how to express a valid statistical justification for a chosen sample size.

Speaker: John N. Zorich | View Anytime | Duration: 2 Hours | Price: $240.00 | View Details
John N. Zorich

Better Alternatives to AQL Sampling Plans for Risk Management in Incoming QC

The pros and cons of the 2 most widely used sampling plans (ANSI Z1.4, and Squeglia's C=0) are examined in detail, focusing especially on the weaknesses of such plans in regards to meeting regulatory requirements.

Speaker: John N. Zorich | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
John N. Zorich

Process Validation: Statistical Justification for Sample Size and the Use of Only 3 Lots

This webinar explains how to choose and justify a sample-size for Lots that are included in Process Validation studies.

Speaker: John N. Zorich | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
John N. Zorich

Valid Statistical Rationales for Sample Sizes

This webinar explains the logic behind sample-size choice for several statistical methods that are commonly used in verification or validation efforts, and how to express a valid statistical justification for a chosen sample size.

Speaker: John N. Zorich | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Michael Abitz

Fishbone Diagramming

Fishbone Diagramming is an analytical approach used to identify and solve problems. Analysis is presented in the Seven Basic Tools of Quality in addition to advanced methods used to increase organizations effectiveness, efficiency and reliability.

Speaker: Michael Abitz | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Robert J. Russell

Latin America Regulatory Compliance: Current Challenges in Argentina, Brazil and Mexico

The Latin America Regulatory compliance requirement training/webinar will cover topics across the full Life-Cycle of Company & Product licensing in the key markets of Latin America.

Speaker: Robert J. Russell | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Edwin Waldbusser

Software Validation for the New FDA Inspections

This course will teach how to conduct a software validation program that will satisfy FDA requirements and produce a safe product.

Speaker: Edwin Waldbusser | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Edwin Waldbusser

How to Conduct a Human Factors - Usability Validation Test following ISO 62366 and the 2016 FDA Guidance

This webinar will explain the procedure described in ISO62366 and the 2016 FDA Guidance for a compliant human factors/usability validation.

Speaker: Edwin Waldbusser | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Dennis Taylor

Mastering Excel Pivot Tables

PivotTable capabilities are enormous; among its many tools and features.

Speaker: Dennis Taylor | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Steven Wachs

Determining Sample Size: What Sample Size Should I Use?

The webinar will provide important considerations when selecting sample sizes for specific applications.

Speaker: Steven Wachs | View Anytime | Duration: 75 Minutes | Price: $190.00 | View Details
Casper Uldriks

3-Hour Virtual Seminar on FDA's Scrutiny of Social Media Promotion

FDA steadily expands the scope and restrictions for promotion of products under its jurisdiction. Whatever and where ever to want to talk about your product, just assume your talking to FDA.

Speaker: Casper Uldriks | View Anytime | Duration: 3 Hours | Price: $340.00 | View Details
Nancy Knettell

Software As a Medical Device (SaMD) New IVDR Document Requirements

This course is essential for IVD Medical Device companies interested in ensuring their software enabled medical Devices or Software as an IVD Medical Device is compliant to the new Software requirements in the IVDR 2022 regulations avoiding revenue interruptions that can result from failed unannounced audits.

Speaker: Nancy Knettell | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
John N. Zorich

2-Hour Virtual Seminar on Valid Statistical Rationales for Sample Sizes

This webinar explains the logic behind sample-size choice for several statistical methods that are commonly used in verification or validation efforts, and how to express a valid statistical justification for a chosen sample size.

Speaker: John N. Zorich | View Anytime | Duration: 2 Hours | Price: $240.00 | View Details
John N. Zorich

Valid Statistical Rationales for Sample Sizes

This webinar explains the logic behind sample-size choice for several statistical methods that are commonly used in verification or validation efforts, and how to express a valid statistical justification for a chosen sample size.

Speaker: John N. Zorich | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Carolyn Troiano

FDA's New Draft Guidance on Software and Device Changes and the 510(k)

The first guidance document clarifies key terms and provides insight as to how a risk assessment can help medical device manufacturers to evaluate whether a new 510(k) is required.

Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Joy McElroy

GLPs: How are they Associated with GMPs and SOPs

Good Laboratory Practices (GLPs), CFR part 58 is a set of guidelines for conducting nonclinical laboratory studies that support or are intended to support applications for research or marketing permits for products such as food and color additives, human and animal drugs, medical devices for human use, biological products and electronic products that are regulated by the FDA.

Speaker: Joy McElroy | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Ginette Collazo

Training in Human Error: Reducing Training Related Errors

We will discuss elements of the training programs like curricula, training management systems, training effectiveness and other important elements of a compliant training program.

Speaker: Ginette Collazo | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Susanne Manz

Secrets to Writing Effective SOPs for Medical Device QMS

Standard Operating Procedures (SOPs) are a critical ingredient in an effective and efficient Quality Management System. SOPs are typically one of the first things an investigator asks for in an inspection.

Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Susanne Manz

Death By CAPA - Does your CAPA Program Need a CAPA?

This webinar will help you establish an efficient and effective CAPA (Corrective and Preventive Action) process leading to improved quality and compliance for your company.

Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Martin K. Behr, III

3-Hour Virtual Seminar on The "New NAFTA": The USMCA

The North America Free Trade Agreement (NAFTA) comprises Canada, the U.S. and Mexico, an agreement which has eliminated barriers to trade, promoted conditions of fair competition, increased investment opportunities, provided protection for intellectual property rights, and established procedures for the resolution of disputes.

Speaker: Martin K. Behr, III | View Anytime | Duration: 3 Hours | Price: $340.00 | View Details
Susanne Manz

Quality is not an Organization

What does Quality mean to you? Is it a noun meaning an attribute or characteristic measured against a standard or customer requirement? Is it a state of product being free from defects? Is it an organization within your company that is responsible for creating inspection standards or a quality system? Or is it something more? It can be something more powerful for your company.

Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Susanne Manz

Essentials of Validation - IQ, OQ, PQ

Validation is an important element of the Quality System Regulations and ISO13485. This course will cover the requirements the essentials of validation. You'll learn about what processes needed to be validated and what steps you need to take to validate processes.

Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Robert J. Russell

Drug Master Files: Understanding and Meeting your Regulatory and Processing Responsibilities

This combined Quality Agreement and DMF (Drug Master Files) training will discuss the advantages for suppliers and drug product manufacturers developing these arrangements together.

Speaker: Robert J. Russell | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Angela Bazigos

Key Factors to Write an Effective Standard Operating Procedure (SOP) and Work Instructions (WIs)

This webinar will instruct the participant on how to write, organize, and maintain SOPs and train personnel in a way that will ensure compliance in a way that is concise, reproducible and easy to follow. It will begin with a strategic view of SOPs in a company and how SOPs can help streamline operations in addition to ensuring regulatory compliance.

Speaker: Angela Bazigos | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Edwin Waldbusser

21 CFR Part 11 - Compliance for Electronic Records and Signatures

This Webinar will explain what 21 CFR Part 11 is, why it is important to FDA regulated companies and how conformance to Part 11 differs from just having good IT security. Procedures for controlling electronic signatures and electronic records as described in the FDA Guidance will be explained.

Speaker: Edwin Waldbusser | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Edwin Waldbusser

How to Conduct a Human Factors - Usability Validation Test following ISO 62366 and the 2016 FDA Guidance

This webinar will explain the procedure described in ISO62366 and the 2016 FDA Guidance for a compliant human factors/usability validation.

Speaker: Edwin Waldbusser | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Michael Abitz

Fishbone Diagramming

Fishbone Diagramming is an analytical approach used to identify and solve problems. Analysis is presented in the Seven Basic Tools of Quality in addition to advanced methods used to increase organizations effectiveness, efficiency and reliability.

Speaker: Michael Abitz | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Karl J Hemmerich

Accelerated Aging Techniques for Medical Device Packaging

Accelerated aging (AA) is testing that uses aggravated conditions of heat, oxygen, sunlight, vibration, chemicals, etc. to speed up the normal aging processes of items. It is used to help determine the long-term effects of expected levels of stress within a shorter time, usually in a laboratory by controlled standard test methods.

Speaker: Karl J Hemmerich | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Angela Bazigos

How to Implement Lean Documents and Lean Document Control to Cut Costs, while Maintaining Compliance with Regulatory Authority Requirements

Just as a manufacturing process produces a product, controlled documents are the product of a business process. Just as in manufacturing, a product cannot move forward if it is waiting for component parts, a document cannot move forward if it is waiting for information, or if its use is constrained by other documents.

Speaker: Angela Bazigos | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Steve Gompertz

The 7 Habits of Highly Effective Project Managers

Too often Project Leaders and Managers fall into the role due to demonstrated technical competence.

Speaker: Steve Gompertz | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
John N. Zorich

2-Hour Virtual Seminar on Valid Statistical Rationales for Sample Sizes

This webinar explains the logic behind sample-size choice for several statistical methods that are commonly used in verification or validation efforts, and how to express a valid statistical justification for a chosen sample size.

Speaker: John N. Zorich | View Anytime | Duration: 2 Hours | Price: $240.00 | View Details
John N. Zorich

Process Validation: Statistical Justification for Sample Size and the Use of Only 3 Lots

This webinar explains how to choose and justify a sample-size for Lots that are included in Process Validation studies.

Speaker: John N. Zorich | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
John N. Zorich

Valid Statistical Rationales for Sample Sizes

This webinar explains the logic behind sample-size choice for several statistical methods that are commonly used in verification or validation efforts, and how to express a valid statistical justification for a chosen sample size.

Speaker: John N. Zorich | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Danielle DeLucy

Best Practices for Deviation Investigations

This webinar will help attendees understand the fundamental steps of a deviation investigation with focus on using facts and objective evidence to arrive at root cause and CAPA.

Speaker: Danielle DeLucy | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Charles H. Paul

3-Hour Virtual Seminar on Project Management for Non-Project Managers

This webinar will address those project management critical tasks within each project phase that must be performed flawlessly for effective project execution to occur and will provide the foundation and direction for future study of the subject.

Speaker: Charles H. Paul | View Anytime | Duration: 3 Hours | Price: $340.00 | View Details
Todd B. Graham

Vendor Qualification - How to Design and Implement an Efficient and Compliant Vendor Program

This webinar will tell you what you need to know to design a compliant vendor program, implement it throughout the organization, manage the necessary documentation and effectively communicate with vendors your requirements, needs and issues.

Speaker: Todd B. Graham | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
John E Lincoln

Root Cause Analysis - Starting at the Beginning

CAPA and the related actions of Failure Investigation and Root Cause Analysis (RCA) is a major tool in product complaint, non-conformance, and OOS failure investigations, and hazard analysis / risk management and mitigation activities.

Speaker: John E Lincoln | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
John E Lincoln

EU ISO 13485:2016 Medical Device Quality Management System

This webinar will examine the basic elements of the EU's QMS, ISO 13485, how to implement, areas of major concern and regulatory expectations, and how the system works together. It will examine the underlying causes for major regulated medical device industry QMS failings, as well as how ISO 13485 interfaces with the EU MDR (Medical Device Regulation).

Speaker: John E Lincoln | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
John E Lincoln

Project Management for FDA-Regulated Companies

This webinar is not a project management certification course. It is designed to provide the non-project manager with the tools / techniques necessary to assist in achieving a result or deliverable to achieve that end, and document the activity over time.

Speaker: John E Lincoln | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Michael Esposito

2- Hour Virtual Seminar on SOP Writing, Training and Compliance in the Pharmaceutical Industry

Standard Operating Procedures (SOPs) are the basis for a large part of the day-to-day training that most pharmaceutical employees are required to perform. Still, it is not widely understood the extent of the commitments we make when we write an SOP or how the writing of the SOP can have a positive or negative impact on training or job performance. For example, there is an expectation that procedures describe the most critical processes for product manufacturing and will be followed consistently, with few if any deviations.

Speaker: Michael Esposito | View Anytime | Duration: 2 Hours | Price: $240.00 | View Details
Carolyn Troiano

Computer System Validation (CSV) for FDA-Regulated Computers

The Webinar will focus on the importance of ensuring that the validation of an FDA-regulated computer system will meet compliance guidelines.

Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Dr. Afsaneh Motamed Khorasani

Good Documentation Guideline (Chapter 1029 USP)

Good Documentation Practices (GDP) is a critical and essential part of a regulated environment (pharmaceutical and medical device manufacturing, R&D, laboratories and clinical trials). Compliance with GDP ensures an auditable account of work. It ensures integrity and control of documents and is a key requirement for a developed quality system.

Speaker: Dr. Afsaneh Motamed Khorasani | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Dr. Afsaneh Motamed Khorasani

Good Documentation and Record Keeping Best Practices (FDA & EMA)

Good documentation Practices (GDP) is an essential factor that needs to be closely followed by the personnel in any regulated environment as a process for a successful project completion including observations of unanticipated responses that are required to be accurately recorded and verified.

Speaker: Dr. Afsaneh Motamed Khorasani | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Casper Uldriks

Responsibility for Off-label Claims in Social Media

FDA's sweeping definition of labeling includes what is said or represented, even by images, in a social media platform.

Speaker: Casper Uldriks | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Casper Uldriks

3-Hour Virtual Seminar on FDA's Scrutiny of Social Media Promotion

FDA steadily expands the scope and restrictions for promotion of products under its jurisdiction. Whatever and where ever to want to talk about your product, just assume your talking to FDA.

Speaker: Casper Uldriks | View Anytime | Duration: 3 Hours | Price: $340.00 | View Details
Casper Uldriks

Responsibility for Off-label Claims in Social Media

FDA's sweeping definition of labeling includes what is said or represented, even by images, in a social media platform.

Speaker: Casper Uldriks | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Peter Vishton P.E.

FDA - Is Your cGMP Water System Ready for their Visit?

cGMP pharmaceutical water systems require specific Design, Documentation, Manufacturing, Installation, Testing, Commissioning, Start Up, Validation, Quality Testing and Extended Operation to become available for pharmaceutical manufacturing of products for sale.

Speaker: Peter Vishton P.E. | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
John E Lincoln

Verification vs Validation-Product, Process or Equipment and QMS Software

The verification and validation of regulated software is coming under increased scruinty by the U.S. FDA.This webinar will address the use of the FDA, GAMP, 21 CFR Part 11,"Electronic Records"/"Electronic Signatures", IEC 62304, and other applicable industry software validation models, coupled with the ISO 14971/ICH Q9 Product Risk Management models, to plan, structure, run, and document acceptable software validations.

Speaker: John E Lincoln | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Dennis Taylor

2-Hour Virtual Seminar on Mastering Excel Pivot Tables

You will learn the following in this webinar, The quickest and best ways to create PivotTables and Pivot Charts, including these capabilities: The following subjects will be covered in detail:

Speaker: Dennis Taylor | View Anytime | Duration: 2 Hours | Price: $240.00 | View Details
Susanne Manz

Root Cause Analysis for CAPA - Myths, Challenges, and Best Practices

This webinar will help you understand the critical ingredients for conducting an effective root cause analysis. You will learn about FDA expectations, tools and techniques, and tips for conducting and documenting root cause analysis. We will discuss the myths, challenges, and best practices for this critical process. We'll also cover the essentials of doing a failure investigation.

Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Susanne Manz

Quality is not an Organization

What does Quality mean to you? Is it a noun meaning an attribute or characteristic measured against a standard or customer requirement? Is it a state of product being free from defects? Is it an organization within your company that is responsible for creating inspection standards or a quality system? Or is it something more? It can be something more powerful for your company.

Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Edwin Waldbusser

Software Validation for the New FDA Inspections

This course will teach how to conduct a software validation program that will satisfy FDA requirements and produce a safe product. We will explain the role of risk analysis in validation. How software requirements are used in validation will be described. This course is NOT a programming course. We will discuss what must be done but will not discuss methods to execute necessary testing.

Speaker: Edwin Waldbusser | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Robert J. Russell

BREXIT - What's Changing for Life Science Product License Holders-Manufacturers and What you Need to do Right Now

The United Kingdom submitted its' notification on 29 March 2017 to withdraw from the European Union. This means that unless a withdrawal agreement establishes another date, all EU primary and secondary Laws cease to apply to the UK from 30 March 2019 going forward.

Speaker: Robert J. Russell | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Robert J. Russell

Latin America Regulatory Compliance: Current Challenges in Argentina, Brazil and Mexico

The Latin America Regulatory compliance requirement training/webinar will cover topics across the full Life-Cycle of Company & Product licensing in the key markets of Latin America. Written Regulations vs. Skillful Negotiation will be explained across every critical topic. The importance of local resources, Agency meetings and knowing how to navigate the regulatory landscape will accelerate country establishment and successful product licensing.

Speaker: Robert J. Russell | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Susanne Manz

Essentials of Validation - IQ, OQ, PQ

Validation is an important element of the Quality System Regulations and ISO13485. This course will cover the requirements the essentials of validation. You'll learn about what processes needed to be validated and what steps you need to take to validate processes.

Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Michael Abitz

Fishbone Diagramming

Fishbone Diagramming is an analytical approach used to identify and solve problems. Analysis is presented in the Seven Basic Tools of Quality in addition to advanced methods used to increase organizations effectiveness, efficiency and reliability.

Speaker: Michael Abitz | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Angela Bazigos

If it Isn't Written Down, then it Didn't Happen: Complying with FDA's Good Documentation Practices

Good documentation practice (commonly abbreviated GDP, recommended to abbreviate as GDocP to distinguish from "good distribution practice" also abbreviated GDP) is a term in the pharmaceutical and medical device industries to describe standards by which documents are created and maintained. In a pharmaceutical or medical device environment documentation needs to meet certain requirements to ensure product quality and product safety.

Speaker: Angela Bazigos | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Angela Bazigos

Audit Trail Generation and Review

This webinar will demystify audit trails and describe the benefits of audit trail for your company. Attendees will the tools required to generate compliant audit trails on a domestic and international basis and will answer the questions on how to handle systems without automated audit trails, in a compliant manner.

Speaker: Angela Bazigos | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Ginette Collazo

3-Hour Virtual Seminar on Human Error Reduction in GMP Related Environments

Human error is known to be the primary cause of quality and production losses in many industries. Although it is unlikely that human error will ever be eliminated, many human performance problems can be prevented.

Speaker: Ginette Collazo | View Anytime | Duration: 3 Hours | Price: $340.00 | View Details
Angela Bazigos

Key Factors to Write an Effective Standard Operating Procedure (SOP) and Work Instructions (WIs)

This webinar will instruct the participant on how to write, organize, and maintain SOPs and train personnel in a way that will ensure compliance in a way that is concise, reproducible and easy to follow. It will begin with a strategic view of SOPs in a company and how SOPs can help streamline operations in addition to ensuring regulatory compliance.

Speaker: Angela Bazigos | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Dennis Taylor

Excel Formulas and Functions

Built in to Excel are over 450 functions - a potent set of power tools that simplifies certain kinds of formulas and gives you a huge number of computational possibilities. Many Excel functions provide extended analytical capabilities and open the door to more efficient use of Excel.

Speaker: Dennis Taylor | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Jose Mora

Managing The Audit Function In A Global Company

This presentation focuses on the role, skills, organizational opportunities, and the benefits of an independent audit group to advise senior management on the true causes of complex situations. Although the typical setting would be in larger multi-national companies, this role can be sized to meet the needs of all companies, especially when the situations will cross national, divisional, and organizational boundaries.

Speaker: Jose Mora | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Dr. Ludwig Huber

Understanding the USP Chapter 1224 for Transfer of Analytical Methods

When validated methods are transferred between laboratories and sites, their validated state should be maintained to ensure the same reliable results in the receiving laboratory.

Speaker: Dr. Ludwig Huber | View Anytime | Duration: 75 Minutes | Price: $190.00 | View Details
Jose Mora

Scrutinizing Test Method Validation (TMV) to Verify the Performance of a Medical Device

Test method validation is an often-confusing requirement for medical devices. A fundamental issue is the role-reversal between the test method and the product or process it is designed to detect. For example, while a defect-free process is desirable, a test method must be reliable both in detecting defects and in not rejecting acceptable samples

Speaker: Jose Mora | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Dr. Ludwig Huber

2-Hour Virtual Seminar on FDA's New Enforcement of 21 CFR Part 11

FDA continues to enforce Part 11 through its ongoing Part 11 inspection and enforcement program. Just in the last 3 years FDA issued more than 30 warning letters with Part 11 related observations. Citations are related to inadequate integrity, security and availability of electronic records, including data manipulation.

Speaker: Dr. Ludwig Huber | View Anytime | Duration: 2 Hours | Price: $240.00 | View Details
Dr. Ludwig Huber

Validation and Use of Excel® Spreadsheets in FDA Regulated Environments

Excel® Applications are widely used in laboratories, offices and manufacturing e.g., for data capture, data manipulation and report generation.

Speaker: Dr. Ludwig Huber | View Anytime | Duration: 75 Minutes | Price: $190.00 | View Details
Dr. Ludwig Huber

Validation of Analytical Methods and Procedures

Analytical methods should be validated to ensure reliability, consistency and accuracy of analytical data. Method validation has been a requirement of FDA and international regulations and accreditation standards such as ISO 17025 since many years and new official guidelines have been published by FDA, EMA and USP in the last 4 years. Most often the theory is well understood but there are many questions when validation experiments are designed, conducted, and documented.

Speaker: Dr. Ludwig Huber | View Anytime | Duration: 75 Minutes | Price: $190.00 | View Details
David R Dills

FDA Issues Final Rule on Symbols in Labeling

The Food and Drug Administration (FDA or the Agency) issued this final rule revising its medical device and certain biological product labeling regulations to explicitly allow for the optional inclusion of graphical representations of information, or symbols, in labeling (including labels) without adjacent explanatory text (referred to in this document as "stand-alone symbols") if certain requirements are met.

Speaker: David R Dills | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Susanne Manz

Preparing for an FDA Inspection - What you Need to Know

Although an effective Quality System should always be inspection ready, many medical device companies make basic mistakes during inspections leading to 483s and even warning letters. This webinar can help you manage inspections efficiently and effectively.

Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Susanne Manz

3-Hour Virtual Seminar on Design Controls for Medical Devices

Design Control is considered a critical process by the FDA. Yet is still a common source of 483 and Warning Letter observations. Most importantly, Design Control is critical to product quality, ensuring safe and effective products for your customers.

Speaker: Susanne Manz | View Anytime | Duration: 3 Hours | Price: $340.00 | View Details
Teri C. Soli

Water System Mythology: Common False Beliefs for Microbial Control and Monitoring

It is an unfortunate fact that most water systems today have been designed and are operated and controlled using at least some traditional concepts and methods that are downright wrong. So how could such traditions become so ingrained and be so wrong? How could well-intentioned benchmarking be so misguided?

Speaker: Teri C. Soli | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Teri C. Soli

Water System Biofilm Control and Microbial Monitoring Myths

It is an unfortunate fact that most water systems today have been designed and are operated and controlled using at least some traditional concepts and methods that are downright wrong. So how could such traditions become so ingrained and be so wrong? How could well-intentioned benchmarking be so misguided?

Speaker: Teri C. Soli | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Edwin Waldbusser

How to Conduct a Human Factors - Usability Validation Test following ISO 62366 and the 2016 FDA Guidance

This webinar will explain the procedure described in ISO62366 and the 2016 FDA Guidance for a compliant human factors/usability validation.

Speaker: Edwin Waldbusser | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Edwin Waldbusser

21 CFR Part 11 - Compliance for Electronic Records and Signatures

This Webinar will explain what 21 CFR Part 11 is, why it is important to FDA regulated companies and how conformance to Part 11 differs from just having good IT security. Procedures for controlling electronic signatures and electronic records as described in the FDA Guidance will be explained.

Speaker: Edwin Waldbusser | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Mike Thomas

3-Hour Virtual Seminar on Mastering Excel Formulas and Functions

An Excel formula is an equation or calculation that is stored in a worksheet cell. A formula enables you to perform simple or complex calculations on numbers. So think of any scenario that involves addition, subtraction, division or multiplication and that's where you'd use a formula.

Speaker: Mike Thomas | View Anytime | Duration: 3 Hours | Price: $340.00 | View Details
Roger Cowan

Pharmaceutical Compressed Air - Quality GMP Requirements - What you need to know to Meet FDA and International Quality Standards

Compressed air for pharmaceutical use is considered a critical utility as many of its applications involve direct contact with the pharmaceutical product. The design, construction and monitoring of a compressed air system is essential for maintaining a quality system without contamination of the product. Proper testing of compressed air quality according to international standards is important for both validation and ongoing monitoring of the system.

Speaker: Roger Cowan | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Ginette Collazo

Supervising a Human Error Free Environment: You can do a Lot More than you Think

Human error is known to be the major cause of quality and production losses in many industries. Although it is unlikely that human error will ever be totally eliminated, many human performance problems can be prevented. Human errors start at the design stage. From procedures, training, supervision, and workplace environment many variables that affect human behavior CAN be manipulated reducing the likelihood of these occurrences.

Speaker: Ginette Collazo | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Ginette Collazo

Tools for Human Error Reduction

Human error is known to be the major cause of quality and production losses in many industries. Although it is unlikely that human error will ever be totally eliminated, many human performance problems can be prevented. Human errors start at the design stage. From procedures, training, and workplace environment many variables that affect human behavior CAN be manipulated reducing the likelihood of these occurrences.

Speaker: Ginette Collazo | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Robert J. Russell

EU Medical Device Regulation (MDR) - Updated CE Marking Process & ISO 13485:2016 Expectations

This EU Medical Device Regulation (MDR) 90-minute webinar will discuss the recently developed regulation and its impact on the future compliance and registration of medical devices in the EU.

Speaker: Robert J. Russell | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Robert J. Russell

Latin America Regulatory Compliance: Current Challenges in Argentina, Brazil and Mexico

The Latin America Regulatory compliance requirement training/webinar will cover topics across the full Life-Cycle of Company & Product licensing in the key markets of Latin America. Written Regulations vs. Skillful Negotiation will be explained across every critical topic. The importance of local resources, Agency meetings and knowing how to navigate the regulatory landscape will accelerate country establishment and successful product licensing.

Speaker: Robert J. Russell | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Robert J. Russell

3-Hour Virtual Seminar on Japan - Regulatory Filing Requirements and Compliance Processes for Life Sciences

This 3-Hour webinar covers the details of the Regulatory Requirements for a wide-range of Life Science products in Japan: Pharmaceuticals, Biologics, Medical Devices and Combination Products. The syllabus also covers the change in Japan caused by the re-write of the Pharmaceutical Affairs Law [PAL] into the Pharmaceuticals & Medical Device Law [PMDL] and the country's latest update to GMP requirements.

Speaker: Robert J. Russell | View Anytime | Duration: 3 Hours | Price: $340.00 | View Details
Dr. Afsaneh Motamed Khorasani

Good Documentation and Record Keeping Best Practices (FDA & EMA)

Good documentation Practices (GDP) is an essential factor that needs to be closely followed by the personnel in any regulated environment as a process for a successful project completion including observations of unanticipated responses that are required to be accurately recorded and verified.

Speaker: Dr. Afsaneh Motamed Khorasani | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Carolyn Troiano

Computer System Validation (CSV) for FDA-Regulated Computers

The Webinar will focus on the importance of ensuring that the validation of an FDA-regulated computer system will meet compliance guidelines.

Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Wayne Taylor

Medical Devices - Complying With 820.250 Statistical Methods

Learn how to manage Statistics including establishing a policy along with procedures relative to specific areas of applications. Highlighted are statistical techniques for:

Speaker: Wayne Taylor | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Charles H. Paul

Project Management for Non-Project Managers

This webinar will address those project management critical tasks within each project phase that must be performed flawlessly for effective project execution to occur and will provide the foundation and direction for future study of the subject.

Speaker: Charles H. Paul | View Anytime | Price: $190.00 | View Details
Gwendolyn Wise-Blackman

Auditing Laboratories Conducting Assays Supporting Biologics

Sponsors or consultants auditing labs on behalf of a pharmaceutical or biopharmaceutical company need strong tools for preparing and conducting audits.Careful consideration of the work that will be performed at the laboratory provides a working framework for the content of the audit.

Speaker: Gwendolyn Wise-Blackman | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Michael Brodsky

ISO-IEC 17025:2017 Update Introduction: Everything Old is New Again

Many laboratories have successfully developed and implementied a functional quality management system that not only complies with the management and technical requirements of ISO/IEC 17025:2005 but also meets their needs.

Speaker: Michael Brodsky | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Jose Mora

Scrutinizing Test Method Validation (TMV) to Verify the Performance of a Medical Device

Test method validation is an often-confusing requirement for medical devices. A fundamental issue is the role-reversal between the test method and the product or process it is designed to detect. For example, while a defect-free process is desirable, a test method must be reliable both in detecting defects and in not rejecting acceptable samples

Speaker: Jose Mora | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Peggy Berry

Complaint Handling

The information obtained will enable preparation of effective internal systems for receiving, investigating and responding to product complaints during both the investigational and commercial stages. The webinar will address aspects of the review process, SOP preparation, investigation documentation, and response to complainants.

Speaker: Peggy Berry | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Robert J. Russell

Drug Master Files: Understanding and Meeting your Regulatory and Processing Responsibilities

This combined Quality Agreement and DMF (Drug Master Files) training will discuss the advantages for suppliers and drug product manufacturers developing these arrangements together.

Speaker: Robert J. Russell | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Ginette Collazo

Controlling Human Error in the Manufacturing Floor

Human error is known to be the major cause of quality and production losses in many industries. Although it is unlikely that human error will ever be totally eliminated, many human performance problems can be prevented. Human errors start at the design stage. From procedures, training, and workplace environment many variables that affect human behavior CAN be manipulated reducing the likelihood of these occurrences.

Speaker: Ginette Collazo | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Miles Hutchinson

Introduction to Payroll Law

Are you responsible for payroll or employer tax withholding compliance? Or maybe you were recently hired or promoted into the payroll department. During your indoctrination you are surprised at all the interesting things to do and how important this role is to the success of the company.

Speaker: Miles Hutchinson | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
John E Lincoln

Dietary Supplements CGMPS - 21 CFR 111 Compliance

21 CFR part 111 ("the DS CGMP rule") requires persons who manufacture, package, label, or hold a dietary supplement to establish and follow current good manufacturing practice-the CGMPs. This is to ensure the quality of the dietary supplement and to ensure that the dietary supplement is packaged and labeled as specified in the master manufacturing record.

Speaker: John E Lincoln | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
John E Lincoln

3-Hour Virtual Seminar on DHF, DMR, DHR, TF , Design Dossiers - The Requirements

This webinar will examine the existing and proposed requirements for the U.S. FDA's DHF including its derivative documents, the DMR and DHR.

Speaker: John E Lincoln | View Anytime | Duration: 3 Hours | Price: $340.00 | View Details
Dennis Taylor

Time-Saving Excel Tips, Tricks and 100 Shortcuts

Microsoft Excel has a tremendous amount of capability and features and is filled with shortcuts and methods not always visible to the casual user. Whether it's a keystroke shortcut or a hidden command sequence, such shortcuts can make you much more proficient and productive as you use this powerful and popular software.

Speaker: Dennis Taylor | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Dennis Taylor

Excel Formulas and Functions

Built in to Excel are over 450 functions - a potent set of power tools that simplifies certain kinds of formulas and gives you a huge number of computational possibilities. Many Excel functions provide extended analytical capabilities and open the door to more efficient use of Excel.

Speaker: Dennis Taylor | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Dennis Taylor

2-Hour Virtual Seminar on Mastering Excel Pivot Tables

You will learn the following in this webinar, The quickest and best ways to create PivotTables and Pivot Charts, including these capabilities:

Speaker: Dennis Taylor | View Anytime | Duration: 2 Hours | Price: $240.00 | View Details
John N. Zorich

Valid Statistical Rationales for Sample Sizes

This webinar explains the logic behind sample-size choice for several statistical methods that are commonly used in verification or validation efforts, and how to express a valid statistical justification for a chosen sample size.

Speaker: John N. Zorich | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Susanne Manz

Root Cause Analysis for CAPA - Myths, Challenges, and Best Practices

This webinar will help you understand the critical ingredients for conducting an effective root cause analysis. You will learn about FDA expectations, tools and techniques, and tips for conducting and documenting root cause analysis. We will discuss the myths, challenges, and best practices for this critical process. We'll also cover the essentials of doing a failure investigation.

Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Edwin Waldbusser

Medical Device Software Validation

This course will teach how to conduct a software validation program that will satisfy FDA requirements and produce a safe product. We will explain the role of risk analysis in validation. How software requirements are used in validation will be described. This course is NOT a programming course. We will discuss what must be done but will not discuss methods to execute necessary testing.

Speaker: Edwin Waldbusser | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Michael Esposito

Onboarding Employees in a GMP Environment: Best Practices for Foundational Employee Success

The FDA's expectations for training new employees are summed up in 21 CFR 211.25(a), i.e., pharmaceutical professionals require the education, training and experience to complete their job functions. Onboarding new or transferred employees in a Pharmaceutical Good Manufacturing Practices (GMP) environment and ensuring compliance with these requirements create some unique challenges.

Speaker: Michael Esposito | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
John N. Zorich

Better Alternatives to AQL Sampling Plans for Risk Management in Incoming QC

The pros and cons of the 2 most widely used sampling plans (ANSI Z1.4, and Squeglia's C=0) are examined in detail, focusing especially on the weaknesses of such plans in regards to meeting regulatory requirements. Real-world examples are provided for how using such sampling plans leads to production of non-conforming product.

Speaker: John N. Zorich | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Ginette Collazo

3-Hour Virtual Seminar on the Human Error Tool Box: A Practical Approach to Human Error

This course provides a practical approach that will allow you to understand human behavior in the workplace, to assess your current human reliability situation, and support human error reduction efforts at your site.

Speaker: Ginette Collazo | View Anytime | Duration: 3 Hours | Price: $340.00 | View Details
Michael Abitz

Fishbone Diagramming

Fishbone Diagramming is an analytical approach used to identify and solve problems. Analysis is presented in the Seven Basic Tools of Quality in addition to advanced methods used to increase organizations effectiveness, efficiency and reliability.

Speaker: Michael Abitz | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
John E Lincoln

Verification vs Validation-Product, Process or Equipment and QMS Software

The verification and validation of regulated software is coming under increased scruinty by the U.S. FDA.This webinar will address the use of the FDA, GAMP, 21 CFR Part 11,"Electronic Records"/"Electronic Signatures", IEC 62304, and other applicable industry software validation models, coupled with the ISO 14971/ICH Q9 Product Risk Management models, to plan, structure, run, and document acceptable software validations.

Speaker: John E Lincoln | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Dr. Ludwig Huber

Validation and Use of Excel® Spreadsheets in FDA Regulated Environments

Excel® Applications are widely used in laboratories, offices and manufacturing e.g., for data capture, data manipulation and report generation.

Speaker: Dr. Ludwig Huber | View Anytime | Duration: 75 Minutes | Price: $190.00 | View Details
Dr. Ludwig Huber

Validation of Analytical Methods and Procedures

Analytical methods should be validated to ensure reliability, consistency and accuracy of analytical data. Method validation has been a requirement of FDA and international regulations and accreditation standards such as ISO 17025 since many years and new official guidelines have been published by FDA, EMA and USP in the last 4 years. Most often the theory is well understood but there are many questions when validation experiments are designed, conducted, and documented.

Speaker: Dr. Ludwig Huber | View Anytime | Duration: 75 Minutes | Price: $190.00 | View Details
Carolyn Troiano

In-Depth Testing of Computer Systems Regulated by FDA

This webinar will cover all aspects of testing to ensure that a computer system regulated by FDA "does what it purports to do," as per the guidance on computer system validation (CSV) from FDA, first issued in 1983.

Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Edwin Waldbusser

Medical Device Software Validation Meeting FDA Regulations

This course will teach how to conduct a software validation program for medical devices containing software that will satisfy FDA requirements and produce a safe product. We will explain the role of risk analysis in validation. How software requirements are used in validation will be described.

Speaker: Edwin Waldbusser | View Anytime | Price: $190.00 | View Details
Danielle DeLucy

Handling OOS Test Results and Completing Robust Investigations

This webinar will review the regulatory requirements for investigating an OOS Investigation. The responsibilities of the analyst, the supervisor and QA will be discussed.

Speaker: Danielle DeLucy | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Mike Thomas

Excel Data Visualization - Charts and Infographics

In this session, participants will learn how to visually represent your data using both traditional charts (bar charts, line charts etc.) as well as how to do the same using some of Excel's non-charting tools.

Speaker: Mike Thomas | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Joy McElroy

Writing Validation Master Plans; Best Practices for Writing a Compliant Document

This webinar will discuss the major components of Validation Master Plans. It will discuss how the VMP is different from Validation SOPs.

Speaker: Joy McElroy | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
John N. Zorich

Process Validation: Statistical Justification for Sample Size and the Use of Only 3 Lots

This webinar explains how to choose and justify a sample-size for Lots that are included in Process Validation studies.

Speaker: John N. Zorich | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
John N. Zorich

2-Hour Virtual Seminar on Valid Statistical Rationales for Sample Sizes

This webinar explains the logic behind sample-size choice for several statistical methods that are commonly used in verification or validation efforts, and how to express a valid statistical justification for a chosen sample size.

Speaker: John N. Zorich | View Anytime | Duration: 2 Hours | Price: $240.00 | View Details
Todd B. Graham

SOP's for Bioanalytical Methods Validation

The webinar will include the following critical information you will need:

Speaker: Todd B. Graham | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Ginette Collazo

Tools for Human Error Reduction

Human error is known to be the major cause of quality and production losses in many industries. Although it is unlikely that human error will ever be totally eliminated, many human performance problems can be prevented. Human errors start at the design stage. From procedures, training, and workplace environment many variables that affect human behavior CAN be manipulated reducing the likelihood of these occurrences.

Speaker: Ginette Collazo | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Douglas Cohen

How to Create an Export Compliance Program Under the Export Administration Regulations(EARs)

The US Government regulates the export of information, commodities, technology, and software considered important to US national security, economic competition, and foreign policy.

Speaker: Douglas Cohen | View Anytime | Price: $190.00 | View Details
Robert J. Russell

3-Hour Virtual Seminar on Japan - Regulatory Filing Requirements and Compliance Processes for Life Sciences

This 3-Hour webinar covers the details of the Regulatory Requirements for a wide-range of Life Science products in Japan: Pharmaceuticals, Biologics, Medical Devices and Combination Products. The syllabus also covers the change in Japan caused by the re-write of the Pharmaceutical Affairs Law [PAL] into the Pharmaceuticals & Medical Device Law [PMDL] and the country's latest update to GMP requirements.

Speaker: Robert J. Russell | View Anytime | Duration: 3 Hours | Price: $340.00 | View Details
Robert J. Russell

Latin America Regulatory Compliance: Current Challenges in Argentina, Brazil and Mexico

The Latin America Regulatory compliance requirement training/webinar will cover topics across the full Life-Cycle of Company & Product licensing in the key markets of Latin America. Written Regulations vs. Skillful Negotiation will be explained across every critical topic. The importance of local resources, Agency meetings and knowing how to navigate the regulatory landscape will accelerate country establishment and successful product licensing.

Speaker: Robert J. Russell | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Susanne Manz

Essentials of Validation - IQ, OQ, PQ

Validation is an important element of the Quality System Regulations and ISO13485. This course will cover the requirements the essentials of validation. You'll learn about what processes needed to be validated and what steps you need to take to validate processes.

Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Angela Bazigos

If it Isn't Written Down, then it Didn't Happen: Complying with FDA's Good Documentation Practices

Good documentation practice (commonly abbreviated GDP, recommended to abbreviate as GDocP to distinguish from "good distribution practice" also abbreviated GDP) is a term in the pharmaceutical and medical device industries to describe standards by which documents are created and maintained. In a pharmaceutical or medical device environment documentation needs to meet certain requirements to ensure product quality and product safety.

Speaker: Angela Bazigos | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
John E Lincoln

Design History Files (DHF), Device Master Records (DMR), Device History Records (DHR), Technical Files , Design Dossiers - The Requirements

It will also consider the European Union's MDD TF/DD requirements, and evaluate the documents' differing purposes / goals, as well as the two different device classification schemes. Required and desirable contents will be discussed.

Speaker: John E Lincoln | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Jonnie T. Keith

Putting the Quality in Audit Reports

How well you communicate that information is critical to getting management's acceptance of your findings and their agreement with your recommendations.

Speaker: Jonnie T. Keith | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Steven Laurenz

Quality Risk Management Overview

Attendees will come away with the ability to recognize the purpose and value of Quality Risk Management QRM.

Speaker: Steven Laurenz | View Anytime | Price: $190.00 | View Details
Angela Bazigos

3-Hour Virtual Seminar on Project Management for Computer Systems Validation

Project Management is defined as the planning and organization of an organization's resources in order to move a specific task, event or duty toward completion.

Speaker: Angela Bazigos | View Anytime | Duration: 3 Hours | Price: $340.00 | View Details
Susanne Manz

Knock, Knock, Who's There? Preparing for an FDA Inspection

Are you ready for that knock on your door? Although an effective Quality System should always be inspection ready, many medical device companies make basic mistakes during inspections leading to 483s and even warning letters.

Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Ginette Collazo

3-Hour Virtual Seminar on Human Error Reduction in GMP Related Environments

Human error is known to be the primary cause of quality and production losses in many industries. Although it is unlikely that human error will ever be eliminated, many human performance problems can be prevented.

Speaker: Ginette Collazo | View Anytime | Duration: 3 Hours | Price: $340.00 | View Details
Prof. Dr. h.c. Frank Stein

ISO 62304 How to Create a Medical Software Development File?

This course will give an introduction how to develop medical software under the requirements of the ISO 62304 and how to apply these in a medical software development project and how a smart application during the medical software development and in the post market process is possible.

Speaker: Prof. Dr. h.c. Frank Stein | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Prof. Dr. h.c. Frank Stein

MDSAP - How to Implement MDSAP-Requirements into your ISO 13485 Quality Management System?

This course will give an introduction into the Medical Device Single Audit Program (MDSAP).

Speaker: Prof. Dr. h.c. Frank Stein | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Ginette Collazo

3-Hour Virtual Seminar on Human Error Reduction in the Manufacturing Floor

Human error is known to be the primary cause of quality and production losses in many industries. Although it is unlikely that human error will ever be eliminated, many human performance problems can be prevented.

Speaker: Ginette Collazo | View Anytime | Duration: 3 Hours | Price: $340.00 | View Details
Jose Mora

Controlled Document System for a Life Sciences Manufacturing Plant - Principles of Lean Documents and Lean Configuration

All life science businesses are required to maintain their Quality Management System (QMS) processes in a state of control, via controlled documents and objective evidence in the form of records.

Speaker: Jose Mora | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Jose Mora

Scrutinizing Test Method Validation (TMV) to Verify the Performance of a Medical Device

Test method validation is an often-confusing requirement for medical devices. A fundamental issue is the role-reversal between the test method and the product or process it is designed to detect. For example, while a defect-free process is desirable, a test method must be reliable both in detecting defects and in not rejecting acceptable samples

Speaker: Jose Mora | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Jose Mora

21 CFR Part 820 - Quality System Regulation - Applying Principles of Lean Documents and Lean Configuration

All life science businesses are required to maintain their Quality Management System (QMS) processes in a state of control, via controlled documents and objective evidence in the form of records

Speaker: Jose Mora | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Mike Thomas

3-Hour Virtual Seminar on Mastering Excel Formulas and Functions

An Excel formula is an equation or calculation that is stored in a worksheet cell. A formula enables you to perform simple or complex calculations on numbers. So think of any scenario that involves addition, subtraction, division or multiplication and that's where you'd use a formula.

Speaker: Mike Thomas | View Anytime | Duration: 3 Hours | Price: $340.00 | View Details
Teri C. Soli

Water System Biofilm Control and Microbial Monitoring Myths

It is an unfortunate fact that most water systems today have been designed and are operated and controlled using at least some traditional concepts and methods that are downright wrong. So how could such traditions become so ingrained and be so wrong? How could well-intentioned benchmarking be so misguided?

Speaker: Teri C. Soli | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Susanne Manz

Root Cause Analysis for CAPA - Myths, Challenges, and Best Practices

This webinar will help you understand the critical ingredients for conducting an effective root cause analysis. You will learn about FDA expectations, tools and techniques, and tips for conducting and documenting root cause analysis. We will discuss the myths, challenges, and best practices for this critical process. We'll also cover the essentials of doing a failure investigation.

Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Steven Wachs

Determining Sample Size: What Sample Size Should I Use?

The webinar will provide important considerations when selecting sample sizes for specific applications. The knowledge gained by attending the webinar will allow practitioners to consider the implications of sample size selection prior to conducting the study and ensure that the information obtained can be useful for decision making.

Speaker: Steven Wachs | View Anytime | Duration: 75 Minutes | Price: $190.00 | View Details
Dennis Taylor

2-Hour Virtual Seminar on Mastering Excel Pivot Tables

You will learn the following in this webinar, The quickest and best ways to create PivotTables and Pivot Charts, including these capabilities: The following subjects will be covered in detail:

Speaker: Dennis Taylor | View Anytime | Duration: 2 Hours | Price: $240.00 | View Details
Edwin Waldbusser

How to Conduct a Human Factors - Usability Validation Test following ISO 62366 and the 2016 FDA Guidance

This webinar will explain the procedure described in ISO62366 and the 2016 FDA Guidance for a compliant human factors/usability validation. HF/U validation is very different from device validation. For example, success criteria is qualitative rather than quantitative as is in device validation. Claiming success because eg. 95% of test participants did not commit a user error is not valid. Nor is 100% positive test results sufficient.

Speaker: Edwin Waldbusser | View Anytime | Price: $190.00 | View Details
Danielle DeLucy

Batch Record Review and Product Release

Most Regulatory Agencies require firms to have written procedures in place to document production and process controls, better known as batch records. Additionally, there must be written procedures for a batch record review process that demonstrate compliance.

Speaker: Danielle DeLucy | View Anytime | Price: $190.00 | View Details
Danielle DeLucy

Handling OOS Test Results and Completing Robust Investigations

This webinar will review the regulatory requirements for investigating an OOS Investigation. The responsibilities of the analyst, the supervisor and QA will be discussed.

Speaker: Danielle DeLucy | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Edwin Waldbusser

21 CFR Part 11 - Compliance for Electronic Records and Signatures

This webinar details the regulation and how it applies to computerized systems.

Speaker: Edwin Waldbusser | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Edwin Waldbusser

Software Validation for the New FDA Inspections

This course will teach how to conduct a software validation program that will satisfy FDA requirements and produce a safe product. We will explain the role of risk analysis in validation. How software requirements are used in validation will be described. This course is NOT a programming course. We will discuss what must be done but will not discuss methods to execute necessary testing.

Speaker: Edwin Waldbusser | View Anytime | Price: $190.00 | View Details
Salma Michor

The New EU Medical Device Regulation

Regulation proposals of the European Commission

Speaker: Salma Michor | View Anytime | Price: $190.00 | View Details
Dr. Ludwig Huber

2-Hour Virtual Seminar on FDA's New Enforcement of 21 CFR Part 11

FDA continues to enforce Part 11 through its ongoing Part 11 inspection and enforcement program. Just in the last 3 years FDA issued more than 30 warning letters with Part 11 related observations. Citations are related to inadequate integrity, security and availability of electronic records, including data manipulation.

Speaker: Dr. Ludwig Huber | View Anytime | Duration: 2 Hours | Price: $240.00 | View Details
Dr. Ludwig Huber

Understanding the USP Chapter 1224 for Transfer of Analytical Methods

When validated methods are transferred between laboratories and sites, their validated state should be maintained to ensure the same reliable results in the receiving laboratory.

Speaker: Dr. Ludwig Huber | View Anytime | Duration: 75 Minutes | Price: $190.00 | View Details
Dr. Ludwig Huber

Validation and Use of Excel® Spreadsheets in FDA Regulated Environments

Excel® Applications are widely used in laboratories, offices and manufacturing e.g., for data capture, data manipulation and report generation.

Speaker: Dr. Ludwig Huber | View Anytime | Duration: 75 Minutes | Price: $190.00 | View Details
Dr. Ludwig Huber

FDA's New Enforcement of 21 CFR Part 11

FDA continues to enforce Part 11 through its new Part 11 inspection and enforcement program. Just in the last 3 years, FDA issued more than 30 warning letters with Part 11 violations. Citations are related to inadequate integrity, security and availability of electronic records but also related to validation of software and computer systems. There are many questions about the program, e.g., what inspectors are looking at what are major findings.

Speaker: Dr. Ludwig Huber | View Anytime | Duration: 75 Minutes | Price: $190.00 | View Details
Joy McElroy

GLPs: How are they Associated with GMPs and SOPs

In this webinar you will learn what GLPs are, why they were created, what is the objective of GLPs, and how they relate and are associated with GMPs.

Speaker: Joy McElroy | View Anytime | Price: $190.00 | View Details
Angela Bazigos

Audit Trail Generation and Review

This webinar will demystify audit trails and describe the benefits of audit trail for your company. Attendees will the tools required to generate compliant audit trails on a domestic and international basis and will answer the questions on how to handle systems without automated audit trails, in a compliant manner.

Speaker: Angela Bazigos | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Dennis Taylor

Excel Formulas and Functions

Built in to Excel are over 450 functions - a potent set of power tools that simplifies certain kinds of formulas and gives you a huge number of computational possibilities. Many Excel functions provide extended analytical capabilities and open the door to more efficient use of Excel.

Speaker: Dennis Taylor | View Anytime | Price: $190.00 | View Details
Steven S. Kuwahara

GMP Expectations for Products Used in Early Phase IND Studies

FDA issued a guidance document covering GMP requirements for Phase 1 products. These guidelines remove some of the problems that are encountered with early phase products and are in addition to those that cover the CMC sections for IND submissions at Phase 1.

Speaker: Steven S. Kuwahara | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Jerry Lanese

Analytical Method Validation

An analytical method is a process. The FDA process validation guidance applies to test methods, like all other processes in the pharmaceutical industry. Therefore, the laboratory or laboratories must demonstrate that a test method performs as intended through the method lifecycle.

Speaker: Jerry Lanese | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Jerry Lanese

Laboratory Investigation of Out-of-Specification Results

The objective of this webinar is to develop an understanding of how a compliant laboratory handles the investigation of out-of-specification (OOS) test results and how the laboratory interfaces with other units through the laboratory investigation process. The discussion will be based on the FDA guidance on handling OOS laboratory results.

Speaker: Jerry Lanese | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Casper Uldriks

Responsibility for Off-label Claims in Social Media

FDA's sweeping definition of labeling includes what is said or represented, even by images, in a social media platform.

Speaker: Casper Uldriks | View Anytime | Price: $190.00 | View Details
Casper Uldriks

FDA's New Import Program for 2019

The FDA and U.S. Customs and Border Protection are using new import requirements. The FDA's import software screening program (PREDICT) and the U.S. Custom's ACE software program require more information from the foreign source(s). FDA's product codes and U.S. Harmonized Tariff Schedule (HTS) link the requirements. The software coding information must be correct. Otherwise, you face costly delays and possibly a refusal of the entry.

Speaker: Casper Uldriks | View Anytime | Price: $190.00 | View Details
Casper Uldriks

3-Hour Virtual Seminar on FDA's Scrutiny of Social Media Promotion

FDA steadily expands the scope and restrictions for promotion of products under its jurisdiction. Whatever and where ever to want to talk about your product, just assume your talking to FDA.

Speaker: Casper Uldriks | View Anytime | Duration: 3 Hours | Price: $340.00 | View Details
Susanne Manz

Quality is not an Organization

What does Quality mean to you? Is it a noun meaning an attribute or characteristic measured against a standard or customer requirement? Is it a state of product being free from defects? Is it an organization within your company that is responsible for creating inspection standards or a quality system? Or is it something more? It can be something more powerful for your company.

Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Susanne Manz

Essentials of Validation - IQ, OQ, PQ

Validation is an important element of the Quality System Regulations and ISO13485. This course will cover the requirements the essentials of validation. You'll learn about what processes needed to be validated and what steps you need to take to validate processes.

Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Charles H. Paul

FDA Audit Best Practices - Do's and Don'ts

This webinar will begin by discussing and emphasizing the importance of truthfulness to the process - truthfulness in performing the job on a daily basis, truthfulness in completing the regulatory documentation that is so much a part of our regulatory lives, and finally in the context of this webinar, truthfulness when interacting with FDA inspectors.

Speaker: Charles H. Paul | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Charles H. Paul

Preventing Human Error in the Life Sciences

Human Error occurs in all settings. In the world of pharmaceutical manufacturing, the result of that error can result in loss of product or at the most extreme, injury to patients.Human error is a frequent occurrence in pharmaceutical manufacturing.

Speaker: Charles H. Paul | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Robert J. Russell

Drug Master Files: Understanding and Meeting your Regulatory and Processing Responsibilities

This combined Quality Agreement and DMF (Drug Master Files) training will discuss the advantages for suppliers and drug product manufacturers developing these arrangements together.

Speaker: Robert J. Russell | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Robert J. Russell

BREXIT - What's Changing for Life Science Product License Holders-Manufacturers and What you Need to do Right Now

The United Kingdom submitted its' notification on 29 March 2017 to withdraw from the European Union. This means that unless a withdrawal agreement establishes another date, all EU primary and secondary Laws cease to apply to the UK from 30 March 2019 going forward.

Speaker: Robert J. Russell | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Robert J. Russell

3-Hour Virtual Seminar on Japan - Regulatory Filing Requirements and Compliance Processes for Life Sciences

This 3-Hour webinar covers the details of the Regulatory Requirements for a wide-range of Life Science products in Japan: Pharmaceuticals, Biologics, Medical Devices and Combination Products. The syllabus also covers the change in Japan caused by the re-write of the Pharmaceutical Affairs Law [PAL] into the Pharmaceuticals & Medical Device Law [PMDL] and the country's latest update to GMP requirements.

Speaker: Robert J. Russell | View Anytime | Duration: 3 Hours | Price: $340.00 | View Details
Robert J. Russell

Latin America Regulatory Compliance: Current Challenges in Argentina, Brazil and Mexico

The Latin America Regulatory compliance requirement training/webinar will cover topics across the full Life-Cycle of Company & Product licensing in the key markets of Latin America. Written Regulations vs. Skillful Negotiation will be explained across every critical topic. The importance of local resources, Agency meetings and knowing how to navigate the regulatory landscape will accelerate country establishment and successful product licensing.

Speaker: Robert J. Russell | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Peggy Berry

Complaint Handling

The information obtained will enable preparation of effective internal systems for receiving, investigating and responding to product complaints during both the investigational and commercial stages. The webinar will address aspects of the review process, SOP preparation, investigation documentation, and response to complainants.

Speaker: Peggy Berry | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Michael Esposito

Onboarding Employees in a GMP Environment: Best Practices for Foundational Employee Success

The FDA's expectations for training new employees are summed up in 21 CFR 211.25(a), i.e., pharmaceutical professionals require the education, training and experience to complete their job functions. Onboarding new or transferred employees in a Pharmaceutical Good Manufacturing Practices (GMP) environment and ensuring compliance with these requirements create some unique challenges.

Speaker: Michael Esposito | View Anytime | Price: $190.00 | View Details
John N. Zorich

Valid Statistical Rationales for Sample Sizes

This webinar explains the logic behind sample-size choice for several statistical methods that are commonly used in verification or validation efforts, and how to express a valid statistical justification for a chosen sample size.

Speaker: John N. Zorich | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
John N. Zorich

2-Hour Virtual Seminar on Valid Statistical Rationales for Sample Sizes

This webinar explains the logic behind sample-size choice for several statistical methods that are commonly used in verification or validation efforts, and how to express a valid statistical justification for a chosen sample size.

Speaker: John N. Zorich | View Anytime | Duration: 2 Hours | Price: $240.00 | View Details
John N. Zorich

Process Validation: Statistical Justification for Sample Size and the Use of Only 3 Lots

This webinar explains how to choose and justify a sample-size for Lots that are included in Process Validation studies.

Speaker: John N. Zorich | View Anytime | Price: $190.00 | View Details
Wayne Taylor

Medical Devices - Complying With 820.250 Statistical Methods

Learn how to manage Statistics including establishing a policy along with procedures relative to specific areas of applications. Highlighted are statistical techniques for:

Speaker: Wayne Taylor | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Eyal Lerner

The New ISO 13485:2016 and Comparison with 21CFR820 - How to Comply with both in the Same Organization

Many medical devices are distributed in USA and in the European Union (EU). Each market has its own regulatory requirements which mainly focused on its quality management systems (QMS). The two QMS are described in two documents, one by the international ISO standard 13485 and the other by FDA Quality System Regulation (21CFR820).

Speaker: Eyal Lerner | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Thomas Bento

The Value of a Human Factors Program

This webinar will explain the implementation of ISO 62366 and the regulatory expectations discussed in the 2016 FDA Guidance for a compliant human factors/ usability program.

Speaker: Thomas Bento | View Anytime | Price: $190.00 | View Details
Ginette Collazo

Controlling Human Error in the Manufacturing Floor

Human error is known to be the major cause of quality and production losses in many industries. Although it is unlikely that human error will ever be totally eliminated, many human performance problems can be prevented. Human errors start at the design stage. From procedures, training, and workplace environment many variables that affect human behavior CAN be manipulated reducing the likelihood of these occurrences.

Speaker: Ginette Collazo | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Ginette Collazo

Tools for Human Error Reduction

Human error is known to be the major cause of quality and production losses in many industries. Although it is unlikely that human error will ever be totally eliminated, many human performance problems can be prevented. Human errors start at the design stage. From procedures, training, and workplace environment many variables that affect human behavior CAN be manipulated reducing the likelihood of these occurrences.

Speaker: Ginette Collazo | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Ginette Collazo

Supervising a Human Error Free Environment: You can do a Lot More than you Think

Human error is known to be the major cause of quality and production losses in many industries. Although it is unlikely that human error will ever be totally eliminated, many human performance problems can be prevented. Human errors start at the design stage. From procedures, training, supervision, and workplace environment many variables that affect human behavior CAN be manipulated reducing the likelihood of these occurrences.

Speaker: Ginette Collazo | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Michael Abitz

Fishbone Diagramming

Fishbone Diagramming is an analytical approach used to identify and solve problems. Analysis is presented in the Seven Basic Tools of Quality in addition to advanced methods used to increase organizations effectiveness, efficiency and reliability.

Speaker: Michael Abitz | View Anytime | Price: $190.00 | View Details
Michael Abitz

Root Cause Failure Analysis Closed Loop Corrective Action

Root Cause Failure Analysis is an analytical approach used to identify and solve problems. Analysis is presented in the Seven Basic Tools of Quality in addition to advanced methods used to increase organizations effectiveness, efficiency and reliability.

Speaker: Michael Abitz | View Anytime | Price: $190.00 | View Details
Jeff Kasoff

FDA Inspections - Do's and Don'ts

Does the FDA call in advance or just show up at my door? Where do I let the inspector go? Do I give them a tour? What should I let them see? Who should I let them talk to? Are they ever going to leave?

Speaker: Jeff Kasoff | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Jeff Kasoff

Equipment Validation, Tracking, Calibration and Preventive Maintenance

FDA and EU regulations require that firms have a program for the calibration and maintenance of test and measurement equipment. The program must include: intervals, scheduling, specific procedures, limits of accuracy/precision, and remedial action in the event that the equipment does not meet established requirements.

Speaker: Jeff Kasoff | View Anytime | Price: $190.00 | View Details
Jeff Kasoff

How FDA Trains its Investigators to Review CAPA and What you Should do to Prepare

Year after year, CAPA is the subsystem cited most frequently during FDA inspections. During an inspection, FDA personnel will take a great deal of time reviewing your company's CAPA system. What will they look for? This session will discuss techniques used by the FDA to review your CAPA system. The documents used by FDA to train their inspectors to review your CAPA system will be explained, some of which you may not be familiar with.

Speaker: Jeff Kasoff | View Anytime | Price: $190.00 | View Details
John E Lincoln

Device Changes, FDA Changes, and the 510(k)

The majority of medical devices are cleared for marketing in the U.S. by the FDA under the 510(k) process. The FDA holds companies responsible for filing new 510(k)s when one change is major enough to impact safety / effectiveness, or when a series of lesser changes finally reach the "tipping point".

Speaker: John E Lincoln | View Anytime | Price: $190.00 | View Details
John E Lincoln

Verification vs Validation-Product, Process or Equipment and QMS Software

The verification and validation of regulated software is coming under increased scruinty by the U.S. FDA.This webinar will address the use of the FDA, GAMP, 21 CFR Part 11,"Electronic Records"/"Electronic Signatures", IEC 62304, and other applicable industry software validation models, coupled with the ISO 14971/ICH Q9 Product Risk Management models, to plan, structure, run, and document acceptable software validations.

Speaker: John E Lincoln | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
John E Lincoln

Dietary Supplements CGMPS - 21 CFR 111 Compliance

21 CFR part 111 ("the DS CGMP rule") requires persons who manufacture, package, label, or hold a dietary supplement to establish and follow current good manufacturing practice-the CGMPs. This is to ensure the quality of the dietary supplement and to ensure that the dietary supplement is packaged and labeled as specified in the master manufacturing record.

Speaker: John E Lincoln | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
John E Lincoln

Design History Files (DHF), Device Master Records (DMR), Device History Records (DHR), Technical Files , Design Dossiers - The Requirements

It will also consider the European Union's MDD TF/DD requirements, and evaluate the documents' differing purposes / goals, as well as the two different device classification schemes. Required and desirable contents will be discussed.

Speaker: John E Lincoln | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Mike Thomas

OneNote 2016 - Bringing Order to your Digital Chaos

For many people the holy grail of organization is a world where email overload doesn't exist and where all those sticky notes and paper notepads are magically replaced by a digital paperless system. Using OneNote, a free application that you will find in the Microsoft Office suite, this dream can become a reality.

Speaker: Mike Thomas | View Anytime | Price: $190.00 | View Details
Mike Thomas

Outlook - Master your Mailbox - Inbox Hero Inbox Zero

For most business users (and many home users too), Microsoft Outlook has become the standard application for managing emails, calendar appointments and to-dos. With an abundance of features and versions for desktop and mobile, there's really no excuse not to be organized. Or so the theory goes.

Speaker: Mike Thomas | View Anytime | Price: $190.00 | View Details
Mike Thomas

Excel Formulas and Functions 101

Although it is perfectly possible to use Excel without ever creating a formula or using a function if you don't, you're missing out on a huge part of the application's power.

Speaker: Mike Thomas | View Anytime | Price: $190.00 | View Details
Dennis Taylor

Time-Saving Excel Tips, Tricks and 100 Shortcuts

Microsoft Excel has a tremendous amount of capability and features and is filled with shortcuts and methods not always visible to the casual user. Whether it's a keystroke shortcut or a hidden command sequence, such shortcuts can make you much more proficient and productive as you use this powerful and popular software.

Speaker: Dennis Taylor | View Anytime | Price: $190.00 | View Details
Dennis Taylor

Mastering Excel Pivot Tables

PivotTable capabilities are enormous; among its many tools and features.

Speaker: Dennis Taylor | View Anytime | Price: $190.00 | View Details
Teri C. Soli

Water System Mythology: Common False Beliefs for Microbial Control and Monitoring

It is an unfortunate fact that most water systems today have been designed and are operated and controlled using at least some traditional concepts and methods that are downright wrong. So how could such traditions become so ingrained and be so wrong? How could well-intentioned benchmarking be so misguided?

Speaker: Teri C. Soli | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Angela Bazigos

If it Isn't Written Down, then it Didn't Happen: Complying with FDA's Good Documentation Practices

Good documentation practice (commonly abbreviated GDP, recommended to abbreviate as GDocP to distinguish from "good distribution practice" also abbreviated GDP) is a term in the pharmaceutical and medical device industries to describe standards by which documents are created and maintained. In a pharmaceutical or medical device environment documentation needs to meet certain requirements to ensure product quality and product safety.

Speaker: Angela Bazigos | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Angela Bazigos

Audit Trail Generation and Review

This webinar will demystify audit trails and describe the benefits of audit trail for your company. Attendees will learn the tools required to generate compliant audit trails on a domestic and international basis and will answer the questions on how to handle systems without automated audit trails, in a compliant manner.

Speaker: Angela Bazigos | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Charles H. Paul

3-Hour Virtual Seminar on Project Management for Non-Project Managers

This webinar will address those project management critical tasks within each project phase that must be performed flawlessly for effective project execution to occur and will provide the foundation and direction for future study of the subject.

Speaker: Charles H. Paul | View Anytime | Duration: 3 Hours | Price: $340.00 | View Details
Casper Uldriks

FDA's New Import Program for 2018

The FDA and U.S. Customs and Border Protection are using new import requirements. The FDA's import software screening program (PREDICT) and the U.S. Custom's ACE software program require more information from the foreign source(s). FDA's product codes and U.S. Harmonized Tariff Schedule (HTS) link the requirements. The software coding information must be correct. Otherwise, you face costly delays and possibly a refusal of the entry.

Speaker: Casper Uldriks | View Anytime | Price: $190.00 | View Details
Danielle DeLucy

Batch Record Review and Product Release

Most Regulatory Agencies require firms to have written procedures in place to document production and process controls, better known as batch records. Additionally, there must be written procedures for a batch record review process that demonstrate compliance.

Speaker: Danielle DeLucy | View Anytime | Price: $190.00 | View Details
Joe Lynch

Block Chain Transformation: Understanding the Impacts and Applications in the Logistics Industry

The logistics industry is huge, worldwide and critical to our global economy. The industry consists of transportation, warehousing, logistics and technology companies that move goods (physical assets) from producers to consumers.

Speaker: Joe Lynch | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Joe Lynch

Block Chain Made Easy - Introduction and Basics for Non-Techies

Once a block is written to the blockchain it can't be altered by anyone. If somebody tries to introduce a fake transaction into the ledger, he can only do so by adding it to all copies of distributed ledger (which is not possible, as every block is cryptographically linked with previous and next block) else that transaction is spotted and will be removed. Before a record is written to the blockchain, it needs to be verified and this is done by special nodes (computers) called miners.

Speaker: Joe Lynch | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
John N. Zorich

Valid Statistical Rationales for Sample Sizes

This webinar explains the logic behind sample-size choice for several statistical methods that are commonly used in verification or validation efforts, and how to express a valid statistical justification for a chosen sample size.

Speaker: John N. Zorich | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Angela Bazigos

3-Hour Virtual Seminar on Data Integrity - FDA's Latest Thinking

This webinar will give you the tools that you need to ensure that you understand data integrity issues and best practices for ensuring data integrity at your company.

Speaker: Angela Bazigos | View Anytime | Duration: 3 Hours | Price: $340.00 | View Details
Angela Bazigos

Key Factors to Write an Effective Standard Operating Procedure (SOP) and Work Instructions (WIs)

This webinar will instruct the participant on how to write, organize, and maintain SOPs and train personnel in a way that will ensure compliance in a way that is concise, reproducible and easy to follow. It will begin with a strategic view of SOPs in a company and how SOPs can help streamline operations in addition to ensuring regulatory compliance.

Speaker: Angela Bazigos | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
John N. Zorich

Better Alternatives to AQL Sampling Plans for Risk Management in Incoming QC

The pros and cons of the 2 most widely used sampling plans (ANSI Z1.4, and Squeglia's C=0) are examined in detail, focusing especially on the weaknesses of such plans in regards to meeting regulatory requirements. Real-world examples are provided for how using such sampling plans leads to production of non-conforming product.

Speaker: John N. Zorich | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
John N. Zorich

2-Hour Virtual Seminar on Valid Statistical Rationales for Sample Sizes

This webinar explains the logic behind sample-size choice for several statistical methods that are commonly used in verification or validation efforts, and how to express a valid statistical justification for a chosen sample size.

Speaker: John N. Zorich | View Anytime | Duration: 2 Hours | Price: $240.00 | View Details
Karl J Hemmerich

Accelerated Aging Techniques for Medical Device Packaging

Accelerated aging (AA) is testing that uses aggravated conditions of heat, oxygen, sunlight, vibration, chemicals, etc. to speed up the normal aging processes of items. It is used to help determine the long-term effects of expected levels of stress within a shorter time, usually in a laboratory by controlled standard test methods.

Speaker: Karl J Hemmerich | View Anytime | Price: $190.00 | View Details
Dr. Ludwig Huber

FDA's New Enforcement of 21 CFR Part 11

FDA continues to enforce Part 11 through its new Part 11 inspection and enforcement program. Just in the last 3 years, FDA issued more than 30 warning letters with Part 11 violations. Citations are related to inadequate integrity, security and availability of electronic records but also related to validation of software and computer systems. There are many questions about the program, e.g., what inspectors are looking at what are major findings.

Speaker: Dr. Ludwig Huber | View Anytime | Duration: 75 Minutes | Price: $190.00 | View Details
Dr. Ludwig Huber

Validation of Analytical Methods and Procedures

Analytical methods should be validated to ensure reliability, consistency and accuracy of analytical data. Method validation has been a requirement of FDA and international regulations and accreditation standards such as ISO 17025 since many years and new official guidelines have been published by FDA, EMA and USP in the last 4 years. Most often the theory is well understood but there are many questions when validation experiments are designed, conducted, and documented.

Speaker: Dr. Ludwig Huber | View Anytime | Duration: 75 Minutes | Price: $190.00 | View Details
Jerry Lanese

Analytical Method Validation

An analytical method is a process. The FDA process validation guidance applies to test methods, like all other processes in the pharmaceutical industry. Therefore, the laboratory or laboratories must demonstrate that a test method performs as intended through the method lifecycle.

Speaker: Jerry Lanese | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Dr. Shuguang Huang

2-Hour Virtual Seminar - Biomarker Development and Validation - A Statistical Perspective

Biomarker is very critical in pre-clinical drug discovery, clinical translational research, diagnostic product (including companion diagnostic) development. This webinar will focus on three areas:

Speaker: Dr. Shuguang Huang | View Anytime | Duration: 2 Hours | Price: $240.00 | View Details
Dr. Ludwig Huber

Understanding the USP Chapter 1224 for Transfer of Analytical Methods

When validated methods are transferred between laboratories and sites, their validated state should be maintained to ensure the same reliable results in the receiving laboratory.

Speaker: Dr. Ludwig Huber | View Anytime | Duration: 75 Minutes | Price: $190.00 | View Details
Dr. Ludwig Huber

Validation and Use of Excel® Spreadsheets in FDA Regulated Environments

Excel® Applications are widely used in laboratories, offices and manufacturing e.g., for data capture, data manipulation and report generation.

Speaker: Dr. Ludwig Huber | View Anytime | Duration: 75 Minutes | Price: $190.00 | View Details
Dennis Taylor

Excel Formulas and Functions

Built in to Excel are over 450 functions - a potent set of power tools that simplifies certain kinds of formulas and gives you a huge number of computational possibilities. Many Excel functions provide extended analytical capabilities and open the door to more efficient use of Excel.

Speaker: Dennis Taylor | View Anytime | Price: $190.00 | View Details
Dennis Taylor

2-Hour Virtual Seminar on Mastering Excel Pivot Tables

You will learn the following in this webinar, The quickest and best ways to create PivotTables and Pivot Charts, including these capabilities:

Speaker: Dennis Taylor | View Anytime | Duration: 2 Hours | Price: $240.00 | View Details
Laura Brown

EU General Data Protection Regulation (GDPR): Compliance for Drug development and Clinical Trials?

The General Data Protection Regulation (GDPR) is new legislation that had come into force on 25th of May 2018 brings substantial changes to the rules around personal data and its use. While it aims at building on existing Data Protection legislation, it represents a significant change for organisations that hold and process personal data particularly for clinical trial data and drug development.

Speaker: Laura Brown | View Anytime | Price: $190.00 | View Details
Dennis Taylor

Time-Saving Excel Tips, Tricks and 100 Shortcuts

Microsoft Excel has a tremendous amount of capability and features and is filled with shortcuts and methods not always visible to the casual user. Whether it's a keystroke shortcut or a hidden command sequence, such shortcuts can make you much more proficient and productive as you use this powerful and popular software.

Speaker: Dennis Taylor | View Anytime | Price: $190.00 | View Details
Dennis Taylor

Mastering Excel Pivot Tables

PivotTable capabilities are enormous; among its many tools and features.

Speaker: Dennis Taylor | View Anytime | Price: $190.00 | View Details
Laura Brown

How to Write SOPs which are Compliant for Inspections for a GXP Compliance

This webinar will help Sponsors, CROs in the US, EU and internationally,understand how to write SOPs to comply with inspection requirements.

Speaker: Laura Brown | View Anytime | Price: $190.00 | View Details
John N. Zorich

Process Validation: Statistical Justification for Sample Size and the Use of Only 3 Lots

This webinar explains how to choose and justify a sample-size for Lots that are included in Process Validation studies.

Speaker: John N. Zorich | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
John E Lincoln

3-Hour Virtual Seminar on Master Validation Plan - The Unwritten Requirements

FDA Warning Letters and recent high-profile recalls indicate major cGMP deficiencies in many companies. One major failing is lack of sufficient or targeted risk-based company-wide V&V planning. Starting with a Master Validation Plan, evaluating its elements against ISO 14971 hazard analysis / risk management, allows development of meaningful product validations. The roles of different V&V protocols.

Speaker: John E Lincoln | View Anytime | Duration: 3 Hours | Price: $340.00 | View Details
John E Lincoln

3-Hour Virtual Seminar on DHF, DMR, DHR, TF , Design Dossiers - The Requirements

This webinar will examine the existing and proposed requirements for the U.S. FDA's DHF, 21 CFR 820.30 and now ISO 13485:2016 7.3 including its derivative documents, the DMR and DHR. It will consider the European Union's MDD TF/DD and its transition to the EU MDR requirements, and evaluate the documents' differing purposes / goals, as well as the two different device classification schemes. Required and desirable contents will be discussed.

Speaker: John E Lincoln | View Anytime | Duration: 3 Hours | Price: $340.00 | View Details
Wayne Taylor

Validation Sampling Plans for Process Validation, Design Verification and CAPA Effectiveness Checks

This course is designed to help you select sampling sizes and acceptance criteria for one-time studies like process validation, design verification, component qualifications and CAPA effectiveness checks including:

Speaker: Wayne Taylor | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Wayne Taylor

Medical Devices - Complying With 820.250 Statistical Methods

Learn how to manage Statistics including establishing a policy along with procedures relative to specific areas of applications. Highlighted are statistical techniques for:

Speaker: Wayne Taylor | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Angela Bazigos

3-Hour Virtual Seminar on Data Integrity - FDA's Latest Thinking

This webinar will give you the tools that you need to ensure that you understand data integrity issues and best practices for ensuring data integrity at your company.

Speaker: Angela Bazigos | View Anytime | Duration: 3 Hours | Price: $340.00 | View Details
Angela Bazigos

How to Implement Lean Documents and Lean Document Control to Cut Costs, while Maintaining Compliance with Regulatory Authority Requirements

This webinar will show you how to implement lean documents and lean document control to cut costs, while maintaining compliance with regulatory authority requirements.

Speaker: Angela Bazigos | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Angela Bazigos

European Data Protection Regulation - 2018 Implementation

On 4 May 2016, the official texts of the Regulation and the Directive have been published in the EU Official Journal in all the official languages. While the Regulation will enter into force on 24 May 2016, it shall apply from 25 May 2018. The Directive enters into force on 5 May 2016 and EU Member States have to transpose it into their national law by 6 May 2018.

Speaker: Angela Bazigos | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Emil W Ciurczak

Control-Analysis Instrumentation used in PAT and Continuous Manufacturing

We will briefly discuss how to go from minimum sampling, sending them to a lab, and waiting for results, to real-time monitoring, taking huge numbers of readings, and how to understand and apply these data to control and improve new and existing products.

Speaker: Emil W Ciurczak | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Dr. Afsaneh Motamed Khorasani

Good Documentation and Record Keeping Best Practices (FDA & EMA)

Good documentation Practices (GDP) is an essential factor that needs to be closely followed by the personnel in any regulated environment as a process for a successful project completion including observations of unanticipated responses that are required to be accurately recorded and verified.

Speaker: Dr. Afsaneh Motamed Khorasani | View Anytime | Price: $190.00 | View Details
Dr. Ludwig Huber

3-Hour Virtual Seminar on Validation, Verification and Transfer of Analytical Methods - Implementing Guidelines from FDA-EMA, USP and ICH

The 3-hour virtual seminar will give attendees the background to understand the requirements and even more importantly it will focus on strategies and provide tools to implement even most critical requirements.

Speaker: Dr. Ludwig Huber | View Anytime | Duration: 3 Hours | Price: $340.00 | View Details
Danielle DeLucy

Handling OOS Test Results and Completing Robust Investigations

This training program will describe when a full investigation should be triggered and the frequency for re-testing and re-sampling. Attendees will also learn how to implement corrective and preventive action plans (CAPA).

Speaker: Danielle DeLucy | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Danielle DeLucy

Implementation and Management of GMP Data Integrity

Data integrity is the assurance that data records are accurate, complete, intact and maintained within their original context, including their relationship to other data records. This definition applies to data recorded in electronic and paper formats or a hybrid of both.

Speaker: Danielle DeLucy | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Dr. Afsaneh Motamed Khorasani

Good Documentation Guideline (Chapter 1029 USP)

Good Documentation Practices (GDP) is a critical and essential part of a regulated environment (pharmaceutical and medical device manufacturing, R&D, laboratories and clinical trials). Compliance with GDP ensures an auditable account of work. It ensures integrity and control of documents and is a key requirement for a developed quality system.

Speaker: Dr. Afsaneh Motamed Khorasani | View Anytime | Price: $190.00 | View Details
Susanne Manz

Risk Management Techniques for Medical Devices

Product Risk Management is a critical aspect of ensuring medical devices are safe and effective for intended uses. This course will help you understand the regulatory requirements, including ISO14971, and how to create processes and procedures to implement them.

Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Susanne Manz

Root Cause Analysis for CAPA - Myths, Challenges, and Best Practices

This webinar will help you understand the critical ingredients for conducting an effective root cause analysis. You will learn about FDA expectations, tools and techniques, and tips for conducting and documenting root cause analysis. We will discuss the myths, challenges, and best practices for this critical process. We'll also cover the essentials of doing a failure investigation.

Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Susanne Manz

Essentials of Validation - IQ, OQ, PQ

Validation is an important element of the Quality System Regulations and ISO13485. This course will cover the requirements the essentials of validation. You'll learn about what processes needed to be validated and what steps you need to take to validate processes. You'll learn the essentials of validation planning, protocol writing, and change management

Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Susanne Manz

Secrets to Writing Effective SOPs for Medical Device QMS

Standard Operating Procedures (SOPs) are a critical ingredient in an effective and efficient Quality Management System. SOPs are typically one of the first things an investigator asks for in an inspection. Well written SOPs send a message to the FDA and Notified Bodies that your QMS is complete, accurate, and followed. More importantly, well written SOPs ensure that your personnel can consistently and accurately follow your processes resulting in correct outcomes and quality work.

Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Susanne Manz

Death By CAPA - Does your CAPA Program Need a CAPA?

This webinar will help you establish an efficient and effective CAPA (Corrective and Preventive Action) process leading to improved quality and compliance for your company. You'll learn how to streamline and monitor your process to ensure compliance and improved performance. If your CAPA process needs a CAPA, this webinar is for you. We will discuss requirements, the myths, and the challenges of managing CAPAs so you can avoid common problems and pitfalls.

Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Robert J. Russell

BREXIT - What's Changing for Life Science Product License Holders-Manufacturers and What you Need to do Right Now

The United Kingdom submitted its' notification on 29 March 2017 to withdraw from the European Union. This means that unless a withdrawal agreement establishes another date, all EU primary and secondary Laws cease to apply to the UK from 30 March 2019 going forward.

Speaker: Robert J. Russell | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Angela Bazigos

3-Hour Virtual Seminar on Excel Spreadsheet Validation for FDA 21 CFR Part 11

Spreadsheets such as Excel, are available for creating a wide range of end user applications, including widespread use in the laboratory, creating customized statistical analyses, the creation of local databases, data mining, and multivariate analysis. These may be used for GxP regulated activities, and they present particular compliance challenges, as Excel and other spreadsheets are not originally designed for the regulated environment.

Speaker: Angela Bazigos | View Anytime | Duration: 3 Hours | Price: $340.00 | View Details
Robert J. Russell

EU Medical Device Regulation (MDR) - Updated CE Marking Process & ISO 13485:2016 Expectations

This EU Medical Device Regulation (MDR) 90-minute webinar will discuss the recently developed regulation and its impact on the future compliance and registration of medical devices in the EU. It includes specific insights from direct involvement and work within the EU and the Commission's major improvement objectives to their system today. Areas of change between the prior Medical Device Directive (MDD) and the MDR will be discussed as well as expectations for how to implement ISO-13485:2016.

Speaker: Robert J. Russell | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Ginette Collazo

3-Hour Virtual Seminar on Human Error Reduction in the Manufacturing Floor

Human error is known to be the primary cause of quality and production losses in many industries. Although it is unlikely that human error will ever be eliminated, many human performance problems can be prevented.Human errors start at the design stage. From procedures, training, and workplace environment many variables that affect human behavior CAN be manipulated reducing the likelihood of these occurrences.

Speaker: Ginette Collazo | View Anytime | Duration: 3 Hours | Price: $340.00 | View Details
Angela Bazigos

Key Factors to Write an Effective Standard Operating Procedure (SOP) and Work Instructions (WIs)

This webinar will instruct the participant on how to write, organize, and maintain SOPs and train personnel in a way that will ensure compliance in a way that is concise, reproducible and easy to follow. It will begin with a strategic view of SOPs in a company and how SOPs can help streamline operations in addition to ensuring regulatory compliance. This will be followed by explanation on how to get from regulations to the SOP. Finally, Best Practices for creating, implementing and maintaining SOPs using a risk based approach and getting SOPs ready for inspection will be presented.

Speaker: Angela Bazigos | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
John N. Zorich

2-Hour Virtual Seminar on Valid Statistical Rationales for Sample Sizes

This webinar explains the logic behind sample-size choice for several statistical methods that are commonly used in verification or validation efforts, and how to express a valid statistical justification for a chosen sample size.

Speaker: John N. Zorich | View Anytime | Duration: 2 Hours | Price: $240.00 | View Details
Vanessa Lopez

2-Hour Virtual Seminar on Supplier and Service Provider Controls: FDA Expectations

This webinar will provide the regulatory requirements (US) of 21 CFR Section 820.50 (Purchasing Control) for the Medical Device industry and provide you with examples. It will furnish details on what should your Purchasing/Supplier Control management system address.

Speaker: Vanessa Lopez | View Anytime | Duration: 2 Hours | Price: $240.00 | View Details
Tim Lombardo

Game of Zones: a Practical Application of FDA Guidance Document - Control of Listeria Monocytogenes in Ready-to-Eat Foods

This webinar will break down recommendations included in the guidance document and provide some practical solutions to each.

Speaker: Tim Lombardo | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Danielle DeLucy

Batch Record Review and Product Release

Most Regulatory Agencies require firms to have written procedures in place to document production and process controls, better known as batch records. Additionally, there must be written procedures for a batch record review process that demonstrate compliance.

Speaker: Danielle DeLucy | View Anytime | Price: $190.00 | View Details
Danielle DeLucy

Handling OOS Test Results and Completing Robust Investigations

This webinar will review the regulatory requirements for investigating an OOS Investigation. The responsibilities of the analyst, the supervisor and QA will be discussed. A detailed flow chart will be used to help the attendees clearly understand the steps and the order in which they are to be performed. The structure of an Investigation report which properly documents the investigation will be discussed.

Speaker: Danielle DeLucy | View Anytime | Price: $190.00 | View Details
Derk Yntema

3-Hour Virtual Seminar on GDPR - European Privacy Regulation what and how

The GDPR (General Data Protection Regulation) compels companies that process Personally Identifiable Information (PII) of European citizens to demonstrate their insight in all PII processing in their business. After assessment by a Data Protection Officer (DPO), they should implement appropriate organizational and technical controls.

Speaker: Derk Yntema | View Anytime | Duration: 3 Hours | Price: $340.00 | View Details
Carolyn Troiano

FDA's New Draft Guidance on Software and Device Changes and the 510(k)

A 510(k) is a premarket submission made to FDA to demonstrate that the device to be marketed is at least as safe and effective, that is, substantially equivalent, to a legally marketed device (21 CFR 807.92(a)(3)) that is not subject to PMA.

Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Carolyn Troiano

3-Hour Virtual Seminar Computer System Validation (CSV) for FDA-Regulated Computers

FDA requires that all computer systems used to produce, manage and report on GxP (GMP, GLC, GCP) related products be validated and maintained in accordance with specific rules. This webinar will leave you with the information needed to plan, execute and document a computer system validation effort that meets FDA compliance standards.

Speaker: Carolyn Troiano | View Anytime | Duration: 3 Hours | Price: $340.00 | View Details
Dr. Ludwig Huber

3-Hour Virtual Seminar on FDA's New Enforcement of 21 CFR Part 11

FDA continues to enforce Part 11 through its ongoing Part 11 inspection and enforcement program. Just in the last 3 years FDA issued more than 30 warning letters with Part 11 related observations. Citations are related to inadequate integrity, security and availability of electronic records, including data manipulation.

Speaker: Dr. Ludwig Huber | View Anytime | Duration: 3 Hours | Price: $340.00 | View Details
Yingying Liu

Pharmaceutical Drug Registration in China

Bringing pharmaceutical products to market in China has become much easier for foreign companies. The Chinese FDA (CFDA), now renamed as CNDA, recently made a series of significant changes to the marketing authorisation regulations by issuing a large number of guidelines and opinions (in Chinese).

Speaker: Yingying Liu | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
John N. Zorich

Valid Statistical Rationales for Sample Sizes

This webinar explains the logic behind sample-size choice for several statistical methods that are commonly used in verification or validation efforts, and how to express a valid statistical justification for a chosen sample size.

Speaker: John N. Zorich | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
John N. Zorich

Better Alternatives to AQL Sampling Plans for Risk Management in Incoming QC

The pros and cons of the 2 most widely used sampling plans (ANSI Z1.4, and Squeglia's C=0) are examined in detail, focusing especially on the weaknesses of such plans in regards to meeting regulatory requirements. Real-world examples are provided for how using such sampling plans leads to production of non-conforming product.

Speaker: John N. Zorich | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Dennis Taylor

2-Hour Virtual Seminar on Mastering Excel Pivot Tables

You will learn the following in this webinar, The quickest and best ways to create PivotTables and Pivot Charts, including these capabilities: The following subjects will be covered in detail:

Speaker: Dennis Taylor | View Anytime | Duration: 2 Hours | Price: $240.00 | View Details
Angela Bazigos

3-Hour Virtual Seminar on Writing Effective SOPs

Every biopharmaceutical company has SOPs, and new staff members are told that the company "has to have them" and that each employee "has to follow them". But why do there have to be SOPs and why must we follow them as written? And how can we do this effectively?

Speaker: Angela Bazigos | View Anytime | Duration: 3 Hours | Price: $340.00 | View Details
Dr. Ludwig Huber

FDA's New Enforcement of 21 CFR Part 11

FDA continues to enforce Part 11 through its new Part 11 inspection and enforcement program. Just in the last 3 years, FDA issued more than 30 warning letters with Part 11 violations. Citations are related to inadequate integrity, security and availability of electronic records but also related to validation of software and computer systems. There are many questions about the program, e.g., what inspectors are looking at what are major findings.

Speaker: Dr. Ludwig Huber | View Anytime | Duration: 75 Minutes | Price: $190.00 | View Details
Thomas Bento

Validation of Non-Product Software

This course will teach how to comply to 21 CFR Part 820.70(i) and effectively implement a software validation program for medical devices, meeting the FDA requirements and produce a safe product. We will explain the role of Risk Management in Non-Product Validation. How software requirements are used in validation will be described.

Speaker: Thomas Bento | View Anytime | Price: $190.00 | View Details
Charles H. Paul

FDA Best Audit Behavior Practices - Do's and Don'ts

This webinar will begin by discussing and emphasizing the importance of truthfulness to the process - truthfulness in performing the job on a daily basis, truthfulness in completing the regulatory documentation that is so much a part of our regulatory lives, and finally in the context of this webinar, truthfulness when interacting with FDA inspectors.

Speaker: Charles H. Paul | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Charles H. Paul

Project Management for Non-Project Managers

This webinar will address those project management critical tasks within each project phase that must be performed flawlessly for effective project execution to occur and will provide the foundation and direction for future study of the subject.

Speaker: Charles H. Paul | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Dr. Ludwig Huber

Understanding the USP Chapter 1224 for Transfer of Analytical Methods

When validated methods are transferred between laboratories and sites, their validated state should be maintained to ensure the same reliable results in the receiving laboratory.

Speaker: Dr. Ludwig Huber | View Anytime | Duration: 75 Minutes | Price: $190.00 | View Details
Robert J. Russell

3-Hour Virtual Seminar on Japan - Regulatory Filing Requirements and Compliance Processes for Life Sciences

This 3-Hour webinar covers the details of the Regulatory Requirements for a wide-range of Life Science products in Japan: Pharmaceuticals, Biologics, Medical Devices and Combination Products. The syllabus also covers the change in Japan caused by the re-write of the Pharmaceutical Affairs Law [PAL] into the Pharmaceuticals & Medical Device Law [PMDL] and the country's latest update to GMP requirements.

Speaker: Robert J. Russell | View Anytime | Duration: 3 Hours | Price: $340.00 | View Details
Charles H. Paul

3-Hour Virtual Seminar on Project Management for Non-Project Managers

This webinar will address those project management critical tasks within each project phase that must be performed flawlessly for effective project execution to occur and will provide the foundation and direction for future study of the subject.

Speaker: Charles H. Paul | View Anytime | Price: $340.00 | View Details
Charles H. Paul

Project Management for Non-Project Managers - Building the Work Breakdown Structure

The single most important aspect of any project is the defining of all the tasks that must be performed to accomplish the project's objectives.This definition is called the work breakdown structure.

Speaker: Charles H. Paul | View Anytime | Price: $190.00 | View Details
Eyal Lerner

The New ISO 13485:2016 and Comparison with 21CFR820 - How to Comply with both in the Same Organization

Many medical devices are distributed in USA and in the European Union (EU). Each market has its own regulatory requirements which mainly focused on its quality management systems (QMS). The two QMS are described in two documents, one by the international ISO standard 13485 and the other by FDA Quality System Regulation (21CFR820).

Speaker: Eyal Lerner | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Casper Uldriks

3-Hour Virtual Seminar: FDA Imports Require Precision in 2018

Importing FDA regulated products requires careful planning before you even start. Registration, product compliance, record and data submission must be exactly correct, or else, FDA's entry requirements with detain your product. Some mistakes are common, others reflect a lack of understanding of how FDA and Customs and Border Protection (CBP) operate a joint program.

Speaker: Casper Uldriks | View Anytime | Duration: 3 hours | Price: $340.00 | View Details
Casper Uldriks

FDA's New Import Program for 2018

The FDA and U.S. Customs and Border Protection are using new import requirements. The FDA's import software screening program (PREDICT) and the U.S. Custom's ACE software program require more information from the foreign source(s). FDA's product codes and U.S. Harmonized Tariff Schedule (HTS) link the requirements. The software coding information must be correct. Otherwise, you face costly delays and possibly a refusal of the entry.

Speaker: Casper Uldriks | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Teri C. Soli

Water System Biofilm Control and Microbial Monitoring Myths

It is an unfortunate fact that most water systems today have been designed and are operated and controlled using at least some traditional concepts and methods that are downright wrong. So how could such traditions become so ingrained and be so wrong? How could well-intentioned benchmarking be so misguided?

Speaker: Teri C. Soli | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Ginette Collazo

Controlling Human Error in the Manufacturing Floor

Human error is known to be the major cause of quality and production losses in many industries. Although it is unlikely that human error will ever be totally eliminated, many human performance problems can be prevented. Human errors start at the design stage. From procedures, training, and workplace environment many variables that affect human behavior CAN be manipulated reducing the likelihood of these occurrences.

Speaker: Ginette Collazo | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Dr. Ludwig Huber

Understanding and Implementing USP 1058 Analytical Instrument Qualification

Analytical instruments should be qualified to demonstrate suitability for the intended use. Despite the fact that instrument qualification is nothing new and companies spend a lot of time, it is a frequently cited deviation in FDA inspectional observations and warning letters.

Speaker: Dr. Ludwig Huber | View Anytime | Duration: 75 Minutes | Price: $190.00 | View Details
Dennis Taylor

Mastering Excel Pivot Tables

PivotTable capabilities are enormous; among its many tools and features.

Speaker: Dennis Taylor | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Ginette Collazo

Tools for Human Error Reduction

Human error is known to be the major cause of quality and production losses in many industries. Although it is unlikely that human error will ever be totally eliminated, many human performance problems can be prevented. Human errors start at the design stage. From procedures, training, and workplace environment many variables that affect human behavior CAN be manipulated reducing the likelihood of these occurrences.

Speaker: Ginette Collazo | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Laura Brown

EU General Data Protection Regulation (GDPR): Compliance for Clinical Trials - are you Ready for Implementation for May 25th 2018?

Attain an understanding of the General Data Protection Regulation (GDPR).Be able to understand the key of the main tenets of GDPR which impact on clinical trials.

Speaker: Laura Brown | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Lynn Fountain

COSO New Fraud Principals

This course delves further into the expectations of COSO Principle Eight.We discuss and evaluate the COSO anti-fraud guide released in September 2016 and evaluate how the Fraud principles relate to the COSO 2013 principles.We also examine actions that organizations, management, and employees should be aware of in relationship to fraud.

Speaker: Lynn Fountain | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Jerry Lanese

Laboratory Investigation of Out-of-Specification Results

The objective of this webinar is to develop an understanding of how a compliant laboratory handles the investigation of out-of-specification (OOS) test results and how the laboratory interfaces with other units through the laboratory investigation process. The discussion will be based on the FDA guidance on handling OOS laboratory results.

Speaker: Jerry Lanese | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Derk Yntema

GDPR - European Privacy Regulation what and how

The GDPR (General Data Protection Regulation) compels companies that process Personally Identifiable Information (PII) of European citizens to demonstrate their insight in all PII processing going on in their business. After assessment by a Data Protection Officer (DPO), they should implement appropriate organizational and technical controls.

Speaker: Derk Yntema | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Angela Bazigos

Audit Trail Generation and Review

This webinar will demystify audit trails and describe the benefits of audit trail for your company. Attendees will the tools required to generate compliant audit trails on a domestic and international basis and will answer the questions on how to handle systems without automated audit trails, in a compliant manner.

Speaker: Angela Bazigos | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Robert J. Russell

Latin America Regulatory Compliance: Current Challenges in Argentina, Brazil and Mexico

The Latin America Regulatory compliance requirement training/webinar will cover topics across the full Life-Cycle of Company & Product licensing in the key markets of Latin America. Written Regulations vs. Skillful Negotiation will be explained across every critical topic. The importance of local resources, Agency meetings and knowing how to navigate the regulatory landscape will accelerate country establishment and successful product licensing.

Speaker: Robert J. Russell | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Michael Abitz

Root Cause Failure Analysis Closed Loop Corrective Action

Root Cause Failure Analysis is an analytical approach used to identify and solve problems. Analysis is presented in the Seven Basic Tools of Quality in addition to advanced methods used to increase organizations effectiveness, efficiency and reliability.

Speaker: Michael Abitz | View Anytime | Price: $190.00 | View Details
Michael Abitz

Fishbone Diagramming

Fishbone Diagramming is an analytical approach used to identify and solve problems. Analysis is presented in the Seven Basic Tools of Quality in addition to advanced methods used to increase organizations effectiveness, efficiency and reliability.

Speaker: Michael Abitz | View Anytime | Price: $190.00 | View Details
John N. Zorich

Valid Statistical Rationales for Sample Sizes

This webinar explains the logic behind sample-size choice for several statistical methods that are commonly used in verification or validation efforts, and how to express a valid statistical justification for a chosen sample size.

Speaker: John N. Zorich | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Teri C. Soli

Water System Mythology: Common False Beliefs for Microbial Control and Monitoring

It is an unfortunate fact that most water systems today have been designed and are operated and controlled using at least some traditional concepts and methods that are downright wrong. So how could such traditions become so ingrained and be so wrong? How could well-intentioned benchmarking be so misguided?

Speaker: Teri C. Soli | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
John C. Fetzer

Analytical Method Validation Under Good Laboratory Practices - GLPs

If you do any work that will be reported to the US Food and Drug Administration (FDA), Environmental Protection Agency (EPA), or Occupational Safety and Health Administration (OSHA), your work must be done under GLP. All methods must be validated, the proof that they do what is claimed. Common criteria are accuracy, precision, linearity, range, and several more.

Speaker: John C. Fetzer | View Anytime | Price: $190.00 | View Details
Susanne Manz

3-Hour Virtual Seminar on CAPA for Medical Devices

CAPA is the foundation of an effective Quality Management System. Yet, many companies suffer from Death by CAPA - a slow, bureaucratic, and ineffective CAPA process. Not only do they fail to achieve necessary improvements, they waste precious time and resources. This 3-hour webinar will help you establish an efficient and effective CAPA (Corrective and Preventive Action) process leading to improved quality and compliance for your company. Learn how to avoid common problems and establish an efficient and effective CAPA process leading to improved quality and compliance for your company.

Speaker: Susanne Manz | View Anytime | Duration: 3 Hours | Price: $340.00 | View Details
Susanne Manz

3-Hour Virtual Seminar on Design Controls for Medical Devices

Design Control is considered a critical process by the FDA. Yet is still a common source of 483 and Warning Letter observations. Most importantly, Design Control is critical to product quality, ensuring safe and effective products for your customers.

Speaker: Susanne Manz | View Anytime | Duration: 3 Hours | Price: $340.00 | View Details
Robert Michalik

FDA - Legal Writing Skills that Result in Effective Regulatory Submissions

Law school prepares attorneys to condense complex sets of facts into concise, persuasive arguments that achieve client objectives. These writing skills are even more critical when drafting responses and applications to FDA that are predicated on complex scientific and technical arguments.

Speaker: Robert Michalik | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
John N. Zorich

3-Hour Virtual Seminar on Statistical Process Control (SPC): A Detailed Introduction

Manufacturing involves an attempt to produce items that as closely as possible meet design specifications (e.g., size, strength, etc.). However, all production processes exhibit variation that is, no two items are identical. What method can be used to reduce such variation? The classic and still most widely used method is called SPC or "statistical process control".

Speaker: John N. Zorich | View Anytime | Duration: 3 Hours | Price: $340.00 | View Details
Danielle DeLucy

Handling OOS Test Results and Completing Robust Investigations

This webinar will review the regulatory requirements for investigating an OOS Investigation. The responsibilities of the analyst, the supervisor and QA will be discussed. A detailed flow chart will be used to help the attendees clearly understand the steps and the order in which they are to be performed. The structure of an Investigation report which properly documents the investigation will be discussed.

Speaker: Danielle DeLucy | View Anytime | Price: $190.00 | View Details
Karl J Hemmerich

Accelerated Aging Techniques for Medical Device Packaging

Accelerated aging (AA) is testing that uses aggravated conditions of heat, oxygen, sunlight, vibration, chemicals, etc. to speed up the normal aging processes of items. It is used to help determine the long-term effects of expected levels of stress within a shorter time, usually in a laboratory by controlled standard test methods.

Speaker: Karl J Hemmerich | View Anytime | Price: $190.00 | View Details
Angela Bazigos

What do the FDA, EMA and PMDA Look for When Conducting cGMP Regulatory Inspections

This webinar will cover the key areas of how ICH Q7 was established, it's goals and objectives, expectations of the healthcare authorities involved and practical differences that you will experience in a GMP inspection of a facility by FDA, an EU Competent Authority or PMDA. After this event, you will be fully prepared for cGMP regulatory inspections in those countries.

Speaker: Angela Bazigos | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Angela Bazigos

3-Hour Virtual Seminar on Deciding When to Submit a 510(k) for a Change to an Existing Device

This presentation, will aid manufacturers of medical devices who intend to modify a 510(k)-cleared device or a preamendments device subject to 510(k) (i.e., "existing devices") during the process of deciding whether the modification exceeds the regulatory threshold of 21 CFR 807.81(a)(3) for submission and clearance of a new 510(k).

Speaker: Angela Bazigos | View Anytime | Duration: 3 Hours | Price: $340.00 | View Details
Angela Bazigos

Excel Spreadsheets for 21 CFR 11 Compliance

Spreadsheet Applications such as MS Excel are frequently used in 21 CFR 11 compliant environments, but they were not specifically designed for regulated environments and their development is not optimized for 21 CFR 11 compliance. However, the FDA expects that spreadsheets be compliant and lack of compliance can result in a warning letter. Consequently, validation of Excel Spreadsheet Applications is required as part of a 21 CFR 11 compliant environment.

Speaker: Angela Bazigos | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Vanessa Lopez

Best Practices to Prepare for and Manage FDA Inspections

Preparing for and managing an FDA Inspection; the actual flow of company activities and roles; the inspection process, and the impact of non-compliance to FDA requirements on the medical devices/pharmaceutical firms, competiveness in the market, revenue, distribution, reliability status, and partnerships with suppliers, among others. It will also provides the challenges from the results of an inspection, in preparing and managing an inspection, and the benefits of successful results from an FDA inspection.

Speaker: Vanessa Lopez | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Charles H. Paul

3-Hour Virtual Seminar on Project Management for Non-Project Managers

This webinar will address those project management critical tasks within each project phase that must be performed flawlessly for effective project execution to occur and will provide the foundation and direction for future study of the subject.

Speaker: Charles H. Paul | View Anytime | Duration: 3 Hours | Price: $340.00 | View Details
Mike Thomas

3-Hour Virtual Seminar on Mastering Excel Formulas and Functions

An Excel formula is an equation or calculation that is stored in a worksheet cell. A formula enables you to perform simple or complex calculations on numbers. So think of any scenario that involves addition, subtraction, division or multiplication and that's where you'd use a formula.

Speaker: Mike Thomas | View Anytime | Duration: 3 Hours | Price: $340.00 | View Details
Susanne Manz

Preparing for an FDA Inspection - What you Need to Know

Although an effective Quality System should always be inspection ready, many medical device companies make basic mistakes during inspections leading to 483s and even warning letters. This webinar can help you manage inspections efficiently and effectively.

Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Charles H. Paul

Project Management for Non-Project Managers

This webinar will address those project management critical tasks within each project phase that must be performed flawlessly for effective project execution to occur and will provide the foundation and direction for future study of the subject.

Speaker: Charles H. Paul | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Dr. Ludwig Huber

Validation and Use of Excel® Spreadsheets in FDA Regulated Environments

Excel® Applications are widely used in laboratories, offices and manufacturing e.g., for data capture, data manipulation and report generation.

Speaker: Dr. Ludwig Huber | View Anytime | Duration: 75 Minutes | Price: $190.00 | View Details
Dr. Ludwig Huber

3-Hour Virtual Seminar on FDA's New Enforcement of 21 CFR Part 11

FDA continues to enforce Part 11 through its ongoing Part 11 inspection and enforcement program. Just in the last 3 years FDA issued more than 30 warning letters with Part 11 related observations. Citations are related to inadequate integrity, security and availability of electronic records, including data manipulation.

Speaker: Dr. Ludwig Huber | View Anytime | Duration: 3 Hours | Price: $340.00 | View Details
John E Lincoln

3-Hour Virtual Seminar on DHF, DMR, DHR, TF , Design Dossiers - The Requirements

This webinar will examine the existing and proposed requiements for the U.S. FDA's DHF, 21 CFR 820.30 and now ISO 13485:2016 7.3 including its derivitive documents, the DMR and DHR. It will consider the European Union's MDD TF/DD and its transition to the EU MDR requirements, and evaluate the documents' differing purposes / goals, as well as the two different device classification schemes. Required and desirable contents will be discussed.

Speaker: John E Lincoln | View Anytime | Duration: 3 Hours | Price: $340.00 | View Details
John E Lincoln

3-Hour Virtual Seminar on Master Validation Plan - The Unwritten Requirements

FDA Warning Letters and recent high-profile recalls indicate major cGMP deficiencies in many companies. One major failing is lack of sufficient or targeted risk-based company-wide V&V planning. Starting with a Master Validation Plan, evaluating its elements against ISO 14971 hazard analysis / risk management, allows development of meaningful product validations. The roles of different V&V protocols.

Speaker: John E Lincoln | View Anytime | Duration: 3 Hours | Price: $340.00 | View Details
Steven S. Kuwahara

Auditing Analytical Laboratories for FDA Compliance

Auditing analytical laboratories can be complex because of the preparation that is often required. All of the GMP rules do not apply to the laboratory; while there may be additional requirements depending upon the type of testing that is being conducted. In many cases, the laboratory itself may not understand what regulations apply to the work that is being conducted.

Speaker: Steven S. Kuwahara | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Robert J. Russell

3-Hour Virtual Seminar on Japan - Regulatory Filing Requirements and Compliance Processes for Life Sciences

This 3-hour webinar covers the details of the Regulatory Requirements for a wide-range of Life Science products in Japan: Pharmaceuticals, Biologics, Medical Devices and Combination Products. The syllabus also covers the change in Japan caused by the re-write of the Pharmaceutical Affairs Law [PAL] into the Pharmaceuticals & Medical Device Law [PMDL] and the country's latest update to GMP requirements.

Speaker: Robert J. Russell | View Anytime | Duration: 3 Hours | Price: $340.00 | View Details
Robert J. Russell

Drug Master Files: Understanding and Meeting your Regulatory and Processing Responsibilities

This combined Quality Agreement and DMF (Drug Master Files) training will discuss the advantages for suppliers and drug product manufacturers developing these arrangements together.

Speaker: Robert J. Russell | View Anytime | Price: $190.00 | View Details
Salma Michor

Combination Products Registration

During this introductory session, delegates will gain a complete guide to the status and impact of the latest guidelines for combination products. Examples (company specific) of combination products will also be discussed to gain insights into their variety and complexities.

Speaker: Salma Michor | View Anytime | Price: $190.00 | View Details
Salma Michor

The New EU Medical Device Regulation

Regulation proposals of the European Commission

Speaker: Salma Michor | View Anytime | Price: $190.00 | View Details
David R Dills

3-Hour Virtual Seminar on Complaint Handling and Management: From Receipt to Trending

An effective complaint handling system is an extremely important part of any quality system. Manufacturers should understand that any complaint received on a product shall be evaluated and, if necessary, thoroughly investigated and analyzed, and corrective action shall be taken.

Speaker: David R Dills | View Anytime | Duration: 3 Hours | Price: $340.00 | View Details
Ginette Collazo

Controlling Human Error in the Manufacturing Floor

Human error is known to be the major cause of quality and production losses in many industries. Although it is unlikely that human error will ever be totally eliminated, many human performance problems can be prevented. Human errors start at the design stage. From procedures, training, and workplace environment many variables that affect human behavior CAN be manipulated reducing the likelihood of these occurrences.

Speaker: Ginette Collazo | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Ginette Collazo

Training in Human Error: Reducing Training Related Errors

We will discuss elements of the training programs like curricula, training management systems, training effectiveness and other important elements of a compliant training program.

Speaker: Ginette Collazo | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Ginette Collazo

Controlling Human Error in the Manufacturing Floor

Human error is known to be the major cause of quality and production losses in many industries. Although it is unlikely that human error will ever be totally eliminated, many human performance problems can be prevented. Human errors start at the design stage. From procedures, training, and workplace environment many variables that affect human behavior CAN be manipulated reducing the likelihood of these occurrences.

Speaker: Ginette Collazo | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Ginette Collazo

Tools for Human Error Reduction

Human error is known to be the major cause of quality and production losses in many industries. Although it is unlikely that human error will ever be totally eliminated, many human performance problems can be prevented. Human errors start at the design stage. From procedures, training, and workplace environment many variables that affect human behavior CAN be manipulated reducing the likelihood of these occurrences.

Speaker: Ginette Collazo | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Ginette Collazo

Controlling Human Error in the Manufacturing Floor

Human error is known to be the major cause of quality and production losses in many industries. Although it is unlikely that human error will ever be totally eliminated, many human performance problems can be prevented. Human errors start at the design stage. From procedures, training, and workplace environment many variables that affect human behavior CAN be manipulated reducing the likelihood of these occurrences.

Speaker: Ginette Collazo | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Angela Bazigos

How to Implement Lean Documents and Lean Document Control to Cut Costs, while Maintaining Compliance with Regulatory Authority Requirements

This webinar will show you how to implement lean documents and lean document control to cut costs, while maintaining compliance with regulatory authority requirements.

Speaker: Angela Bazigos | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Dr. Ludwig Huber

Validation of Analytical Methods and Procedures

Analytical methods should be validated to ensure reliability, consistency and accuracy of analytical data. Method validation has been a requirement of FDA and international regulations and accreditation standards such as ISO 17025 since many years and new official guidelines have been published by FDA, EMA and USP in the last 4 years. Most often the theory is well understood but there are many questions when validation experiments are designed, conducted, and documented.

Speaker: Dr. Ludwig Huber | View Anytime | Duration: 75 Minutes | Price: $190.00 | View Details
Dr. Ludwig Huber

Understanding the USP Chapter 1224 for Transfer of Analytical Methods

When validated methods are transferred between laboratories and sites, their validated state should be maintained to ensure the same reliable results in the receiving laboratory.

Speaker: Dr. Ludwig Huber | View Anytime | Duration: 75 Minutes | Price: $190.00 | View Details
John N. Zorich

Better Alternatives to AQL Sampling Plans for Risk Management in Incoming QC

The pros and cons of the 2 most widely used sampling plans (ANSI Z1.4, and Squeglia's C=0) are examined in detail, focusing especially on the weaknesses of such plans in regards to meeting regulatory requirements. Real-world examples are provided for how using such sampling plans leads to production of non-conforming product.

Speaker: John N. Zorich | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
John N. Zorich

Valid Statistical Rationales for Sample Sizes

This webinar explains the logic behind sample-size choice for several statistical methods that are commonly used in verification or validation efforts, and how to express a valid statistical justification for a chosen sample size.

Speaker: John N. Zorich | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Eyal Lerner

The New ISO 13485: 2016 and Comparison with 21CFR820 - how to Comply with Both in the same Organization

Many medical devices are distributed in USA and in the European Union (EU). Each market has its own regulatory requirements which mainly focused on its quality management systems (QMS). The two QMS are described in two documents, one by the international ISO standard 13485 and the other by FDA Quality System Regulation (21CFR820).

Speaker: Eyal Lerner | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Danielle DeLucy

Batch Record Review and Product Release

Most Regulatory Agencies require firms to have written procedures in place to document production and process controls, better known as batch records. Additionally, there must be written procedures for a batch record review process that demonstrate compliance.

Speaker: Danielle DeLucy | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Derk Yntema

GDPR - European Privacy Regulation what and how

The GDPR (General Data Protection Regulation) compels companies that process Personally Identifiable Information (PII) of European citizens to demonstrate their insight in all PII processing going on in their business. After assessment by a Data Protection Officer (DPO), they should implement appropriate organizational and technical controls.

Speaker: Derk Yntema | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Angela Bazigos

Key Factors to Write an Effective Standard Operating Procedure (SOP) and Work Instructions (WIs)

This webinar will instruct the participant on how to write, organize, and maintain SOPs and train personnel in a way that will ensure compliance in a way that is concise, reproducible and easy to follow. It will begin with a strategic view of SOPs in a company and how SOPs can help streamline operations in addition to ensuring regulatory compliance. This will be followed by explanation on how to get from regulations to the SOP. Finally, Best Practices for creating, implementing and maintaining SOPs using a risk based approach and getting SOPs ready for inspection will be presented.

Speaker: Angela Bazigos | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Dennis Taylor

Mastering Excel Pivot Tables

PivotTable capabilities are enormous; among its many tools and features.

Speaker: Dennis Taylor | View Anytime | Price: $190.00 | View Details
Laura Brown

EU General Data Protection Regulation (GDPR): Compliance for Clinical Trials - are you Ready for Implementation for May 25th 2018?

Attain an understanding of the General Data Protection Regulation (GDPR).Be able to understand the key of the main tenets of GDPR which impact on clinical trials.

Speaker: Laura Brown | View Anytime | Price: $190.00 | View Details
Susanne Manz

Non-Conforming Material and Failure Investigation

Non-conforming material happens. And medical device companies must deal it. This 90-minute webinar will help you to make sense of confusing regulations and effectively deal with non-conforming material. You'll learn how to identify, segregate, control, and disposition non-conforming material. You'll learn about conducting failure investigations and requirements for correction and corrective action. Join industry expert, Susanne Manz from Manz Consulting Inc, to learn the essentials of dealing with non-conforming material.

Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Susanne Manz

Secrets to Writing Effective SOPs for Medical Device QMS

Standard Operating Procedures (SOPs) are a critical ingredient in an effective and efficient Quality Management System. SOPs are typically one of the first things an investigator asks for in an inspection. Well written SOPs send a message to the FDA and Notified Bodies that your QMS is complete, accurate, and followed. More importantly, well written SOPs ensure that your personnel can consistently and accurately follow your processes resulting in correct outcomes and quality work.

Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Susanne Manz

Death By CAPA - Does your CAPA Program Need a CAPA?

This webinar will help you establish an efficient and effective CAPA (Corrective and Preventive Action) process leading to improved quality and compliance for your company. You'll learn how to streamline and monitor your process to ensure compliance and improved performance. If your CAPA process needs a CAPA, this webinar is for you. We will discuss requirements, the myths, and the challenges of managing CAPAs so you can avoid common problems and pitfalls.

Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Jose Mora

Effective Design of Experiments (DOE) Strategies

This DOE (Design of experiments) training focuses on DOE strategies. It is not focused on statistical methods, analysis of variance, and other techniques, but rather the overall approach for successful DOEs.

Speaker: Jose Mora | View Anytime | Price: $190.00 | View Details
Edwin Waldbusser

21 CFR Part 11 - Compliance for Electronic Records and Signatures

This webinar details the regulation and how it applies to computerized systems.

Speaker: Edwin Waldbusser | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Jose Mora

Design History File (DHF), the Device Master Record (DMR) and the Device History Record (DHR) - Principles on Lean Documents and Lean Configuration

Design History Files (DHF), Device Master Records (DMR), and Device History Records (DHR) are key building blocks used in the design, development, manufacturing, and cGMP compliance for the Medical Device Industry. Too often, these are cluttered, confusing, and cause many errors due to the way they are created, organized, and managed.

Speaker: Jose Mora | View Anytime | Price: $190.00 | View Details
Dennis Taylor

Time-Saving Excel Tips, Tricks and 100 Shortcuts

Microsoft Excel has a tremendous amount of capability and features and is filled with shortcuts and methods not always visible to the casual user. Whether it's a keystroke shortcut or a hidden command sequence, such shortcuts can make you much more proficient and productive as you use this powerful and popular software.

Speaker: Dennis Taylor | View Anytime | Price: $190.00 | View Details
Robert J. Russell

Japan - Regulatory Filing Requirements and Compliance Processes for Life Sciences

This course specifically focuses on the overall regulatory compliance requirements and procedures for Pharmaceuticals, Medical Devices, Biologics and Combination Products in Japan. The course will cover topics relating to pre-clinical and clinical requirements, as well as, addressing the structure of the regulatory agencies in Japan. Content will also include descriptions of the methods by which regulators in the corresponding agencies process filings and registrations and what is expected in the authorization and dossier maintenance of licensed products.

Speaker: Robert J. Russell | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Robert J. Russell

Latin America Regulatory Compliance: Current Challenges in Argentina, Brazil and Mexico

The Latin America Regulatory compliance requirement training/webinar will cover topics across the full Life-Cycle of Company & Product licensing in the key markets of Latin America. Written Regulations vs. Skillful Negotiation will be explained across every critical topic. The importance of local resources, Agency meetings and knowing how to navigate the regulatory landscape will accelerate country establishment and successful product licensing.

Speaker: Robert J. Russell | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Dr. Ludwig Huber

Validation and Use of Excel® Spreadsheets in FDA Regulated Environments

Excel® Applications are widely used in laboratories, offices and manufacturing e.g., for data capture, data manipulation and report generation.

Speaker: Dr. Ludwig Huber | View Anytime | Duration: 75 Minutes | Price: $190.00 | View Details
Teri C. Soli

Water System Mythology: Common False Beliefs for Microbial Control and Monitoring

It is an unfortunate fact that most water systems today have been designed and are operated and controlled using at least some traditional concepts and methods that are downright wrong. So how could such traditions become so ingrained and be so wrong? How could well-intentioned benchmarking be so misguided?

Speaker: Teri C. Soli | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Casper Uldriks

FDA's Revolutionary Change in Software Regulation

Congress recognized that FDA struggles with software regulation. So, Congress removed some software out of FDA's jurisdiction. Now FDA must revise its premarket and postmarket software regulatory approach, including mobile apps. Using voluntary standards in premarket submissions can be used more effectively. Even more dramatic, FDA's new Digital Health initiative turns FDA's premarket clearance program on its head.

Speaker: Casper Uldriks | View Anytime | Price: $190.00 | View Details
Casper Uldriks

FDA's New Import Program for 2018

The FDA and U.S. Customs and Border Protection are using new import requirements. The FDA's import software screening program (PREDICT) and the U.S. Custom's ACE software program require more information from the foreign source(s). FDA's product codes and U.S. Harmonized Tariff Schedule (HTS) link the requirements. The software coding information must be correct. Otherwise, you face costly delays and possibly a refusal of the entry.

Speaker: Casper Uldriks | View Anytime | Price: $190.00 | View Details
Roger Cowan

HVAC and GMP Environmental Control for Pharmaceutical Clean Rooms

Environmental control of pharmaceutical clean rooms is essential to the manufacture of a quality product. The definition of Environmental Control vs. Environmental Monitoring is discussed. Control of such conditions as airborne particulate, microorganisms, temperature, humidity, differential pressure, airflow, air velocity and personnel is crucial to protect the product from contamination.

Speaker: Roger Cowan | View Anytime | Duration: 75 Minutes | Price: $190.00 | View Details
John N. Zorich

Better Alternatives to AQL Sampling Plans for Risk Management in Incoming QC

The pros and cons of the 2 most widely used sampling plans (ANSI Z1.4, and Squeglia's C=0) are examined in detail, focusing especially on the weaknesses of such plans in regards to meeting regulatory requirements. Real-world examples are provided for how using such sampling plans leads to production of non-conforming product.

Speaker: John N. Zorich | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Charles H. Paul

3-hour Virtual Seminar on Project Management for Non-Project Managers

This webinar will address those project management critical tasks within each project phase that must be performed flawlessly for effective project execution to occur and will provide the foundation and direction for future study of the subject.

Speaker: Charles H. Paul | View Anytime | Duration: 3 Hours | Price: $340.00 | View Details
Angela Bazigos

If it Isn't Written Down, then it Didn't Happen: Complying with FDA's Good Documentation Practices

Good documentation practice (commonly abbreviated GDP, recommended to abbreviate as GDocP to distinguish from "good distribution practice" also abbreviated GDP) is a term in the pharmaceutical and medical device industries to describe standards by which documents are created and maintained. In a pharmaceutical or medical device environment documentation needs to meet certain requirements to ensure product quality and product safety.

Speaker: Angela Bazigos | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Charles H. Paul

Project Management for Non-Project Managers

This webinar will address those project management critical tasks within each project phase that must be performed flawlessly for effective project execution to occur and will provide the foundation and direction for future study of the subject.

Speaker: Charles H. Paul | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Danielle DeLucy

Batch Record Review and Product Release

Most Regulatory Agencies require firms to have written procedures in place to document production and process controls, better known as batch records. Additionally, there must be written procedures for a batch record review process that demonstrate compliance.

Speaker: Danielle DeLucy | View Anytime | Price: $190.00 | View Details
Ginette Collazo

Supervising a Human Error Free Environment: You can do a Lot More than you Think

Human error is known to be the major cause of quality and production losses in many industries. Although it is unlikely that human error will ever be totally eliminated, many human performance problems can be prevented. Human errors start at the design stage. From procedures, training, supervision, and workplace environment many variables that affect human behavior CAN be manipulated reducing the likelihood of these occurrences.

Speaker: Ginette Collazo | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Dr. Ludwig Huber

FDA's New Enforcement of 21 CFR Part 11

FDA continues to enforce Part 11 through its new Part 11 inspection and enforcement program. Just in the last 3 years, FDA issued more than 30 warning letters with Part 11 violations. Citations are related to inadequate integrity, security and availability of electronic records but also related to validation of software and computer systems. There are many questions about the program, e.g., what inspectors are looking at what are major findings.

Speaker: Dr. Ludwig Huber | View Anytime | Duration: 75 Minutes | Price: $190.00 | View Details
Dr. Ludwig Huber

Understanding the USP Chapter 1224 for Transfer of Analytical Methods

When validated methods are transferred between laboratories and sites, their validated state should be maintained to ensure the same reliable results in the receiving laboratory.

Speaker: Dr. Ludwig Huber | View Anytime | Duration: 75 Minutes | Price: $190.00 | View Details
Susanne Manz

Quality is not an Organization

What does Quality mean to you? Is it a noun meaning an attribute or characteristic measured against a standard or customer requirement? Is it a state of product being free from defects? Is it an organization within your company that is responsible for creating inspection standards or a quality system? Or is it something more? It can be something more powerful for your company. It can be a culture of excellence and a management philosophy leading to improved customer satisfaction and business success.

Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Susanne Manz

Essentials of Validation - IQ, OQ, PQ

Validation is an important element of the Quality System Regulations and ISO13485. This course will cover the requirements the essentials of validation. You'll learn about what processes needed to be validated and what steps you need to take to validate processes. You'll learn the essentials of validation planning, protocol writing, and change management

Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Casper Uldriks

FDA's New Import Program for 2018

The FDA and U.S. Customs and Border Protection are using new import requirements. The FDA's import software screening program (PREDICT) and the U.S. Custom's ACE software program require more information from the foreign source(s). FDA's product codes and U.S. Harmonized Tariff Schedule (HTS) link the requirements. The software coding information must be correct. Otherwise, you face costly delays and possibly a refusal of the entry.

Speaker: Casper Uldriks | View Anytime | Price: $190.00 | View Details
David Ringstrom

Master Excel: Transcend the VLOOKUP Function

Excel expert David Ringstrom, CPA, introduces several lookup functions, including VLOOKUP, HLOOKUP, MATCH, and CHOOSE, in this valuable presentation. These powerful Excel functions allow you to rapidly develop accurate spreadsheets and look up information, such as pay rates, item prices, and accounting results, versus manually linking to specific cells. David explains the context of when to use lookup functions, demonstrates troubleshooting techniques, and prepares you to deal with subtle issues that can prevent them from working properly.

Speaker: David Ringstrom | View Anytime | Price: $190.00 | View Details
Derk Yntema

GDPR - European Privacy Regulation what and how

The GDPR (General Data Protection Regulation) compels companies that process Personally Identifiable Information (PII) of European citizens to demonstrate their insight in all PII processing going on in their business. After assessment by a Data Protection Officer (DPO), they should implement appropriate organizational and technical controls.

Speaker: Derk Yntema | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Steven S. Kuwahara

GMP Expectations for Products Used in Early Phase IND Studies

FDA issued a guidance document covering GMP requirements for Phase 1 products. These guidelines remove some of the problems that are encountered with early phase products and are in addition to those that cover the CMC sections for IND submissions at Phase 1.

Speaker: Steven S. Kuwahara | View Anytime | Duration: 75 Minutes | Price: $190.00 | View Details
Steven S. Kuwahara

Auditing Analytical Laboratories for FDA Compliance

Auditing analytical laboratories can be complex because of the preparation that is often required. All of the GMP rules do not apply to the laboratory; while there may be additional requirements depending upon the type of testing that is being conducted. In many cases, the laboratory itself may not understand what regulations apply to the work that is being conducted.

Speaker: Steven S. Kuwahara | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Angela Bazigos

How to Implement Lean Documents and Lean Document Control to Cut Costs, while Maintaining Compliance with Regulatory Authority Requirements

This webinar will show you how to implement lean documents and lean document control to cut costs, while maintaining compliance with regulatory authority requirements.

Speaker: Angela Bazigos | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Angela Bazigos

3 Hours Virtual Seminar on Boot Camp: Data Integrity - FDA's Latest Thinking

This webinar will give you the tools that you need to ensure that you understand data integrity issues and best practices for ensuring data integrity at your company.

Speaker: Angela Bazigos | View Anytime | Duration: 3 Hours | Price: $340.00 | View Details
Sheldon Primus

Laboratory Safety: Don't be Caught Unaware of Laboratory Hazards

In this webinar, we will explore the hazards related to the laboratory on many fronts. To understand the laboratory work environment as it relates to safety, the employer must consider what the materials the workers are exposed to on a daily basis.

Speaker: Sheldon Primus | View Anytime | Price: $190.00 | View Details
John E Lincoln

Design History Files (DHF), Device Master Records (DMR), Device History Records (DHR), Technical Files , Design Dossiers - The Requirements

It will also consider the European Union's MDD TF/DD requirements, and evaluate the documents' differing purposes / goals, as well as the two different device classification schemes. Required and desirable contents will be discussed.

Speaker: John E Lincoln | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Teri C. Soli

Water System Mythology: Common False Beliefs for Microbial Control and Monitoring

It is an unfortunate fact that most water systems today have been designed and are operated and controlled using at least some traditional concepts and methods that are downright wrong. So how could such traditions become so ingrained and be so wrong? How could well-intentioned benchmarking be so misguided?

Speaker: Teri C. Soli | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
David R Dills

FDA Issues Final Rule on Symbols in Labeling

The Food and Drug Administration (FDA or the Agency) issued this final rule revising its medical device and certain biological product labeling regulations to explicitly allow for the optional inclusion of graphical representations of information, or symbols, in labeling (including labels) without adjacent explanatory text (referred to in this document as "stand-alone symbols") if certain requirements are met.

Speaker: David R Dills | View Anytime | Price: $190.00 | View Details
Dr. Ludwig Huber

Validation and Use of Excel® Spreadsheets in FDA Regulated Environments

Excel® Applications are widely used in laboratories, offices and manufacturing e.g., for data capture, data manipulation and report generation.

Speaker: Dr. Ludwig Huber | View Anytime | Duration: 75 Minutes | Price: $190.00 | View Details
Dr. Ludwig Huber

Validation of Analytical Methods and Procedures

Analytical methods should be validated to ensure reliability, consistency and accuracy of analytical data. Method validation has been a requirement of FDA and international regulations and accreditation standards such as ISO 17025 since many years and new official guidelines have been published by FDA, EMA and USP in the last 4 years. Most often the theory is well understood but there are many questions when validation experiments are designed, conducted, and documented.

Speaker: Dr. Ludwig Huber | View Anytime | Duration: 75 Minutes | Price: $190.00 | View Details
Angela Bazigos

FDA's Enforcement of 21 CFR Part 11 Compliance

This presentation will cover the scope, status and results of the surveillance inspections and what they may mean for the future of 21 CFR Part 11. This will enable you to determine whether your company is subject to the most common violations so you can take action to have a better inspection outcome.

Speaker: Angela Bazigos | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Ginette Collazo

Controlling Human Error in the Manufacturing Floor

Human error is known to be the major cause of quality and production losses in many industries. Although it is unlikely that human error will ever be totally eliminated, many human performance problems can be prevented. Human errors start at the design stage. From procedures, training, and workplace environment many variables that affect human behavior CAN be manipulated reducing the likelihood of these occurrences.

Speaker: Ginette Collazo | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
John N. Zorich

Valid Statistical Rationales for Sample Sizes

This webinar explains the logic behind sample-size choice for several statistical methods that are commonly used in verification or validation efforts, and how to express a valid statistical justification for a chosen sample size.

Speaker: John N. Zorich | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
David R Dills

Complaint Handling and Management: From Receipt to Trending

An effective complaint handling system is an extremely important part of any quality system. Manufacturers should understand that any complaint received on a product shall be evaluated and, if necessary, thoroughly investigated and analyzed, and corrective action shall be taken.

Speaker: David R Dills | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Dennis Taylor

Mastering Excel Pivot Tables

PivotTable capabilities are enormous; among its many tools and features.

Speaker: Dennis Taylor | View Anytime | Price: $190.00 | View Details
Dennis Taylor

Time-Saving Excel Tips, Tricks and 100 Shortcuts

Microsoft Excel has a tremendous amount of capability and features and is filled with shortcuts and methods not always visible to the casual user. Whether it's a keystroke shortcut or a hidden command sequence, such shortcuts can make you much more proficient and productive as you use this powerful and popular software.

Speaker: Dennis Taylor | View Anytime | Price: $190.00 | View Details
Dennis Taylor

Mastering Excel 2013 Pivot Tables

PivotTable capabilities are enormous; among its many tools and features.

Speaker: Dennis Taylor | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Peggy Berry

Complaint Handling

The information obtained will enable preparation of effective internal systems for receiving, investigating and responding to product complaints during both the investigational and commercial stages. The webinar will address aspects of the review process, SOP preparation, investigation documentation, and response to complainants.

Speaker: Peggy Berry | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Carolyn Troiano

21 CFR Part 11 Guidance for Electronic Records and Electronic Signatures in FDA-Regulated Industries

The Webinar will focus on the importance of ensuring that electronic record/electronic signature (ER/ES) capability built into FDA-regulated computer systems meets compliance with 21 CFR Part 11. This includes development of a company philosophy and approach, and incorporating it into the overall computer system validation program and plans for individual systems that have this capability.

Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Carolyn Troiano

Computer System Validation (CSV) for FDA-Regulated Computers

FDA requires that all computer systems used to produce, manage and report on GxP (GMP, GLC, GCP) related products be validated and maintained in accordance with specific rules. This webinar will leave you with the information needed to plan, execute and document a computer system validation effort that meets FDA compliance standards.

Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Casper Uldriks

FDA's New Import Program for 2018

The FDA and U.S. Customs and Border Protection are using new import requirements. The FDA's import software screening program (PREDICT) and the U.S. Custom's ACE software program require more information from the foreign source(s). FDA's product codes and U.S. Harmonized Tariff Schedule (HTS) link the requirements. The software coding information must be correct. Otherwise, you face costly delays and possibly a refusal of the entry. In addition, information on the entry's commercial or pro forma invoice must be consistent with the information entered into PREDICT and ACE software. FDA offers some relief from the strict requirements if you participate in a voluntary Affirmation of Compliance (AOC). Providing accurate information is necessary in order to reconcile the PREDICD, ACE, Invoice and AOC information. Your failure to accomplish these tasks can lead to smooth sailing or to a whirlpool of costly delays and fines. Time is not on your side during the import process. Time is money; the more you use, the more you lose.

Speaker: Casper Uldriks | View Anytime | Price: $190.00 | View Details
Michael Abitz

Fishbone Diagramming

Fishbone Diagramming is an analytical approach used to identify and solve problems. Analysis is presented in the Seven Basic Tools of Quality in addition to advanced methods used to increase organizations effectiveness, efficiency and reliability.

Speaker: Michael Abitz | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Michael Abitz

Root Cause Failure Analysis Closed Loop Corrective Action

Root Cause Failure Analysis is an analytical approach used to identify and solve problems. Analysis is presented in the Seven Basic Tools of Quality in addition to advanced methods used to increase organizations effectiveness, efficiency and reliability.

Speaker: Michael Abitz | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
John N. Zorich

Understanding, Calculating, and Using Statistical Power

Statistical power is an indicator of the ability of a test of significance to "detect" a practical difference (e.g., between the averages of two products that are being compared). A low power typically means that the sample sizes in the study are too small. Without an analysis of statistical power, a conclusion of "non-significant" is rightfully questionable. Unless power is high, a study may be doomed to failure even before it is begun.

Speaker: John N. Zorich | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
John C. Fetzer

HPLC Analytical Method Development and Validation

Instrumental liquid chromatography is an analysis are widely used to determine purity, the impurities, and the degradation products of pharmaceuticals. The focus of most validation work is on the methodology, the standard operating procedure (SOP). But validation of the instrumentation and other associated items of column, solvents, and other reagents and chemicals is also an area of focus in an audit.

Speaker: John C. Fetzer | View Anytime | Price: $190.00 | View Details
John C. Fetzer

Analytical Method Validation Under Good Laboratory Practices - GLPs

If you do any work that will be reported to the US Food and Drug Administration (FDA), Environmental Protection Agency (EPA), or Occupational Safety and Health Administration (OSHA), your work must be done under GLP. All methods must be validated, the proof that they do what is claimed. Common criteria are accuracy, precision, linearity, range, and several more.

Speaker: John C. Fetzer | View Anytime | Price: $190.00 | View Details
Joy McElroy

GLPs: How are they Associated with GMPs and SOPs

In this webinar you will learn what GLPs are, why they were created, what is the objective of GLPs, and how they relate and are associated with GMPs.

Speaker: Joy McElroy | View Anytime | Price: $190.00 | View Details
John E Lincoln

Verification vs Validation-Product, Process or Equipment and QMS Software

The verification and validation of regulated software is coming under increased scruinty by the U.S. FDA.This webinar will address the use of the FDA, GAMP, 21 CFR Part 11,"Electronic Records"/"Electronic Signatures", IEC 62304, and other applicable industry software validation models, coupled with the ISO 14971/ICH Q9 Product Risk Management models, to plan, structure, run, and document acceptable software validations.

Speaker: John E Lincoln | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Vanessa Lopez

Best Practices to Prepare for and Manage FDA Inspections

Preparing for and managing an FDA Inspection; the actual flow of company activities and roles; the inspection process, and the impact of non-compliance to FDA requirements on the medical devices/pharmaceutical firms, competiveness in the market, revenue, distribution, reliability status, and partnerships with suppliers, among others. It will also provides the challenges from the results of an inspection, in preparing and managing an inspection, and the benefits of successful results from an FDA inspection.

Speaker: Vanessa Lopez | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Shep Bentley

Medical Device Single Audit Program (MDSAP) Preparation

The International Medical Device Regulators Forum (IMDRF) recognizes that a global approach to auditing and monitoring the manufacturing of medical devices could improve their safety and oversight on an international scale. At its inaugural meeting in Singapore in 2012, the IMDRF identified a work group to develop specific documents for advancing a Medical Device Single Audit Program (MDSAP).

Speaker: Shep Bentley | View Anytime | Price: $190.00 | View Details
Edwin Waldbusser

How to Conduct a Human Factors - Usability Validation Test following ISO 62366 and the 2016 FDA Guidance

This webinar will explain the procedure described in ISO62366 and the 2016 FDA Guidance for a compliant human factors/usability validation. HF/U validation is very different from device validation. For example, success criteria is qualitative rather than quantitative as is in device validation. Claiming success because eg. 95% of test participants did not commit a user error is not valid. Nor is 100% positive test results sufficient.

Speaker: Edwin Waldbusser | View Anytime | Price: $190.00 | View Details
Edwin Waldbusser

Medical Device Software Validation Meeting FDA Regulations

This course will teach how to conduct a software validation program for medical devices containing software that will satisfy FDA requirements and produce a safe product. We will explain the role of risk analysis in validation. How software requirements are used in validation will be described.

Speaker: Edwin Waldbusser | View Anytime | Price: $190.00 | View Details
Robert J. Russell

Latin America Regulatory Compliance: Current Challenges in Argentina, Brazil and Mexico

The Latin America Regulatory compliance requirement training/webinar will cover topics across the full Life-Cycle of Company & Product licensing in the key markets of Latin America. Written Regulations vs. Skillful Negotiation will be explained across every critical topic. The importance of local resources, Agency meetings and knowing how to navigate the regulatory landscape will accelerate country establishment and successful product licensing.

Speaker: Robert J. Russell | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Karl J Hemmerich

Accelerated Aging Techniques for Medical Device Products

Accelerated aging (AA) is testing that uses aggravated conditions of heat, oxygen, sunlight, vibration, chemicals, etc. to speed up the normal aging processes of items. It is used to help determine the long-term effects of expected levels of stress within a shorter time, usually in a laboratory by controlled standard test methods.

Speaker: Karl J Hemmerich | View Anytime | Price: $190.00 | View Details
John N. Zorich

Better Alternatives to AQL Sampling Plans for Risk Management in Incoming QC

The pros and cons of the 2 most widely used sampling plans (ANSI Z1.4, and Squeglia's C=0) are examined in detail, focusing especially on the weaknesses of such plans in regards to meeting regulatory requirements. Real-world examples are provided for how using such sampling plans leads to production of non-conforming product.

Speaker: John N. Zorich | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Steven S. Kuwahara

Auditing Analytical Laboratories for FDA Compliance

Auditing analytical laboratories can be complex because of the preparation that is often required. All of the GMP rules do not apply to the laboratory; while there may be additional requirements depending upon the type of testing that is being conducted. In many cases, the laboratory itself may not understand what regulations apply to the work that is being conducted.

Speaker: Steven S. Kuwahara | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Robert J. Russell

Japan - Regulatory Filing Requirements and Compliance Processes for Life Sciences

This course specifically focuses on the overall regulatory compliance requirements and procedures for Pharmaceuticals, Medical Devices, Biologics and Combination Products in Japan. The course will cover topics relating to pre-clinical and clinical requirements, as well as, addressing the structure of the regulatory agencies in Japan. Content will also include descriptions of the methods by which regulators in the corresponding agencies process filings and registrations and what is expected in the authorization and dossier maintenance of licensed products.

Speaker: Robert J. Russell | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Susanne Manz

Death By CAPA - Does your CAPA Program Need a CAPA?

This webinar will help you establish an efficient and effective CAPA (Corrective and Preventive Action) process leading to improved quality and compliance for your company. You'll learn how to streamline and monitor your process to ensure compliance and improved performance. If your CAPA process needs a CAPA, this webinar is for you. We will discuss requirements, the myths, and the challenges of managing CAPAs so you can avoid common problems and pitfalls.

Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Thomas E. Colonna

FDA Regulation of Dietary Supplements

FDA regulates both finished dietary supplement products and dietary ingredients. FDA regulates dietary supplements under a different set of regulations than those covering "conventional" foods and drug products. Under the Dietary Supplement Health and Education Act of 1994 (DSHEA).

Speaker: Thomas E. Colonna | View Anytime | Price: $190.00 | View Details
Derk Yntema

GDPR - European Privacy Regulation what and how

The GDPR (General Data Protection Regulation) compels companies that process Personally Identifiable Information (PII) of European citizens to demonstrate their insight in all PII processing going on in their business. After assessment by a Data Protection Officer (DPO), they should implement appropriate organizational and technical controls.

Speaker: Derk Yntema | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Teri C. Soli

Water System Mythology: Common False Beliefs for Microbial Control and Monitoring

It is an unfortunate fact that most water systems today have been designed and are operated and controlled using at least some traditional concepts and methods that are downright wrong. So how could such traditions become so ingrained and be so wrong? How could well-intentioned benchmarking be so misguided?

Speaker: Teri C. Soli | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Mike Thomas

Mastering Excel Formulas and Functions

Using formulas turns Excel into the world's most powerful calculator. Whether you need to calculate loan repayments, generate a profit and loss account, solve maths or engineering problems, in fact, think of any scenario that involves addition, subtraction, division or multiplication of numbers and you'll find that Excel is the best tool for the job.

Speaker: Mike Thomas | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Dr. Ludwig Huber

Validation of Analytical Methods and Procedures

Analytical methods should be validated to ensure reliability, consistency and accuracy of analytical data. Method validation has been a requirement of FDA and international regulations and accreditation standards such as ISO 17025 since many years and new official guidelines have been published by FDA, EMA and USP in the last 4 years. Most often the theory is well understood but there are many questions when validation experiments are designed, conducted, and documented. This webinar will provide a good understanding on how to effectively conduct and document method validation, method re-validation and periodic review.

Speaker: Dr. Ludwig Huber | View Anytime | Duration: 75 Minutes | Price: $190.00 | View Details
Dennis Taylor

Mastering Excel 2013 Pivot Tables

PivotTable capabilities are enormous; among its many tools and features.

Speaker: Dennis Taylor | View Anytime | Price: $190.00 | View Details
John N. Zorich

Valid Statistical Rationales for Sample Sizes

This webinar explains the logic behind sample-size choice for several statistical methods that are commonly used in verification or validation efforts, and how to express a valid statistical justification for a chosen sample size.

Speaker: John N. Zorich | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Michael Esposito

Onboarding Employees in a GMP Environment: Best Practices for Foundational Employee Success

The FDA's expectations for training new employees are summed up in 21 CFR 211.25(a), i.e., pharmaceutical professionals require the education, training and experience to complete their job functions. Onboarding new or transferred employees in a Pharmaceutical Good Manufacturing Practices (GMP) environment and ensuring compliance with these requirements create some unique challenges.

Speaker: Michael Esposito | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Michael Esposito

Packaging and Labeling in the Pharmaceutical Supply Chain

Packaging and Labeling form a bridge between the conception of a product and its realization and distribution, and consequently occupy a critical position in the success or failure of any pharmaceutical product launch or revision. Decision-makers need at least a cursory knowledge of potential pitfalls to create contingencies, as it is easier and more cost-effective to change things earlier in process than later.

Speaker: Michael Esposito | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Angela Bazigos

European Data Protection Regulation - 2018 Implementation

On 4 May 2016, the official texts of the Regulation and the Directive have been published in the EU Official Journal in all the official languages. While the Regulation will enter into force on 24 May 2016, it shall apply from 25 May 2018. The Directive enters into force on 5 May 2016 and EU Member States have to transpose it into their national law by 6 May 2018.

Speaker: Angela Bazigos | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Dr. Ludwig Huber

FDA's New Enforcement of 21 CFR Part 11

FDA continues to enforce Part 11 through its new Part 11 inspection and enforcement program. Just in the last 3 years, FDA issued more than 30 warning letters with Part 11 violations. Citations are related to inadequate integrity, security and availability of electronic records but also related to validation of software and computer systems. There are many questions about the program, e.g., what inspectors are looking at what are major findings.

Speaker: Dr. Ludwig Huber | View Anytime | Duration: 75 Minutes | Price: $190.00 | View Details
Dr. Ludwig Huber

Understanding the USP Chapter 1224 for Transfer of Analytical Methods

When validated methods are transferred between laboratories and sites, their validated state should be maintained to ensure the same reliable results in the receiving laboratory.

Speaker: Dr. Ludwig Huber | View Anytime | Duration: 75 Minutes | Price: $190.00 | View Details
Dr. David Lim

GCP-GLP-GMP : Comparison and Understanding of FDA's 3 Major Regulations

For manufacturers for drugs, biologics, biosimilars, generics, and medical devices, firms are subject to various statutory and regulatory requirements under FDA regulations governing Good Laboratory Practice (GLP), Good Clinical Practice (GCP) and current Good Manufacturing Practice (cGMP). To provide safe and effective medical products, it is important for the FDA-regulated industry to accurately understand and apply the applicable regulations and requirements under GLP, GCP and GMP.

Speaker: Dr. David Lim | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Carolyn Troiano

Good Documentation Practices to Support FDA Computer System Validation

As a "GxP" system, following Good Manufacturing, Laboratory and Clinical Practices, the computer system must be validated in accordance with FDA requirements. If electronic records and/or electronic signatures (ER/ES) are incorporated into the system, FDA's CFR Part 11 guidance on ER/ES must be followed. This webinar will help you understand the FDA's requirements for good documentation, including how to handle change control and the importance of audit trails.

Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Louis Angelucci

Understanding Proper Application of Risk Assessment

Risk Assessment is a fundamental expectation in the regulated industries of pharmaceutical and medical devices. Performing risk assessments can be interpretive and needs to be well thought out in order to rationalize and substantiate conclusions drawn. With proper use it is a good model and will save in terms of dollars and schedule when properly applied. Risk Assessment is a regulatory expectation that should be taught and emphasized at all levels of a going concern.

Speaker: Louis Angelucci | View Anytime | Price: $190.00 | View Details
Louis Angelucci

2011 FDA Guideline on Process Validation

The FDA in 2011 instituted its latest interpretation. Many have not chosen to take it seriously or change their business model. The paradigm has shifted and this presentation will articulate what has changed and how we need to react. Validation as derived from industry practice has a new spin. This presentation will take you through that development and demonstrate how some in the industry have reacted to the new expectations.

Speaker: Louis Angelucci | View Anytime | Price: $190.00 | View Details
Salma Michor

The New EU Medical Device Regulation

Regulation proposals of the European Commission

Speaker: Salma Michor | View Anytime | Price: $190.00 | View Details
Salma Michor

Combination Products Registration

During this introductory session, delegates will gain a complete guide to the status and impact of the latest guidelines for combination products. Examples (company specific) of combination products will also be discussed to gain insights into their variety and complexities.

Speaker: Salma Michor | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Mike Thomas

Get Organised with Microsoft Outlook

If you're like millions of other business professionals, you probably use Microsoft Outlook every day to manage your email, calendar and to do's. It's available for Windows, Mac, mobile and there's even a web version. So there's no excuse not to be organised. Or so the theory goes. The reality is email overload, missed deadlines and calendars so full you have no room to breathe.

Speaker: Mike Thomas | View Anytime | Price: $190.00 | View Details
Mike Thomas

OneNote - Bringing Order to your Digital Chaos

OneNote is a digital notebook. It is available for Windows, Mac and mobile. Use it to capture, store and organise your ideas and information. OneNote notes can store text, images, videos, embedded files and even drawings and sketches. OneNote notebooks can be shared with colleagues and customers, in fact anyone, making it the perfect platform for collaborative work. Use OneNote to manage your projects. Use OneNote to manage your meetings. Use OneNote to manage your life.

Speaker: Mike Thomas | View Anytime | Price: $190.00 | View Details
Jonathan M. Lewis

FDA Inspections - Do's and Don'ts

Most federal laws concerning the FDA are part of the Food, Drug and Cosmetic Act which are codified in Title 21 of the United States Code. However, the language in the law and regulations is often very vague and difficult to interpret. Hence, FDA inspections often result in observations and compliance actions that cost manufacturers and marketers of FDA regulated products hundreds of hours and sometimes millions of dollars to address to the satisfaction of the agency.

Speaker: Jonathan M. Lewis | View Anytime | Price: $190.00 | View Details
Lena Cordie

Software Verification & Validation

Software problems are now the third-leading cause for recalls of medical devices. Most recalls are because of incorrect verification and validation for safety. Most of the knowledge on how to do a comprehensive V&V is not widely understood.

Speaker: Lena Cordie | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
John N. Zorich

Better Alternatives to AQL Sampling Plans for Risk Management in Incoming QC

The pros and cons of the 2 most widely used sampling plans (ANSI Z1.4, and Squeglia's C=0) are examined in detail, focusing especially on the weaknesses of such plans in regards to meeting regulatory requirements. Real-world examples are provided for how using such sampling plans leads to production of non-conforming product.

Speaker: John N. Zorich | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Jane Hennessy

Managing Higher-Risk Business Customers

Financial institutions and others in the payments ecosystem must comply with regulations related to due diligence of business customers, as well as ongoing monitoring of their portfolios. A strong KYC program also includes an assessment of business customer risk. How can financial institutions and processors effectively determine what the risks are and how to manage them? This session will provide guidance on assessing business customer risk both at onboarding and ongoing, as well as best practices for taking a risk-based approach to Know Your Customer (KYC) and Know Your Customers' Customers (KYCC).

Speaker: Jane Hennessy | View Anytime | Price: $190.00 | View Details
Michael Abitz

Root Cause Failure Analysis Closed Loop Corrective Action

This course covers Root Cause Failure Analysis,Closed Loop Corrective Action, which is used to identity multiple roots to organizational problems and eliminate causes affecting, internal, external customer satisfaction, cost of doing business, quality, schedule, safety and security issues. Emphasis is on evidence gathering for each suspected cause before attempting solutions with The Model for Improvement. Also presented are suggestions for keeping processes safe from competitors and cyber-attacks from insurgents.

Speaker: Michael Abitz | View Anytime | Price: $190.00 | View Details
Dennis Taylor

Time-Saving Excel Tips, Tricks and 100 Shortcuts

Microsoft Excel has a tremendous amount of capability and features and is filled with shortcuts and methods not always visible to the casual user. Whether it's a keystroke shortcut or a hidden command sequence, such shortcuts can make you much more proficient and productive as you use this powerful and popular software.

Speaker: Dennis Taylor | View Anytime | Price: $190.00 | View Details
Joy McElroy

GLPs: How are they Associated with GMPs and SOPs

In this webinar you will learn what GLPs are, why they were created, what is the objective of GLPs, and how they relate and are associated with GMPs.

Speaker: Joy McElroy | View Anytime | Price: $190.00 | View Details
Jerry Lanese

Analytical Method Validation

An analytical method is a process. The FDA process validation guidance applies to test methods, like all other processes in the pharmaceutical industry. Therefore, the laboratory or laboratories must demonstrate that a test method performs as intended through the method lifecycle.

Speaker: Jerry Lanese | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Jerry Lanese

Laboratory Investigation of Out-of-Specification Results

The objective of this webinar is to develop an understanding of how a compliant laboratory handles the investigation of out-of-specification (OOS) test results and how the laboratory interfaces with other units through the laboratory investigation process. The discussion will be based on the FDA guidance on handling OOS laboratory results.

Speaker: Jerry Lanese | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Karl J Hemmerich

Accelerated Aging Techniques for Medical Device Products

Accelerated aging (AA) is testing that uses aggravated conditions of heat, oxygen, sunlight, vibration, chemicals, etc. to speed up the normal aging processes of items. It is used to help determine the long-term effects of expected levels of stress within a shorter time, usually in a laboratory by controlled standard test methods.

Speaker: Karl J Hemmerich | View Anytime | Price: $190.00 | View Details
Dan OLeary

Excel Workbooks and FDA Device Regulations

This presentation helps participants understand the FDA's device regulations for Excel workbooks. These workbooks could automate process, influence product decisions, support regulatory submissions, or create electronic records. FDA regulations cover both the use of workbooks and the creation of electronic records; device manufacturers must understand these regulations and their application.

Speaker: Dan OLeary | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Dan OLeary

Understanding Attribute Acceptance Sampling Plans Including the Z1.4 and c=0 Plans

Attribute acceptance sampling is a common tool for medical device manufacturers. Unfortunately, many people don't understand the underlying concepts or the basis for decision making. This presentation explains the underlying ideas of attribute sampling plans and how to use the two most common published plans, Z1.4 and c=0. In addition, the presentation describes the major differences between the approaches. Attribute sampling plans are characterized by the operating characteristic curve (OC curve) which provides the basis for sampling risk. The presentation explains how to read the OC and use it to help select sampling plans.

Speaker: Dan OLeary | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
John C. Fetzer

Analytical Method Validation Under Good Laboratory Practices - GLPs

If you do any work that will be reported to the US Food and Drug Administration (FDA), Environmental Protection Agency (EPA), or Occupational Safety and Health Administration (OSHA), your work must be done under GLP. All methods must be validated, the proof that they do what is claimed. Common criteria are accuracy, precision, linearity, range, and several more.

Speaker: John C. Fetzer | View Anytime | Price: $190.00 | View Details
Derk Yntema

GDPR - European Privacy Regulation what and how

The GDPR (General Data Protection Regulation) compels companies that process Personally Identifiable Information (PII) of European citizens to demonstrate their insight in all PII processing going on in their business. After assessment by a Data Protection Officer (DPO), they should implement appropriate organizational and technical controls.

Speaker: Derk Yntema | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Laura Brown

How to Audit Against ICH GCP 2 Addendum to Ensure Compliance

It is important GCP Auditors to understand how to audit the changes required by the new ICH GCP R2 Addendum. To consider how audit checklists and procedures should have been updated to ensure the new requirements are met and their organisations are ready for regulatory inspection. The session will also include an update on the proposed further major revision of ICH GCP R2 planned by ICH to start later next year. The new guideline includes a number of "hot" GCP inspection topics which are also covered in a number of other EU and FDA guidelines and documents, such as risk-based approaches for running clinical trials. These new approaches are going to be areas inspectors will be focussing on.

Speaker: Laura Brown | View Anytime | Price: $190.00 | View Details
Angela Bazigos

Key Factors to Write an Effective Standard Operating Procedure (SOP) and Work Instructions (WIs)

This webinar will instruct the participant on how to write, organize, and maintain SOPs and train personnel in a way that will ensure compliance in a way that is concise, reproducible and easy to follow. It will begin with a strategic view of SOPs in a company and how SOPs can help streamline operations in addition to ensuring regulatory compliance. This will be followed by explanation on how to get from regulations to the SOP. Finally, Best Practices for creating, implementing and maintaining SOPs using a risk based approach and getting SOPs ready for inspection will be presented.

Speaker: Angela Bazigos | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Dr. Ludwig Huber

Validation and Use of Excel® Spreadsheets in FDA Regulated Environments

Excel® Applications are widely used in laboratories, offices and manufacturing e.g., for data capture, data manipulation and report generation.

Speaker: Dr. Ludwig Huber | View Anytime | Duration: 75 Minutes | Price: $190.00 | View Details
Casper Uldriks

FDA's New Import Program for 2018

The FDA and U.S. Customs and Border Protection are using new import requirements. The FDA's import software screening program (PREDICT) and the U.S. Custom's ACE software program require more information from the foreign source(s). FDA's product codes and U.S. Harmonized Tariff Schedule (HTS) link the requirements. The software coding information must be correct. Otherwise, you face costly delays and possibly a refusal of the entry. In addition, information on the entry's commercial or pro forma invoice must be consistent with the information entered into PREDICT and ACE software. FDA offers some relief from the strict requirements if you participate in a voluntary Affirmation of Compliance (AOC). Providing accurate information is necessary in order to reconcile the PREDICD, ACE, Invoice and AOC information. Your failure to accomplish these tasks can lead to smooth sailing or to a whirlpool of costly delays and fines. Time is not on your side during the import process. Time is money; the more you use, the more you lose.

Speaker: Casper Uldriks | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Teri C. Soli

Water System Mythology: Common False Beliefs for Microbial Control and Monitoring

It is an unfortunate fact that most water systems today have been designed and are operated and controlled using at least some traditional concepts and methods that are downright wrong. So how could such traditions become so ingrained and be so wrong? How could well-intentioned benchmarking be so misguided?

Speaker: Teri C. Soli | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Angela Bazigos

FDA's 21 CFR 11 Add-On Inspections - Recent Updates

In December 2010 FDA started the Part 11 inspection initiative. While originally the initiative was supposed to last 3-6 months, it has now turned into an ongoing program with Part 11 related issues being part of most future inspections. At the beginning of the initiative FDA made it very clear that Part 11 is in effect and is enforced according to the original Part 11 and the Guidance from 2003. In the meantime FDA officials reported about key findings. For example, George Smith who heads up FDA's Part 11 working group gave an update with examples of violations.

Speaker: Angela Bazigos | View Anytime | Duration: 2 Hours | Price: $190.00 | View Details
Mike Thomas

Mastering Excel Formulas and Functions

Using formulas turns Excel into the world's most powerful calculator. Whether you need to calculate loan repayments, generate a profit and loss account, solve maths or engineering problems, in fact, think of any scenario that involves addition, subtraction, division or multiplication of numbers and you'll find that Excel is the best tool for the job.

Speaker: Mike Thomas | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Susanne Manz

Secrets to Writing Effective SOPs for Medical Device QMS

Standard Operating Procedures (SOPs) are a critical ingredient in an effective and efficient Quality Management System. SOPs are typically one of the first things an investigator asks for in an inspection. Well written SOPs send a message to the FDA and Notified Bodies that your QMS is complete, accurate, and followed. More importantly, well written SOPs ensure that your personnel can consistently and accurately follow your processes resulting in correct outcomes and quality work.

Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Dr. Ludwig Huber

Validation of Analytical Methods and Procedures

Analytical methods should be validated to ensure reliability, consistency and accuracy of analytical data. Method validation has been a requirement of FDA and international regulations and accreditation standards such as ISO 17025 since many years and new official guidelines have been published by FDA, EMA and USP in the last 4 years. Most often the theory is well understood but there are many questions when validation experiments are designed, conducted, and documented. This webinar will provide a good understanding on how to effectively conduct and document method validation, method re-validation and periodic review.

Speaker: Dr. Ludwig Huber | View Anytime | Duration: 75 Minutes | Price: $190.00 | View Details
Angela Bazigos

FDA's Enforcement of 21 CFR Part 11 Compliance

This presentation will cover the scope, status and results of the surveillance inspections and what they may mean for the future of 21 CFR Part 11. This will enable you to determine whether your company is subject to the most common violations so you can take action to have a better inspection outcome.

Speaker: Angela Bazigos | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Ginette Collazo

Tools for Human Error Reduction

Human error is known to be the major cause of quality and production losses in many industries. Although it is unlikely that human error will ever be totally eliminated, many human performance problems can be prevented. Human errors start at the design stage. From procedures, training, and workplace environment many variables that affect human behavior CAN be manipulated reducing the likelihood of these occurrences.

Speaker: Ginette Collazo | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Ginette Collazo

Controlling Human Error in the Manufacturing Floor

Human error is known to be the major cause of quality and production losses in many industries. Although it is unlikely that human error will ever be totally eliminated, many human performance problems can be prevented. Human errors start at the design stage. From procedures, training, and workplace environment many variables that affect human behavior CAN be manipulated reducing the likelihood of these occurrences.

Speaker: Ginette Collazo | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Dennis Taylor

Mastering Excel 2013 Pivot Tables

PivotTable capabilities are enormous; among its many tools and features.

Speaker: Dennis Taylor | View Anytime | Price: $190.00 | View Details
Jeff Kasoff

How FDA Trains its Investigators to Review CAPA and What you Should do to Prepare

Year after year, CAPA is the subsystem cited most frequently during FDA inspections. During an inspection, FDA personnel will take a great deal of time reviewing your company's CAPA system. What will they look for? This session will discuss techniques used by the FDA to review your CAPA system. The documents used by FDA to train their inspectors to review your CAPA system will be explained, some of which you may not be familiar with.

Speaker: Jeff Kasoff | View Anytime | Price: $190.00 | View Details
Angela Bazigos

3-hour Virtual Seminar on Analytical Method Validation Process

Use of analytical methods is widespread. However, there are no formally accepted guideline or formats for the overall process of design, development, optimization & validation of analytical methods.Many analytical methods, lacking full and adequate validation have been introduced into the open literature and allowed to assume aura of authenticity but, they may never work or be useful with samples that are typically encountered.

Speaker: Angela Bazigos | View Anytime | Duration: 3 Hours | Price: $340.00 | View Details
Dr. Ludwig Huber

FDA's New Enforcement of 21 CFR Part 11

FDA continues to enforce Part 11 through its new Part 11 inspection and enforcement program. Just in the last 3 years, FDA issued more than 30 warning letters with Part 11 violations. Citations are related to inadequate integrity, security and availability of electronic records but also related to validation of software and computer systems. There are many questions about the program, e.g., what inspectors are looking at what are major findings.

Speaker: Dr. Ludwig Huber | View Anytime | Duration: 75 Minutes | Price: $190.00 | View Details
John N. Zorich

Valid Statistical Rationales for Sample Sizes

This webinar explains the logic behind sample-size choice for several statistical methods that are commonly used in verification or validation efforts, and how to express a valid statistical justification for a chosen sample size.

Speaker: John N. Zorich | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Angela Bazigos

Excel Spreadsheet Validation for FDA 21 CFR Part 11

This webinar will describe the regulatory and business requirements for Excel spreadsheets, using examples from FDA recommendations. It will then cover the design and installation of those Excel Spreadsheets, to ensure the integrity of the data, and will discuss how to ensure 21 CFR 11 compliance during the development, installation and maintenance of a spreadsheet application.

Speaker: Angela Bazigos | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
David R Dills

Complaint Handling and Management: From Receipt to Trending

An effective complaint handling system is an extremely important part of any quality system. Manufacturers should understand that any complaint received on a product shall be evaluated and, if necessary, thoroughly investigated and analyzed, and corrective action shall be taken.

Speaker: David R Dills | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Eyal Lerner

The New ISO 13485:2016 and Comparison with 21CFR820 - How to Comply with both in the Same Organization

Many medical devices are distributed in USA and in the European Union (EU). Each market has its own regulatory requirements which mainly focused on its quality management systems (QMS). The two QMS are described in two documents, one by the international ISO standard 13485 and the other by FDA Quality System Regulation (21CFR820).

Speaker: Eyal Lerner | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Angela Bazigos

3-Hour Virtual Seminar on Off label Promotion of Drugs and Medical Devices - FDA's Latest

Off Label Promotion for Drugs and Medical Devices is a controversial topic which often puts FDA and industry at loggerheads. FDA continues to need to ensure public health by protect public health by ensuring that medical products distributed in the United States are safe and effective for their intended use while industry believes that safe and effective off label use is warranted. It is further complicated by today's patient who is much more savvy with regards to treatment and sometimes demands off-label use of products.

Speaker: Angela Bazigos | View Anytime | Duration: 3 Hours | Price: $340.00 | View Details
Thomas E. Colonna

The Dietary Supplement cGMP Rule (21 CFR part 111)

FDA regulates both finished dietary supplement products and dietary ingredients. FDA regulates dietary supplements under a different set of regulations than those covering "conventional" foods and drug products.

Speaker: Thomas E. Colonna | View Anytime | Price: $190.00 | View Details
John E Lincoln

Dietary Supplements CGMPS - 21 CFR 111 Compliance

21 CFR part 111 ("the DS CGMP rule") requires persons who manufacture, package, label, or hold a dietary supplement to establish and follow current good manufacturing practice-the CGMPs. This is to ensure the quality of the dietary supplement and to ensure that the dietary supplement is packaged and labeled as specified in the master manufacturing record.

Speaker: John E Lincoln | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Stephanie Cooke

Good Manufacturing Practices for Phase I Investigational Drug Products: GMPs Required for Drug Products Used in Phase I Clinical Trials

Phase I clinical trials are the first time that investigational new drugs are introduced into human subjects and, although it is very, very important for all drugs to be manufactured using GMPs, it is probably more important than at any other time during the lifecycle of the product, that a product be safe whenever humans are being exposed to it for the first time. In any stage during the lifecycle of the drug product, a product is considered adulterated and therefore, illegal for sale, if it is not manufactured using good manufacturing practices.

Speaker: Stephanie Cooke | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Danielle DeLucy

Batch Record Review and Product Release

Most Regulatory Agencies require firms to have written procedures in place to document production and process controls, better known as batch records. Additionally, there must be written procedures for a batch record review process that demonstrate compliance.

Speaker: Danielle DeLucy | View Anytime | Price: $190.00 | View Details
Susanne Manz

Non-Conforming Material and Failure Investigation

Non-conforming material happens. And medical device companies must deal it. This 90-minute webinar will help you to make sense of confusing regulations and effectively deal with non-conforming material. You'll learn how to identify, segregate, control, and disposition non-conforming material. You'll learn about conducting failure investigations and requirements for correction and corrective action. Join industry expert, Susanne Manz from Manz Consulting Inc, to learn the essentials of dealing with non-conforming material.

Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Susanne Manz

Death by CAPA - Does your Company have the Symptoms?

CAPA is the foundation of an effective Quality Management System. Yet, many companies suffer from a slow, bureaucratic, ineffective CAPA process. Not only do they fail to achieve necessary improvements, they waste precious time and resources. This webinar will help you avoid those struggles and establish an efficient and effective CAPA process leading to improved quality and compliance for your company. You'll learn how to streamline and monitor your process to ensure compliance and improved performance. If your CAPA process needs a CAPA, this webinar is for you.

Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
David Ringstrom

Master Excel: Introduction to Pivot Tables - Part 1

You will learn the basics of creating and using Excel pivot tables in this valuable webcast presented by Excel expert David Ringstrom, CPA. Pivot tables allow you to create reports from complex data simply by using your mouse. Pivot tables have a few nuances that can trip up the unaware user, so David points out the traps and shares tricks that will help ensure the reports you create are accurate.

Speaker: David Ringstrom | View Anytime | Price: $190.00 | View Details
Angela Bazigos

European Data Protection Regulation - 2018 Implementation

On 4 May 2016, the official texts of the Regulation and the Directive have been published in the EU Official Journal in all the official languages. While the Regulation will enter into force on 24 May 2016, it shall apply from 25 May 2018. The Directive enters into force on 5 May 2016 and EU Member States have to transpose it into their national law by 6 May 2018.

Speaker: Angela Bazigos | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Ginette Collazo

Controlling Human Error in the Manufacturing Floor

Human error is known to be the major cause of quality and production losses in many industries. Although it is unlikely that human error will ever be totally eliminated, many human performance problems can be prevented. Human errors start at the design stage. From procedures, training, and workplace environment many variables that affect human behavior CAN be manipulated reducing the likelihood of these occurrences. To work with these challenges it is really important to understand human behavior and the psychology of error as well as understand exactly where the systems weaknesses are, so they can be improved and/or fixed. This course offers practical approaches and models to address human performance issues in GMP related environments by using a specific methodology to correct, prevent and avoid re-occurrence of these issues.

Speaker: Ginette Collazo | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Robert J. Russell

Latin America Regulatory Compliance: Current Challenges in Argentina, Brazil and Mexico

The Latin America Regulatory compliance requirement training/webinar will cover topics across the full Life-Cycle of Company & Product licensing in the key markets of Latin America. Written Regulations vs. Skillful Negotiation will be explained across every critical topic. The importance of local resources, Agency meetings and knowing how to navigate the regulatory landscape will accelerate country establishment and successful product licensing.

Speaker: Robert J. Russell | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Anna Longwell

Laboratory-Developed Tests: Why does FDA think they Can Regulate them, and why do Others think they Cannot

This presentation will review the legal definition of medical device, and how it is applied by FDA to in vitro diagnostic tests. It will review the history of FDA interest in LDTs, and will describe the current situation with respect to Laboratory-developed tests. It will describe tests which have been cleared by FDA and those which have attempted clearance but not been cleared. It will discuss possible future actions by FDA and by the US laboratory community and assess their probability.

Speaker: Anna Longwell | View Anytime | Price: $190.00 | View Details
John N. Zorich

Valid Statistical Rationales for Sample Sizes

This webinar explains the logic behind sample-size choice for several statistical methods that are commonly used in verification or validation efforts, and how to express a valid statistical justification for a chosen sample size.

Speaker: John N. Zorich | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Steven S. Kuwahara

GMP Expectations for Products Used in Early Phase IND Studies

FDA issued a guidance document covering GMP requirements for Phase 1 products. These guidelines remove some of the problems that are encountered with early phase products and are in addition to those that cover the CMC sections for IND submissions at Phase 1.

Speaker: Steven S. Kuwahara | View Anytime | Duration: 75 Minutes | Price: $190.00 | View Details
Louis Angelucci

2011 FDA Guideline on Process Validation

The FDA in 2011 instituted its latest interpretation. Many have not chosen to take it seriously or change their business model. The paradigm has shifted and this presentation will articulate what has changed and how we need to react. Validation as derived from industry practice has a new spin. This presentation will take you through that development and demonstrate how some in the industry have reacted to the new expectations.

Speaker: Louis Angelucci | View Anytime | Price: $190.00 | View Details
Angela Bazigos

FDA's Enforcement of 21 CFR Part 11 Compliance

This presentation will cover the scope, status and results of the surveillance inspections and what they may mean for the future of 21 CFR Part 11. This will enable you to determine whether your company is subject to the most common violations so you can take action to have a better inspection outcome.

Speaker: Angela Bazigos | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Angela Bazigos

Key Factors to Write an Effective Standard Operating Procedure (SOP) and Work Instructions (WIs)

This webinar will instruct the participant on how to write, organize, and maintain SOPs and train personnel in a way that will ensure compliance in a way that is concise, reproducible and easy to follow. It will begin with a strategic view of SOPs in a company and how SOPs can help streamline operations in addition to ensuring regulatory compliance.

Speaker: Angela Bazigos | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Angela Bazigos

Excel Spreadsheet Validation for FDA 21 CFR Part 11

This webinar will describe the regulatory and business requirements for Excel spreadsheets, using examples from FDA recommendations. It will then cover the design and installation of those Excel Spreadsheets, to ensure the integrity of the data, and will discuss how to ensure 21 CFR 11 compliance during the development, installation and maintenance of a spreadsheet application.

Speaker: Angela Bazigos | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
John E Lincoln

Design History Files (DHF), Device Master Records (DMR), Device History Records (DHR), Technical Files , Design Dossiers - The Requirements

It will also consider the European Union's MDD TF/DD requirements, and evaluate the documents' differing purposes / goals, as well as the two different device classification schemes. Required and desirable contents will be discussed.

Speaker: John E Lincoln | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
John E Lincoln

CAPA, Failure Investigation and Root Cause Analysis to Meet FDA Expectations

Defined Failure Investigation and Root Cause Analysis is a major tool in product complaint, non-conformance, and OOS failure investigations, and hazard analysis / risk management and mitigation activities, the basic foundation of a viable CAPA system.

Speaker: John E Lincoln | View Anytime | Price: $190.00 | View Details
David R Dills

Complaint Handling and Management: From Receipt to Trending

An effective complaint handling system is an extremely important part of any quality system. Manufacturers should understand that any complaint received on a product shall be evaluated and, if necessary, thoroughly investigated and analyzed, and corrective action shall be taken.

Speaker: David R Dills | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Steven S. Kuwahara

Auditing Analytical Laboratories for FDA Compliance

Auditing analytical laboratories can be complex because of the preparation that is often required. All of the GMP rules do not apply to the laboratory; while there may be additional requirements depending upon the type of testing that is being conducted. In many cases, the laboratory itself may not understand what regulations apply to the work that is being conducted.

Speaker: Steven S. Kuwahara | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Betty Lane

Effective Root Cause Analysis: The Key to an Effective Corrective Actions System

In this presentation you will learn the importance of root cause analysis and how it fits into an effective corrective and preventive action system. There will be a review of the principles of Corrective and Preventive Action. Risk Management is a current FDA hot topic, and Root cause analysis and Risk Management are intimately connected, and using risk management principles while doing root cause analysis is not only smart but cost effective.

Speaker: Betty Lane | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Thomas Bento

The Value of a Human Factors Program

This webinar will explain the implementation of ISO 62366 and the regulatory expectations discussed in the 2016 FDA Guidance for a compliant human factors/ usability program.

Speaker: Thomas Bento | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Dennis Taylor

Mastering Excel 2013 Pivot Tables

PivotTable capabilities are enormous; among its many tools and features.

Speaker: Dennis Taylor | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Dennis Taylor

Time-Saving Excel Tips, Tricks and 100 Shortcuts

Microsoft Excel has a tremendous amount of capability and features and is filled with shortcuts and methods not always visible to the casual user. Whether it's a keystroke shortcut or a hidden command sequence, such shortcuts can make you much more proficient and productive as you use this powerful and popular software.

Speaker: Dennis Taylor | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Jeff Kasoff

How FDA Trains its Investigators to Review CAPA and What you Should do to Prepare

Year after year, CAPA is the subsystem cited most frequently during FDA inspections. During an inspection, FDA personnel will take a great deal of time reviewing your company's CAPA system. What will they look for? This session will discuss techniques used by the FDA to review your CAPA system. The documents used by FDA to train their inspectors to review your CAPA system will be explained, some of which you may not be familiar with. Also contained in this session will be a section-by-section summary of the CAPA subsection of the QSIT, the document by which FDA inspectors operate during an inspection, as well as how your company can use that same document to increase the likelihood of a positive outcome during the inspection.

Speaker: Jeff Kasoff | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Danielle DeLucy

Handling OOS Test Results and Completing Robust Investigations

This webinar will review the regulatory requirements for investigating an OOS Investigation. The responsibilities of the analyst, the supervisor and QA will be discussed. A detailed flow chart will be used to help the attendees clearly understand the steps and the order in which they are to be performed. The structure of an Investigation report which properly documents the investigation will be discussed.

Speaker: Danielle DeLucy | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Jeff Kasoff

Supplier Evaluation and Assessment: How to Meet FDA QSR and ISO 13485 Requirements in a Cost-Effective Manner

A lack of adequate control over purchases has resulted in a significant number of recalls due to component failures. Since FDA does not directly regulate component suppliers, it is imperative that your company's purchasing and supplier control requirements provide the assurance that only acceptable components are used to manufacture finished devices. Most medical device manufacturers have acceptable systems in place to assure component quality. But what about supplier quality? Your company must have procedures in place that describe the methods you use to evaluate potential suppliers, and set forth requirements that your suppliers must meet to be considered 'approved.' You must also have a system in place to routinely assess your suppliers, and set forth the applicable criteria they must meet to remain 'approved.' You may never have to pay a visit to your supplier if you have a good supplier control program in place.

Speaker: Jeff Kasoff | View Anytime | Price: $190.00 | View Details
Jeff Kasoff

Complaint Handling in Compliance with FDA and ISO Regulations

Negative customer feedback about a medical device's performance or safety is a strong indicator of whether a firm's manufacturing process is in control. This feedback is therefore subject to many requirements in both the QSR and ISO 13485. Failure to follow up on complaints about medical devices is among the most frequently cited observations on FDA-483s.

Speaker: Jeff Kasoff | View Anytime | Price: $190.00 | View Details
Robert J. Russell

Japan - Regulatory Filing Requirements and Compliance Processes for Life Sciences

This course specifically focuses on the overall regulatory compliance requirements and procedures for Pharmaceuticals, Medical Devices, Biologics and Combination Products in Japan. The course will cover topics relating to pre-clinical and clinical requirements, as well as, addressing the structure of the regulatory agencies in Japan. Content will also include descriptions of the methods by which regulators in the corresponding agencies process filings and registrations and what is expected in the authorization and dossier maintenance of licensed products.

Speaker: Robert J. Russell | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Robert J. Russell

Drug Master Files: Understanding and Meeting your Regulatory and Processing Responsibilities

This combined Quality Agreement and DMF (Drug Master Files) training will discuss the advantages for suppliers and drug product manufacturers developing these arrangements together.

Speaker: Robert J. Russell | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
John N. Zorich

Better Alternatives to AQL Sampling Plans for Risk Management in Incoming QC

The pros and cons of the 2 most widely used sampling plans (ANSI Z1.4, and Squeglia's C=0) are examined in detail, focusing especially on the weaknesses of such plans in regards to meeting regulatory requirements. Real-world examples are provided for how using such sampling plans leads to production of non-conforming product.

Speaker: John N. Zorich | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Edwin Waldbusser

Software Validation for the New FDA Inspections

This course will teach how to conduct a software validation program that will satisfy FDA requirements and produce a safe product. We will explain the role of risk analysis in validation. How software requirements are used in validation will be described. This course is NOT a programming course. We will discuss what must be done but will not discuss methods to execute necessary testing.

Speaker: Edwin Waldbusser | View Anytime | Price: $190.00 | View Details
Edwin Waldbusser

21 CFR Part 11 - Compliance for Electronic Records and Signatures

This webinar details the regulation and how it applies to computerized systems.

Speaker: Edwin Waldbusser | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Teri C. Soli

Water System Mythology: Common False Beliefs for Microbial Control and Monitoring

It is an unfortunate fact that most water systems today have been designed and are operated and controlled using at least some traditional concepts and methods that are downright wrong. So how could such traditions become so ingrained and be so wrong? How could well-intentioned benchmarking be so misguided?

Speaker: Teri C. Soli | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Thomas E. Colonna

FDA Regulation of Dietary Supplements

FDA regulates both finished dietary supplement products and dietary ingredients. FDA regulates dietary supplements under a different set of regulations than those covering "conventional" foods and drug products. Under the Dietary Supplement Health and Education Act of 1994 (DSHEA).

Speaker: Thomas E. Colonna | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Dr. Ludwig Huber

Validation and Use of Excel® Spreadsheets in FDA Regulated Environments

Excel® Applications are widely used in laboratories, offices and manufacturing e.g., for data capture, data manipulation and report generation.

Speaker: Dr. Ludwig Huber | View Anytime | Duration: 75 Minutes | Price: $190.00 | View Details
Casper Uldriks

FDA's New Import Program for 2017

The FDA and U.S. Customs and Border Protection are using new import requirements. The FDA's import software screening program (PREDICT) and the U.S. Custom's ACE software program require more information from the foreign source(s). FDA's product codes and U.S. Harmonized Tariff Schedule (HTS) link the requirements. The software coding information must be correct. Otherwise, you face costly delays and possibly a refusal of the entry. In addition, information on the entry's commercial or pro forma invoice must be consistent with the information entered into PREDICT and ACE software. FDA offers some relief from the strict requirements if you participate in a voluntary Affirmation of Compliance (AOC). Providing accurate information is necessary in order to reconcile the PREDICD, ACE, Invoice and AOC information. Your failure to accomplish these tasks can lead to smooth sailing or to a whirlpool of costly delays and fines. Time is not on your side during the import process. Time is money; the more you use, the more you lose.

Speaker: Casper Uldriks | View Anytime | Price: $190.00 | View Details
Dr. Ludwig Huber

New FDA, EMA and USP Guidelines for Transfer of Analytical Methods

When validated methods are transferred between laboratories and sites, their validated state should be maintained to ensure the same reliable results in the receiving laboratory. For a long time there was no official guidance on what exactly is expected to maintain 'the validated state'. Now the USP has published an updated general chapter <1224>. Also the FDA has released an official guidance on how to conduct and document method transfer. In addition the FDA has included requirements for method transfer in its new guidance from 2015 on validation of analytical methods. And last but not least Europe has released an updated GMP Chapter 6 with clear requirements for comparative testing and acceptance criteria. This Webinar will give a good understanding of USP, FDA and EU requirements and provide recommendations and tools for effective implementation.

Speaker: Dr. Ludwig Huber | View Anytime | Duration: 75 Minutes | Price: $190.00 | View Details
Dr. Ludwig Huber

Understanding the USP Chapter 1224 for Transfer of Analytical Methods

When validated methods are transferred between laboratories and sites, their validated state should be maintained to ensure the same reliable results in the receiving laboratory.

Speaker: Dr. Ludwig Huber | View Anytime | Duration: 75 Minutes | Price: $190.00 | View Details
Dr. Ludwig Huber

FDA's New Enforcement of 21 CFR Part 11

FDA continues to enforce Part 11 through its new Part 11 inspection and enforcement program. Just in the last 3 years, FDA issued more than 30 warning letters with Part 11 violations. Citations are related to inadequate integrity, security and availability of electronic records but also related to validation of software and computer systems. There are many questions about the program, e.g., what inspectors are looking at what are major findings.

Speaker: Dr. Ludwig Huber | View Anytime | Duration: 75 Minutes | Price: $190.00 | View Details
Karl J Hemmerich

Accelerated Aging Techniques for Medical Device Products

Accelerated aging (AA) is testing that uses aggravated conditions of heat, oxygen, sunlight, vibration, chemicals, etc. to speed up the normal aging processes of items. It is used to help determine the long-term effects of expected levels of stress within a shorter time, usually in a laboratory by controlled standard test methods.

Speaker: Karl J Hemmerich | View Anytime | Price: $190.00 | View Details
Mike Thomas

OneNote - Bringing Order to your Digital Chaos

OneNote is a digital notebook. It is available for Windows, Mac and mobile. Use it to capture, store and organise your ideas and information. OneNote notes can store text, images, videos, embedded files and even drawings and sketches. OneNote notebooks can be shared with colleagues and customers, in fact anyone, making it the perfect platform for collaborative work. Use OneNote to manage your projects. Use OneNote to manage your meetings. Use OneNote to manage your life.

Speaker: Mike Thomas | View Anytime | Price: $190.00 | View Details
Mike Thomas

Mastering Excel Formulas and Functions

Using formulas turns Excel into the world's most powerful calculator. Whether you need to calculate loan repayments, generate a profit and loss account, solve maths or engineering problems, in fact, think of any scenario that involves addition, subtraction, division or multiplication of numbers and you'll find that Excel is the best tool for the job.

Speaker: Mike Thomas | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Mike Thomas

Get Organised with Microsoft Outlook

If you're like millions of other business professionals, you probably use Microsoft Outlook every day to manage your email, calendar and to do's. It's available for Windows, Mac, mobile and there's even a web version. So there's no excuse not to be organised. Or so the theory goes. The reality is email overload, missed deadlines and calendars so full you have no room to breathe

Speaker: Mike Thomas | View Anytime | Price: $190.00 | View Details
Roger Cowan

Pharmaceutical Compressed Air - Quality GMP Requirements - What you need to know to Meet FDA and International Quality Standards

Compressed air for pharmaceutical use is considered a critical utility as many of its applications involve direct contact with the pharmaceutical product. The design, construction and monitoring of a compressed air system is essential for maintaining a quality system without contamination of the product. Proper testing of compressed air quality according to international standards is important for both validation and ongoing monitoring of the system.

Speaker: Roger Cowan | View Anytime | Price: $190.00 | View Details
Roger Cowan

HVAC and GMP Environmental Control for Pharmaceutical Clean Rooms

Environmental control of pharmaceutical clean rooms is essential to the manufacture of a quality product. The definition of Environmental Control vs. Environmental Monitoring is discussed. Control of such conditions as airborne particulate, microorganisms, temperature, humidity, differential pressure, airflow, air velocity and personnel is crucial to protect the product from contamination.

Speaker: Roger Cowan | View Anytime | Duration: 75 Minutes | Price: $190.00 | View Details
John C. Fetzer

Analytical Method Validation Under Good Laboratory Practices - GLPs

If you do any work that will be reported to the US Food and Drug Administration (FDA), Environmental Protection Agency (EPA), or Occupational Safety and Health Administration (OSHA), your work must be done under GLP. All methods must be validated, the proof that they do what is claimed. Common criteria are accuracy, precision, linearity, range, and several more.

Speaker: John C. Fetzer | View Anytime | Price: $190.00 | View Details
Charles H Pierce

How to Prevent or Handle Protocol Deviations and Violations to be GCP and Regulatory Compliant

Deviations and Violations from the agreed upon protocol may very well affect the scientific validity of the research. For this reason, a well-written protocol, taking onto account the role of all the Inclusion and Exclusion criteria in subject enrollment is a key element in having deviation free study conduct.

Speaker: Charles H Pierce | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Susanne Manz

Root Cause Analysis for CAPA - Myths, Challenges, and Best Practices

This webinar will help you understand the critical ingredients for conducting an effective root cause analysis. You will learn about FDA expectations, tools and techniques, and tips for conducting and documenting root cause analysis. We will discuss the myths, challenges, and best practices for this critical process. We'll also cover the essentials of doing a failure investigation.

Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Susanne Manz

Essentials of Validation - IQ, OQ, PQ

Validation is an important element of the Quality System Regulations and ISO13485. This course will cover the requirements the essentials of validation. You'll learn about what processes needed to be validated and what steps you need to take to validate processes. You'll learn the essentials of validation planning, protocol writing, and change management.We'll cover the steps of Installation Qualification (IQ),Operational Qualification (OQ), and Performance Qualification (PQ) including tips and best practices.

Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Dr. Ludwig Huber

Understanding and Implementing USP 1058 Analytical Instrument Qualification

Analytical instruments should be qualified to demonstrate suitability for the intended use. Despite the fact that instrument qualification is nothing new and companies spend a lot of time, it is a frequently cited deviation in FDA inspectional observations and warning letters.

Speaker: Dr. Ludwig Huber | View Anytime | Duration: 75 Minutes | Price: $190.00 | View Details
Steven Wachs

Determining Sample Size: What Sample Size Should I Use?

The webinar will provide important considerations when selecting sample sizes for specific applications. The knowledge gained by attending the webinar will allow practitioners to consider the implications of sample size selection prior to conducting the study and ensure that the information obtained can be useful for decision making.

Speaker: Steven Wachs | View Anytime | Duration: 75 Minutes | Price: $190.00 | View Details
Dennis Taylor

Mastering Excel 2013 Pivot Tables

PivotTable capabilities are enormous; among its many tools and features

Speaker: Dennis Taylor | View Anytime | Price: $190.00 | View Details
Susanne Manz

Death By CAPA - Does your CAPA Program Need a CAPA?

This webinar will help you establish an efficient and effective CAPA (Corrective and Preventive Action) process leading to improved quality and compliance for your company. You'll learn how to streamline and monitor your process to ensure compliance and improved performance. If your CAPA process needs a CAPA, this webinar is for you. We will discuss requirements, the myths, and the challenges of managing CAPAs so you can avoid common problems and pitfalls.

Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Dr. Ludwig Huber

Validation and Use of Excel® Spreadsheets in FDA Regulated Environments

Excel® Applications are widely used in laboratories, offices and manufacturing e.g., for data capture, data manipulation and report generation.

Speaker: Dr. Ludwig Huber | View Anytime | Duration: 75 Minutes | Price: $190.00 | View Details
John E Lincoln

Design History Files (DHF), Device Master Records (DMR), Device History Records (DHR), Technical Files , Design Dossiers - The Requirements

It will also consider the European Union's MDD TF/DD requirements, and evaluate the documents' differing purposes / goals, as well as the two different device classification schemes. Required and desirable contents will be discussed.

Speaker: John E Lincoln | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Dennis Taylor

Time-Saving Excel Tips, Tricks and 100 Shortcuts

Microsoft Excel has a tremendous amount of capability and features and is filled with shortcuts and methods not always visible to the casual user. Whether it's a keystroke shortcut or a hidden command sequence, such shortcuts can make you much more proficient and productive as you use this powerful and popular software.

Speaker: Dennis Taylor | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Teri C. Soli

Water System Biofilm Control and Microbial Monitoring Myths

It is an unfortunate fact that most water systems today have been designed and are operated and controlled using at least some traditional concepts and methods that are downright wrong. So how could such traditions become so ingrained and be so wrong? How could well-intentioned benchmarking be so misguided?

Speaker: Teri C. Soli | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Steven Walfish

Using Statistics to Determine Sample Size

This webinar covers the statistical methods used to calculate sample sizes for both attribute and variables data. Methods for collecting the sample will be covered. Every sampling plan has risks. This webinar covers how to calculate Type I and Type II errors. A discussion of how the FDA views sampling plans, especially for validation and acceptance activities. Sample size to ensure a certain level of process capability will be covered.

Speaker: Steven Walfish | View Anytime | Price: $190.00 | View Details
Angela Bazigos

Key Factors to Write an Effective Standard Operating Procedure (SOP) and Work Instructions (WIs)

This webinar will instruct the participant on how to write, organize, and maintain SOPs and train personnel in a way that will ensure compliance in a way that is concise, reproducible and easy to follow. It will begin with a strategic view of SOPs in a company and how SOPs can help streamline operations in addition to ensuring regulatory compliance. This will be followed by explanation on how to get from regulations to the SOP. Finally, Best Practices for creating, implementing and maintaining SOPs using a risk based approach and getting SOPs ready for inspection will be presented.

Speaker: Angela Bazigos | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
John N. Zorich

Valid Statistical Rationales for Sample Sizes

This webinar explains the logic behind sample-size choice for several statistical methods that are commonly used in verification or validation efforts, and how to express a valid statistical justification for a chosen sample size.

Speaker: John N. Zorich | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
John N. Zorich

Better Alternatives to AQL Sampling Plans for Risk Management in Incoming QC

The pros and cons of the 2 most widely used sampling plans (ANSI Z1.4, and Squeglia's C=0) are examined in detail, focusing especially on the weaknesses of such plans in regards to meeting regulatory requirements. Real-world examples are provided for how using such sampling plans leads to production of non-conforming product.

Speaker: John N. Zorich | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Angela Bazigos

3-hour Virtual Seminar on Analytical Method Validation Process

Use of analytical methods is widespread. However, there are no formally accepted guideline or formats for the overall process of design, development, optimization & validation of analytical methods.Many analytical methods, lacking full and adequate validation have been introduced into the open literature and allowed to assume aura of authenticity but, they may never work or be useful with samples that are typically encountered.

Speaker: Angela Bazigos | View Anytime | Duration: 3 Hours | Price: $340.00 | View Details
Ginette Collazo

Controlling Human Error in the Manufacturing Floor

Human error is known to be the major cause of quality and production losses in many industries. Although it is unlikely that human error will ever be totally eliminated, many human performance problems can be prevented. Human errors start at the design stage. From procedures, training, and workplace environment many variables that affect human behavior CAN be manipulated reducing the likelihood of these occurrences. To work with these challenges it is really important to understand human behavior and the psychology of error as well as understand exactly where the systems weaknesses are, so they can be improved and/or fixed. This course offers practical approaches and models to address human performance issues in GMP related environments by using a specific methodology to correct, prevent and avoid re-occurrence of these issues.

Speaker: Ginette Collazo | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Carol Friedhoff

Key Steps to Successful Project Management Principles

A project is a temporary endeavor undertaken to create a unique product, service or result. Project management is the application of knowledge, skills, tools and techniques to project activities to meet the project requirements. Companies have come to recognize the importance of project management in helping them achieve their objectives and have added this to their organizational structure. Project management started with the construction industry and has evolved over time.

Speaker: Carol Friedhoff | View Anytime | Price: $190.00 | View Details
Karl J Hemmerich

Accelerated Aging Techniques for Medical Device Products

Accelerated aging (AA) is testing that uses aggravated conditions of heat, oxygen, sunlight, vibration, chemicals, etc. to speed up the normal aging processes of items. It is used to help determine the long-term effects of expected levels of stress within a shorter time, usually in a laboratory by controlled standard test methods.

Speaker: Karl J Hemmerich | View Anytime | Price: $190.00 | View Details
Heath Suddleson

Managing Client Expectations Without Losing your Shirt or the Next Job

This course will help participants examine issues on the project from multiple viewpoints. While a General Contractor certainly has one perspective on the project, so too do the Owner, Architect/Engineer, Subcontractors, and other Stakeholders. By learning to present issues in the right framework we decrease adversarial behaviors on the project and increase the likelihood that our proposals for additional work will be accepted.

Speaker: Heath Suddleson | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Edwin Waldbusser

How to Prepare for and Host a FDA Inspection and Respond to 483's

In this webinar you will learn about the types of FDA inspections, preparations such as assigning dedicated personnel to specific tasks for the inspection, facility requirements to support the inspection ( front room, back room), the value of mock audits, how personnel should conduct themselves, the inspection process and how to respond to 483s and warning letters.

Speaker: Edwin Waldbusser | View Anytime | Price: $190.00 | View Details
Jose Mora

Design History File (DHF), the Device Master Record (DMR) and the Device History Record (DHR) - Principles on Lean Documents and Lean Configuration

Design History Files (DHF), Device Master Records (DMR), and Device History Records (DHR) are key building blocks used in the design, development, manufacturing, and cGMP compliance for the Medical Device Industry. Too often, these are cluttered, confusing, and cause many errors due to the way they are created, organized, and managed.

Speaker: Jose Mora | View Anytime | Price: $190.00 | View Details
Robert J. Russell

Latin America Regulatory Compliance: Current Challenges in Argentina, Brazil and Mexico

The Latin America Regulatory compliance requirement training/webinar will cover topics across the full Life-Cycle of Company & Product licensing in the key markets of Latin America. Written Regulations vs. Skillful Negotiation will be explained across every critical topic. The importance of local resources, Agency meetings and knowing how to navigate the regulatory landscape will accelerate country establishment and successful product licensing.

Speaker: Robert J. Russell | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Robert J. Russell

Japan - Regulatory Filing Requirements and Compliance Processes for Life Sciences

This course specifically focuses on the overall regulatory compliance requirements and procedures for Pharmaceuticals, Medical Devices, Biologics and Combination Products in Japan. The course will cover topics relating to pre-clinical and clinical requirements, as well as, addressing the structure of the regulatory agencies in Japan. Content will also include descriptions of the methods by which regulators in the corresponding agencies process filings and registrations and what is expected in the authorization and dossier maintenance of licensed products.

Speaker: Robert J. Russell | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Brian Shoemaker

Standards for Medical Device Software: Friend, not Foe

With various changes to standards and regulations, it is important to understand the criteria for compliance, this is your DIY guide to the changes in standards, specifically covering the IEC 62304 standard.

Speaker: Brian Shoemaker | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Brian Shoemaker

Agile for Medical Devices: More than Just Software

Trying to understand the "Agile method" as just another software development lifecycle, with specific rules and a fixed outline, is mistaken, and seriously limits the benefits that Agile can bring. Successful Agile implementations include development, operations and business functions right from the outset. Anything less just creates another process island and cross function friction. All functions must participate actively throughout development, since development is recognized to require learning and adapting (and market needs can change rapidly).

Speaker: Brian Shoemaker | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Casper Uldriks

FDA's New Import Program for 2017

The FDA and U.S. Customs and Border Protection are using new import requirements. The FDA's import software screening program (PREDICT) and the U.S. Custom's ACE software program require more information from the foreign source(s). FDA's product codes and U.S. Harmonized Tariff Schedule (HTS) link the requirements. The software coding information must be correct. Otherwise, you face costly delays and possibly a refusal of the entry. In addition, information on the entry's commercial or pro forma invoice must be consistent with the information entered into PREDICT and ACE software. FDA offers some relief from the strict requirements if you participate in a voluntary Affirmation of Compliance (AOC). Providing accurate information is necessary in order to reconcile the PREDICD, ACE, Invoice and AOC information. Your failure to accomplish these tasks can lead to smooth sailing or to a whirlpool of costly delays and fines. Time is not on your side during the import process. Time is money; the more you use, the more you lose.

Speaker: Casper Uldriks | View Anytime | Price: $190.00 | View Details
Casper Uldriks

Medical Device Cybersecurity : The Landscape of Quicksand

Device cybersecurity programs protect and the performance of device based software or standalone software to assure the safe use of the device. The development and implementation of cybersecurity programs in the device industry requires the use of the FDA's premarket and postmarket information requirements to get to market and to stay on the market. The FDA relies on the use of voluntary standards developed by the National Institute of Standards and Technology (NIST) and voluntary information sharing organizations to meet cybersecurity challenges. Manufacturers have additional business issues to address, such as recovery and public disclosure of cyberattacks, especially when private medical records are extracted, which leads to fines in the millions of dollars per intrusion.

Speaker: Casper Uldriks | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Carolyn Troiano

FDA's New Draft Guidance on Software and Device Changes and the 510(k)

The first guidance document clarifies key terms and provides insight as to how a risk assessment can help medical device manufacturers to evaluate whether a new 510(k) is required. Examples of device changes and recommendations for documenting a company's decisions are provided. FDA provides a series of flowcharts and questions that can serve to guide medical device manufacturers to come to a conclusion as to whether a new 501(k) is necessary. The flowcharts address changes to:

Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Carolyn Troiano

21 CFR Part 11 Compliance for Computer Systems Regulated by FDA

The Webinar will focus on the importance of ensuring that electronic record/electronic signature (ER/ES) capability built into FDA-regulated computer systems meets compliance with 21 CFR Part 11. This includes development of a company philosophy and approach, and incorporating it into the overall computer system validation program and plans for individual systems that have this capability. FDA's 21 CFR Part 11 was enacted in the late 1990s and implementation success across the pharmaceutical and other regulated industries has been mixed. There are very specific limitations that arise when using ER/ES capability, such as the elimination of print capability to prevent users from making decisions based on a paper record as opposed to the electronic record. It also requires very specific identification of users that ensures the person signing the record is the same person whose credentials are being entered and verified by the system. Rule for changing passwords must be rigorously adhered to and the passwords must be kept secure.

Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Carolyn Troiano

FDA Compliance and Mobile Applications

This topic is focused on the use of mobile applications to process data regulated by FDA. These applications may be used to collect, analyze, transfer, report, or otherwise manage data that will be submitted to FDA and/or must be available for FDA review upon inspection or audit. Mobile applications may be used in any area of an FDA-regulated company. Functional areas where FDA-regulated data is typically processed include, but are not limited to Quality Laboratories, Manufacturing, Supply Chain/Distribution, Adverse Event Reporting, Post-Marketing Surveillance. Systems may also be used to monitor and/or control FDA-regulated processes and equipment, handle product labeling, product lot control, clinical trial and trial sample management, and many other processes.

Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Jeff Kasoff

How FDA Trains its Investigators to Review CAPA and What you Should do to Prepare

Year after year, CAPA is the subsystem cited most frequently during FDA inspections. During an inspection, FDA personnel will take a great deal of time reviewing your company's CAPA system. What will they look for? This session will discuss techniques used by the FDA to review your CAPA system. The documents used by FDA to train their inspectors to review your CAPA system will be explained, some of which you may not be familiar with. Also contained in this session will be a section-by-section summary of the CAPA subsection of the QSIT, the document by which FDA inspectors operate during an inspection, as well as how your company can use that same document to increase the likelihood of a positive outcome during the inspection.

Speaker: Jeff Kasoff | View Anytime | Price: $190.00 | View Details
Angela Bazigos

Excel Spreadsheet Validation for FDA 21 CFR Part 11

This webinar will describe the regulatory and business requirements for Excel spreadsheets, using examples from FDA recommendations. It will then cover the design and installation of those Excel Spreadsheets, to ensure the integrity of the data, and will discuss how to ensure 21 CFR 11 compliance during the development, installation and maintenance of a spreadsheet application.

Speaker: Angela Bazigos | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Steven Wachs

Determining Sample Size: What Sample Size Should I Use?

The webinar will provide important considerations when selecting sample sizes for specific applications. The knowledge gained by attending the webinar will allow practitioners to consider the implications of sample size selection prior to conducting the study and ensure that the information obtained can be useful for decision making.

Speaker: Steven Wachs | View Anytime | Duration: 75 Minutes | Price: $190.00 | View Details
Dennis Taylor

Mastering Excel 2013 Pivot Tables

PivotTable capabilities are enormous; among its many tools and features

Speaker: Dennis Taylor | View Anytime | Price: $190.00 | View Details
Louis Angelucci

Similarities and Differences Between an FDA and MHRA Audit

Having participated in both FDA and MHRA audits for the same facility and practices it is interesting that different results and major observations are encountered. In order to meet the expectations of both regulatory bodies we need to review and understand the requirements and approach of both bodies. This webinar will review these and compare some of the similarities and differences.

Speaker: Louis Angelucci | View Anytime | Price: $190.00 | View Details
Dr. Ludwig Huber

Understanding the USP Chapter 1224 for Transfer of Analytical Methods

When validated methods are transferred between laboratories and sites, their validated state should be maintained to ensure the same reliable results in the receiving laboratory.

Speaker: Dr. Ludwig Huber | View Anytime | Duration: 75 Minutes | Price: $190.00 | View Details
John N. Zorich

Better Alternatives to AQL Sampling Plans for Risk Management in Incoming QC

The pros and cons of the 2 most widely used sampling plans (ANSI Z1.4, and Squeglia's C=0) are examined in detail, focusing especially on the weaknesses of such plans in regards to meeting regulatory requirements. Real-world examples are provided for how using such sampling plans leads to production of non-conforming product.

Speaker: John N. Zorich | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Susanne Manz

Death By CAPA - Does your CAPA Program Need a CAPA?

This webinar will help you establish an efficient and effective CAPA (Corrective and Preventive Action) process leading to improved quality and compliance for your company. You'll learn how to streamline and monitor your process to ensure compliance and improved performance. If your CAPA process needs a CAPA, this webinar is for you. We will discuss requirements, the myths, and the challenges of managing CAPAs so you can avoid common problems and pitfalls.

Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Dennis Taylor

Time-Saving Excel Tips, Tricks and 100 Shortcuts

Microsoft Excel has a tremendous amount of capability and features and is filled with shortcuts and methods not always visible to the casual user. Whether it's a keystroke shortcut or a hidden command sequence, such shortcuts can make you much more proficient and productive as you use this powerful and popular software.

Speaker: Dennis Taylor | View Anytime | Price: $190.00 | View Details
Teri C. Soli

Water System Biofilm Control and Microbial Monitoring Myths

It is an unfortunate fact that most water systems today have been designed and are operated and controlled using at least some traditional concepts and methods that are downright wrong. So how could such traditions become so ingrained and be so wrong? How could well-intentioned benchmarking be so misguided?

Speaker: Teri C. Soli | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Angela Bazigos

FDA's 21 CFR 11 Add-On Inspections - Recent Updates

In December 2010 FDA started the Part 11 inspection initiative. While originally the initiative was supposed to last 3-6 months, it has now turned into an ongoing program with Part 11 related issues being part of most future inspections. At the beginning of the initiative FDA made it very clear that Part 11 is in effect and is enforced according to the original Part 11 and the Guidance from 2003. In the meantime FDA officials reported about key findings. For example, George Smith who heads up FDA's Part 11 working group gave an update with examples of violations.

Speaker: Angela Bazigos | View Anytime | Duration: 2 Hours | Price: $190.00 | View Details
Dr. Ludwig Huber

Validation and Use of Excel® Spreadsheets in FDA Regulated Environments

Excel® Applications are widely used in laboratories, offices and manufacturing e.g., for data capture, data manipulation and report generation.

Speaker: Dr. Ludwig Huber | View Anytime | Duration: 75 Minutes | Price: $190.00 | View Details
Angela Bazigos

Key Factors to Write an Effective Standard Operating Procedure (SOP) and Work Instructions (WIs)

This webinar will instruct the participant on how to write, organize, and maintain SOPs and train personnel in a way that will ensure compliance in a way that is concise, reproducible and easy to follow. It will begin with a strategic view of SOPs in a company and how SOPs can help streamline operations in addition to ensuring regulatory compliance. This will be followed by explanation on how to get from regulations to the SOP. Finally, Best Practices for creating, implementing and maintaining SOPs using a risk based approach and getting SOPs ready for inspection will be presented.

Speaker: Angela Bazigos | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Steven Walfish

Using Statistics to Determine Sample Size

This webinar covers the statistical methods used to calculate sample sizes for both attribute and variables data. Methods for collecting the sample will be covered. Every sampling plan has risks. This webinar covers how to calculate Type I and Type II errors. A discussion of how the FDA views sampling plans, especially for validation and acceptance activities. Sample size to ensure a certain level of process capability will be covered.

Speaker: Steven Walfish | View Anytime | Price: $190.00 | View Details
John E Lincoln

Device Changes, FDA Changes, and the 510(k)

The majority of medical devices are cleared for marketing in the U.S. by the FDA under the 510(k) process. The FDA holds companies responsible for filing new 510(k)s when one change is major enough to impact safety / effectiveness, or when a series of lesser changes finally reach the "tipping point".

Speaker: John E Lincoln | View Anytime | Price: $190.00 | View Details
Steven S. Kuwahara

Auditing Analytical Laboratories for FDA Compliance

Auditing analytical laboratories can be complex because of the preparation that is often required. All of the GMP rules do not apply to the laboratory; while there may be additional requirements depending upon the type of testing that is being conducted. In many cases, the laboratory itself may not understand what regulations apply to the work that is being conducted.

Speaker: Steven S. Kuwahara | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
John E Lincoln

Design History Files (DHF), Device Master Records (DMR), Device History Records (DHR), Technical Files , Design Dossiers - The Requirements

It will also consider the European Union's MDD TF/DD requirements, and evaluate the documents' differing purposes / goals, as well as the two different device classification schemes. Required and desirable contents will be discussed.

Speaker: John E Lincoln | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Valarie King Bailey

Lean Validation: Leveraging the NIST Cybersecurity Framework for Computer Systems Validation

Computer systems used in highly regulated companies include sensitive and valuable information. Some of this information includes valuable electronic submissions, clinical information, medical device design control records, legal information, and other such information. Recent events have highlighted sophisticated cybersecurity attacks everywhere including the White House.Corporations have been attacked at an alarming rate. What does this mean for computer systems validation?

Speaker: Valarie King Bailey | View Anytime | Price: $190.00 | View Details
Danielle DeLucy

Batch Record Review and Product Release

Most Regulatory Agencies require firms to have written procedures in place to document production and process controls, better known as batch records. Additionally, there must be written procedures for a batch record review process that demonstrate compliance.

Speaker: Danielle DeLucy | View Anytime | Price: $190.00 | View Details
Danielle DeLucy

Implementation and Management of GMP Data Integrity

In recent years, FDA has increasingly observed CGMP violations involving data integrity during CGMP inspections. This is troubling because ensuring data integrity is an important component of industry's responsibility to ensure the safety, efficacy, and quality of drugs, biologics and medical devices. These data integrity-related CGMP violations have led to numerous regulatory actions, including warning letters, import alerts, and consent decrees. Data integrity is the assurance that data records are accurate, complete, intact and maintained within their original context, including their relationship to other data records. This definition applies to data recorded in electronic and paper formats or a hybrid of both.

Speaker: Danielle DeLucy | View Anytime | Price: $190.00 | View Details
Robert J. Russell

Drug Master Files: Understanding and Meeting your Regulatory and Processing Responsibilities

This combined Quality Agreement and DMF (Drug Master Files) training will discuss the advantages for suppliers and drug product manufacturers developing these arrangements together.

Speaker: Robert J. Russell | View Anytime | Price: $190.00 | View Details
Deb Simpson

Change Control,CAPA,Document Control, and Electronic Systems

Change control, is by its nature and scope, is the most significant QMS intersection. Yet there are no specific QMS regulations that clearly define all areas to be considered. Rather, the scope is defined by the products, processes, and related regulations. Document control is an element of change control, as well as one of the feeder systems, and is also an outcome of change control. In process terms, document control can be an input, a process step and an output of the change control process. Document control is a foundational element of the QMS and provides the structure and support for many other elements, including change control and CAPA.

Speaker: Deb Simpson | View Anytime | Price: $190.00 | View Details
Angela Bazigos

Project Management for 21 CFR 11

This class will explain the basic tenets of project management, the basic tenets of 21 CFR 11 compliance for Computer Systems Validation and will show how to marry the two, to deliver on time and on budget while meeting regulatory compliance requirements.

Speaker: Angela Bazigos | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Mike Thomas

Excel - Business Intelligence with Power Pivot and Power Query

Do you work with "Big Data"? Do you import, manipulate and analyze massive datasets in Excel? If so you'll already be familiar with the limitations of Excel. Power Pivot and Power Query, two free addins for Excel, are designed to get you past these limitations, allowing you to import and work with 1-million-plus-row datasets from virtually any source. If you ever need to create pivot tables from multiple datasets, Power Pivot is your friend. No more vlookup. No more multiple consolidation ranges. If you've been frustrated by other limitations of pivot tables then Power Pivot is for you. Simply put, Power Pivot takes pivot tables and data analysis to the next level. If you're a fan of pivot tables, you'll love Power Pivot.

Speaker: Mike Thomas | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Mike Thomas

OneNote - Bringing Order to your Digital Chaos

OneNote is a digital notebook. It is available for Windows, Mac and mobile. Use it to capture, store and organise your ideas and information. OneNote notes can store text, images, videos, embedded files and even drawings and sketches. OneNote notebooks can be shared with colleagues and customers, in fact anyone, making it the perfect platform for collaborative work. Use OneNote to manage your projects. Use OneNote to manage your meetings. Use OneNote to manage your life.

Speaker: Mike Thomas | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Mike Thomas

Mastering Excel Formulas and Functions

Using formulas turns Excel into the world's most powerful calculator. Whether you need to calculate loan repayments, generate a profit-and-loss account, solve maths or engineering problems, in fact, think of any scenario that involves addition, subtraction, division or multiplication of numbers and you'll find that Excel is the best tool for the job. Functions are built-in formulas that have been programmed to perform a specific calculation. They range from the simple such as SUM and AVERAGE (used to calculate the total and average of numbers in a range of cells) to the powerful IF and VLOOKUP. Functions aren't limited to calculating numeric data.

Speaker: Mike Thomas | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
John E Lincoln

Verification vs Validation-Product, Process or Equipment and QMS Software

The verification and validation of regulated software is coming under increased scruinty by the U.S. FDA.This webinar will address the use of the FDA, GAMP, 21 CFR Part 11,"Electronic Records"/"Electronic Signatures", IEC 62304, and other applicable industry software validation models, coupled with the ISO 14971/ICH Q9 Product Risk Management models, to plan, structure, run, and document acceptable software validations.The FDA and other regulatory agencies have stated that software validation can only be accomplished effectively if "risk-based".How can this be done in the "real world".

Speaker: John E Lincoln | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
James E. Russell

Dietary Supplement Regulatory Compliance in the United States: Labeling, Product Claims & Updates from the FDA

The FDA, with assistance from the FTC, has become increasingly aware of the large amount of dietary supplements that have come onto the market since the passage of the Dietary Supplement Health and Education Act in 1994. A growing public demand for supplements, along with a relatively relaxed pre-market approval process, has resulted in a flurry of companies creating and marketing their own dietary supplements in the United States. With FDA beginning to take a stronger stance on Dietary Supplement enforcement, it is important for companies to verify that their products comply with the latest regulations and provisions.

Speaker: James E. Russell | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Casper Uldriks

FDA's New Import Program for 2017

The FDA and U.S. Customs and Border Protection are using new import requirements. The FDA's import software screening program (PREDICT) and the U.S. Custom's ACE software program require more information from the foreign source(s). FDA's product codes and U.S. Harmonized Tariff Schedule (HTS) link the requirements. The software coding information must be correct. Otherwise, you face costly delays and possibly a refusal of the entry. In addition, information on the entry's commercial or pro forma invoice must be consistent with the information entered into PREDICT and ACE software. FDA offers some relief from the strict requirements if you participate in a voluntary Affirmation of Compliance (AOC). Providing accurate information is necessary in order to reconcile the PREDICD, ACE, Invoice and AOC information. Your failure to accomplish these tasks can lead to smooth sailing or to a whirlpool of costly delays and fines. Time is not on your side during the import process. Time is money; the more you use, the more you lose.

Speaker: Casper Uldriks | View Anytime | Price: $190.00 | View Details
John C. Fetzer

Analytical Method Validation Under Good Laboratory Practices - GLPs

If you do any work that will be reported to the US Food and Drug Administration (FDA), Environmental Protection Agency (EPA), or Occupational Safety and Health Administration (OSHA), your work must be done under GLP. All methods must be validated, the proof that they do what is claimed. Common criteria are accuracy, precision, linearity, range, and several more.

Speaker: John C. Fetzer | View Anytime | Price: $190.00 | View Details
John C. Fetzer

HPLC Analytical Method Development and Validation

Instrumental liquid chromatography is an analysis are widely used to determine purity, the impurities, and the degradation products of pharmaceuticals. The focus of most validation work is on the methodology, the standard operating procedure (SOP). But validation of the instrumentation and other associated items of column, solvents, and other reagents and chemicals is also an area of focus in an audit.

Speaker: John C. Fetzer | View Anytime | Price: $190.00 | View Details
John N. Zorich

Understanding, Calculating, and Using Statistical Power

Statistical power is an indicator of the ability of a test of significance to "detect" a practical difference (e.g., between the averages of two products that are being compared). A low power typically means that the sample sizes in the study are too small. Without an analysis of statistical power, a conclusion of "non-significant" is rightfully questionable. Unless power is high, a study may be doomed to failure even before it is begun.

Speaker: John N. Zorich | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
John N. Zorich

Valid Statistical Rationales for Sample Sizes

This webinar explains the logic behind sample-size choice for several statistical methods that are commonly used in verification or validation efforts, and how to express a valid statistical justification for a chosen sample size.

Speaker: John N. Zorich | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Casper Uldriks

Medical Device Cybersecurity : The Landscape of Quicksand

Device cybersecurity programs protect and the performance of device based software or standalone software to assure the safe use of the device. The development and implementation of cybersecurity programs in the device industry requires the use of the FDA's premarket and postmarket information requirements to get to market and to stay on the market. The FDA relies on the use of voluntary standards developed by the National Institute of Standards and Technology (NIST) and voluntary information sharing organizations to meet cybersecurity challenges. Manufacturers have additional business issues to address, such as recovery and public disclosure of cyberattacks, especially when private medical records are extracted, which leads to fines in the millions of dollars per intrusion.

Speaker: Casper Uldriks | View Anytime | Price: $190.00 | View Details
Susanne Manz

Quality is not an Organization

What does Quality mean to you? Is it a noun meaning an attribute or characteristic measured against a standard or customer requirement? Is it a state of product being free from defects? Is it an organization within your company that is responsible for creating inspection standards or a quality system? Or is it something more? It can be something more powerful for your company. It can be a culture of excellence and a management philosophy leading to improved customer satisfaction and business success.

Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Susanne Manz

Essentials of Validation -IQ,OQ,PQ

Validation is an important element of the Quality System Regulations and ISO13485. This course will cover the requirements the essentials of validation.You'll learn about what processes needed to be validated and what steps you need to take to validate processes. You'll learn the essentials of validation planning, protocol writing, and change management.We'll cover the steps of Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) including tips and best practices.

Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Susanne Manz

Addressing CAPA within a Device Quality System

This webinar will help you ensure an efficient and effective CAPA process leading to improved quality and compliance for your company. You’ll learn how to streamline and monitor your process to ensure compliance and improved performance. If your CAPA process needs a CAPA this webinar is for you.

Speaker: Susanne Manz | View Anytime | Price: $190.00 | View Details
Susanne Manz

Secrets to Writing Effective SOPs for Medical Device QMS

Standard Operating Procedures (SOPs) are a critical ingredient in an effective and efficient Quality Management System. SOPs are typically one of the first things an investigator asks for in an inspection. Well written SOPs send a message to the FDA and Notified Bodies that your QMS is complete, accurate, and followed. More importantly, well written SOPs ensure that your personnel can consistently and accurately follow your processes resulting in correct outcomes and quality work.

Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Derk Yntema

GDPR - European Privacy Regulation what and how

The GDPR (General Data Protection Regulation) compels companies that process Personally Identifiable Information (PII) of European citizens to demonstrate their insight in all PII processing going on in their business. After assessment by a Data Protection Officer (DPO), they should implement appropriate organizational and technical controls.

Speaker: Derk Yntema | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Anna Longwell

FDA's Medical Device Clinical Trials Program

The topic is device clinical trials. This term refers to the use of medical products on/in humans, in order to gain useful knowledge about the product. Such knowledge might be required to enable the development of user instructions, better understanding of limitations, evidence of clinical usefulness, or elements of product design that require additional changes.

Speaker: Anna Longwell | View Anytime | Price: $190.00 | View Details
Anna Longwell

Laboratory-Developed Tests: Why does FDA think they can Regulate them, and why do others think they Cannot

This presentation will review the legal definition of medical device, and how it is applied by FDA to in vitro diagnostic tests. It will review the history of FDA interest in LDTs, and will describe the current situation with respect to Laboratory-developed tests. It will describe tests which have been cleared by FDA and those which have attempted clearance but not been cleared. It will discuss possible future actions by FDA and by the US laboratory community and assess their probability.

Speaker: Anna Longwell | View Anytime | Price: $190.00 | View Details
Edwin Waldbusser

21 CFR Part 11 - Compliance for Electronic Records and Signatures

This webinar details the regulation and how it applies to computerized systems.

Speaker: Edwin Waldbusser | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
John E Lincoln

Design History Files (DHF), Device Master Records (DMR), Device History Records (DHR), Technical Files , Design Dossiers - The Requirements

It will also consider the European Union's MDD TF/DD requirements, and evaluate the documents' differing purposes / goals, as well as the two different device classification schemes. Required and desirable contents will be discussed.

Speaker: John E Lincoln | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Susanne Manz

Death By CAPA - Does your CAPA Program Need a CAPA?

This webinar will help you establish an efficient and effective CAPA (Corrective and Preventive Action) process leading to improved quality and compliance for your company. You'll learn how to streamline and monitor your process to ensure compliance and improved performance. If your CAPA process needs a CAPA, this webinar is for you. We will discuss requirements, the myths, and the challenges of managing CAPAs so you can avoid common problems and pitfalls.

Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Dennis Taylor

Time-Saving Excel Tips, Tricks and 100 Shortcuts

Microsoft Excel has a tremendous amount of capability and features and is filled with shortcuts and methods not always visible to the casual user. Whether it's a keystroke shortcut or a hidden command sequence, such shortcuts can make you much more proficient and productive as you use this powerful and popular software.

Speaker: Dennis Taylor | View Anytime | Price: $190.00 | View Details
Teri C. Soli

Water System Biofilm Control and Microbial Monitoring Myths

It is an unfortunate fact that most water systems today have been designed and are operated and controlled using at least some traditional concepts and methods that are downright wrong. So how could such traditions become so ingrained and be so wrong? How could well-intentioned benchmarking be so misguided?

Speaker: Teri C. Soli | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Angela Bazigos

FDA Enforcement of 21 CFR 11 Compliance

FDA continues to enforce Part 11 through its new Part 11 inspection and enforcement program. Just in the last 3 years FDA issued more than 30 warning letters with Part 11 violations. Citations are related to inadequate data integrity, security and availability of electronic records but also related to validation of software and computer systems. However, typically, citations are against the predicate rules, not part 11 itself. This is very confusing and makes it difficult to determine what the FDA is looking for in these inspections.

Speaker: Angela Bazigos | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Dr. Ludwig Huber

Validation and Use of Excel® Spreadsheets in FDA Regulated Environments

Excel® Applications are widely used in laboratories, offices and manufacturing e.g., for data capture, data manipulation and report generation.

Speaker: Dr. Ludwig Huber | View Anytime | Duration: 75 Minutes | Price: $190.00 | View Details
Dr. Ludwig Huber

FDA's New Enforcement of 21 CFR Part 11

FDA continues to enforce Part 11 through its new Part 11 inspection and enforcement program. Just in the last 3 years, FDA issued more than 30 warning letters with Part 11 violations. Citations are related to inadequate integrity, security and availability of electronic records but also related to validation of software and computer systems. There are many questions about the program, e.g., what inspectors are looking at what are major findings.

Speaker: Dr. Ludwig Huber | View Anytime | Duration: 75 Minutes | Price: $190.00 | View Details
Angela Bazigos

Key Factors to Write an Effective Standard Operating Procedure (SOP) and Work Instructions (WIs)

This webinar will instruct the participant on how to write, organize, and maintain SOPs and train personnel in a way that will ensure compliance in a way that is concise, reproducible and easy to follow. It will begin with a strategic view of SOPs in a company and how SOPs can help streamline operations in addition to ensuring regulatory compliance. This will be followed by explanation on how to get from regulations to the SOP. Finally, Best Practices for creating, implementing and maintaining SOPs using a risk based approach and getting SOPs ready for inspection will be presented.

Speaker: Angela Bazigos | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Steven Walfish

Using Statistics to Determine Sample Size

This webinar covers the statistical methods used to calculate sample sizes for both attribute and variables data. Methods for collecting the sample will be covered. Every sampling plan has risks. This webinar covers how to calculate Type I and Type II errors. A discussion of how the FDA views sampling plans, especially for validation and acceptance activities. Sample size to ensure a certain level of process capability will be covered.

Speaker: Steven Walfish | View Anytime | Price: $190.00 | View Details
John E Lincoln

Device Changes, FDA Changes, and the 510(k)

The majority of medical devices are cleared for marketing in the U.S. by the FDA under the 510(k) process. The FDA holds companies responsible for filing new 510(k)s when one change is major enough to impact safety / effectiveness, or when a series of lesser changes finally reach the "tipping point".

Speaker: John E Lincoln | View Anytime | Price: $190.00 | View Details
Steven S. Kuwahara

Auditing Analytical Laboratories for FDA Compliance

Auditing analytical laboratories can be complex because of the preparation that is often required. All of the GMP rules do not apply to the laboratory; while there may be additional requirements depending upon the type of testing that is being conducted. In many cases, the laboratory itself may not understand what regulations apply to the work that is being conducted.

Speaker: Steven S. Kuwahara | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Dr. Ludwig Huber

Understanding and Implementing USP 1058 Analytical Instrument Qualification

Analytical instruments should be qualified to demonstrate suitability for the intended use. Despite the fact that instrument qualification is nothing new and companies spend a lot of time, it is a frequently cited deviation in FDA inspectional observations and warning letters.

Speaker: Dr. Ludwig Huber | View Anytime | Duration: 75 Minutes | Price: $190.00 | View Details
Steven Wachs

Determining Sample Size: What Sample Size Should I Use?

The webinar will provide important considerations when selecting sample sizes for specific applications. The knowledge gained by attending the webinar will allow practitioners to consider the implications of sample size selection prior to conducting the study and ensure that the information obtained can be useful for decision making.

Speaker: Steven Wachs | View Anytime | Duration: 75 Minutes | Price: $190.00 | View Details
Robert J. Russell

Latin America Regulatory Compliance: Current Challenges in Argentina, Brazil and Mexico

The Latin America Regulatory compliance requirement training/webinar will cover topics across the full Life-Cycle of Company & Product licensing in the key markets of Latin America. Written Regulations vs. Skillful Negotiation will be explained across every critical topic. The importance of local resources, Agency meetings and knowing how to navigate the regulatory landscape will accelerate country establishment and successful product licensing.

Speaker: Robert J. Russell | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Dr. Ludwig Huber

Understanding the New USP Chapter 1224 for Transfer of Analytical Methods

When validated methods are transferred between laboratories and sites, their validated state should be maintained to ensure the same reliable results in the receiving laboratory.

Speaker: Dr. Ludwig Huber | View Anytime | Duration: 75 Minutes | Price: $190.00 | View Details
John N. Zorich

Better Alternatives to AQL Sampling Plans for Risk Management in Incoming QC

The pros and cons of the 2 most widely used sampling plans (ANSI Z1.4, and Squeglia's C=0) are examined in detail, focusing especially on the weaknesses of such plans in regards to meeting regulatory requirements. Real-world examples are provided for how using such sampling plans leads to production of non-conforming product.

Speaker: John N. Zorich | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Jonathan M. Lewis

FDA Inspections - Do's and Don'ts

Most federal laws concerning the FDA are part of the Food, Drug and Cosmetic Act which are codified in Title 21 of the United States Code. However, the language in the law and regulations is often very vague and difficult to interpret. Hence, FDA inspections often result in observations and compliance actions that cost manufacturers and marketers of FDA regulated products hundreds of hours and sometimes millions of dollars to address to the satisfaction of the agency.

Speaker: Jonathan M. Lewis | View Anytime | Price: $190.00 | View Details
John E. Grimes

Preventing and Detecting Fraudulent Vendor Disbursements

Companies and other entities, such as non-profit organizations and government agencies, are vulnerable to a wide variety of internal and external fraud schemes.A prevalent fraud that occurs is improper payments to vendors, fictitious vendors, and related party vendors.A dishonest employee can easily manipulate vendor and accounts payable records to facilitate fraudulent disbursements. The Association of Certified Fraud Examiners claims that nearly two thirds of an entity's fraud exposure involve fraudulent disbursements.Due to the prevailing hazard surrounding fraudulent disbursements, it is imperative that an organization's accounting department, internal auditors, external auditors, and fraud examiners undertake an ongoing robust, cost effective, review of the internal controls over the cash disbursement process. Preventing fraudulent disbursements is the goal with a secondary objective of early detection.

Speaker: John E. Grimes | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Karl J Hemmerich

Accelerated Aging Techniques for Medical Device Packaging

Accelerated aging (AA) is testing that uses aggravated conditions of heat, oxygen, sunlight, vibration, chemicals, etc. to speed up the normal aging processes of items. It is used to help determine the long-term effects of expected levels of stress within a shorter time, usually in a laboratory by controlled standard test methods.

Speaker: Karl J Hemmerich | View Anytime | Price: $190.00 | View Details
Robert Michalik

FDA - Legal Writing Skills that Result in Effective Regulatory Submissions

Law school prepares attorneys to condense complex sets of facts into concise, persuasive arguments that achieve client objectives. These writing skills are even more critical when drafting responses and applications to FDA that are predicated on complex scientific and technical arguments.

Speaker: Robert Michalik | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Greg Martin

Understanding and Applying ICH Q3A and Q3B for Control of Impurities in Drug Substances and Drug Products

This course is designed to provide participants with an understanding of the regulatory expectations for controlling impurities and degradants (including DNA reactive/potential genotoxic impurities) in drug substances and drug products. There will be ample opportunity to discuss questions and challenges from the participants.

Speaker: Greg Martin | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Robert J. Russell

Japan - Regulatory Filing Requirements and Compliance Processes for Life Sciences

This course specifically focuses on the overall regulatory compliance requirements and procedures for Pharmaceuticals, Medical Devices, Biologics and Combination Products in Japan. The course will cover topics relating to pre-clinical and clinical requirements, as well as, addressing the structure of the regulatory agencies in Japan. Content will also include descriptions of the methods by which regulators in the corresponding agencies process filings and registrations and what is expected in the authorization and dossier maintenance of licensed products.

Speaker: Robert J. Russell | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Dan OLeary

Statistical Concepts of Process Validation

Process validation is an important element in medical device manufacturing. This presentation looks at the underlying statistical concepts to perform an effective process validation. The presentation examines elements of the FDA regulations for process validation (21 CFR §820.75) as well as the corresponding requirements in ISO 13485:2016.

Speaker: Dan OLeary | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Edwin Waldbusser

How to Prepare for and Host a FDA Inspection and Respond to 483's

In this webinar you will learn about the types of FDA inspections, preparations such as assigning dedicated personnel to specific tasks for the inspection, facility requirements to support the inspection ( front room, back room), the value of mock audits, how personnel should conduct themselves, the inspection process and how to respond to 483s and warning letters.

Speaker: Edwin Waldbusser | View Anytime | Price: $190.00 | View Details
Brian Shoemaker

Implementing Agile in an FDA-Regulated Environment

The Agile approach is well established in other industries adoption of Agile in medical device development has been increasing in the past five years. Experience is showing that both quality and safety are improved when the development team is agile, and that regulatory requirements can still be met. This session will delve into several key areas for applying Agile in the medical device context, including:

Speaker: Brian Shoemaker | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
John N. Zorich

Process Capability Analysis by means of Confidence Reliability Calculations

The webinar begins with a discussion of relevant regulatory requirements, as motivation for calculating "confidence/reliability". Then, some vocabulary and basic concepts are discussed.

Speaker: John N. Zorich | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
John N. Zorich

Understanding, Calculating, and Using Statistical Power

Statistical power is an indicator of the ability of a test of significance to "detect" a practical difference (e.g., between the averages of two products that are being compared). A low power typically means that the sample sizes in the study are too small. Without an analysis of statistical power, a conclusion of "non-significant" is rightfully questionable. Unless power is high, a study may be doomed to failure even before it is begun.

Speaker: John N. Zorich | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Angela Bazigos

21 CFR 11 Compliance for Excel Spreadsheets

In Dec. 2010, the FDA has stepped up enforcement for 21 CFR 11 compliance with spreadsheets being considered as low hanging fruit for FDA inspectional findings. FDA continues to enforce Part 11 through its new Part 11 inspection and enforcement program. Just in the last 3 years FDA issued more than 30 warning letters with Part 11 violations.

Speaker: Angela Bazigos | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Angela Bazigos

FDA Enforcement of 21 CFR 11 Compliance

FDA continues to enforce Part 11 through its new Part 11 inspection and enforcement program. Just in the last 3 years FDA issued more than 30 warning letters with Part 11 violations. Citations are related to inadequate data integrity, security and availability of electronic records but also related to validation of software and computer systems. However, typically, citations are against the predicate rules, not part 11 itself. This is very confusing and makes it difficult to determine what the FDA is looking for in these inspections.

Speaker: Angela Bazigos | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Danielle DeLucy

Successful Supplier Audits

When contemplating the use of a supplier you would normally have many requirements and expectations that must be met. These include technical, regulatory, quality, responsiveness, location, readiness, and those less defined but critical. One of the tools at your disposal to verify the supplier's acceptability is to audit its operation. This webinar is designed to provide the participants a working knowledge of supplier audits. The why, when, who, how, and what of conducting a supplier audit will be reviewed to ensure that your supplier is capable of meeting all of your expectations. This is a first step in selecting the correct supplier to meet your outsourcing needs.

Speaker: Danielle DeLucy | View Anytime | Price: $190.00 | View Details
Danielle DeLucy

Handling OOS Test Results and Completing Robust Investigations

This webinar will review the regulatory requirements for investigating an OOS Investigation. The responsibilities of the analyst, the supervisor and QA will be discussed. A detailed flow chart will be used to help the attendees clearly understand the steps and the order in which they are to be performed. The structure of an Investigation report which properly documents the investigation will be discussed.

Speaker: Danielle DeLucy | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
David R Dills

Bullet Proof 510(k) - Latest FDA Changes to the Process

There are three types of Premarket Notification 510(k)s that may be submitted to FDA: Traditional, Special, and Abbreviated. The Special and Abbreviated 510(k) methods were developed under the "New 510(k) Paradigm" to help streamline the 510(k) review process.

Speaker: David R Dills | View Anytime | Price: $190.00 | View Details
Edwin Waldbusser

Software Validation for the New FDA Inspections

This course will teach how to conduct a software validation program that will satisfy FDA requirements and produce a safe product. We will explain the role of risk analysis in validation. How software requirements are used in validation will be described. This course is NOT a programming course. We will discuss what must be done but will not discuss methods to execute necessary testing.

Speaker: Edwin Waldbusser | View Anytime | Price: $190.00 | View Details
Edwin Waldbusser

21 CFR Part 11 - Compliance for Electronic Records and Signatures

This webinar details the regulation and how it applies to computerized systems.

Speaker: Edwin Waldbusser | View Anytime | Duration: 75 Minutes | Price: $190.00 | View Details
Dennis Taylor

Time-Saving Excel Tips, Tricks and 100 Shortcuts

Microsoft Excel has a tremendous amount of capability and features and is filled with shortcuts and methods not always visible to the casual user. Whether it's a keystroke shortcut or a hidden command sequence, such shortcuts can make you much more proficient and productive as you use this powerful and popular software.

Speaker: Dennis Taylor | View Anytime | Price: $190.00 | View Details
Louis Angelucci

2011 FDA Guideline on Process Validation

The FDA in 2011 instituted its latest interpretation. Many have not chosen to take it seriously or change their business model. The paradigm has shifted and this presentation will articulate what has changed and how we need to react. Validation as derived from industry practice has a new spin. This presentation will take you through that development and demonstrate how some in the industry have reacted to the new expectations.

Speaker: Louis Angelucci | View Anytime | Price: $190.00 | View Details
David Ringstrom

Master Excel: Spreadsheet Internal Controls

Excel expert David Ringstrom, CPA, shows you how to implement internal control features within your Excel spreadsheets in this enlightening presentation. David uses a simple invoice form as a teaching aid to present various ways to control users' actions within Excel spreadsheets and to protect worksheets and workbooks from unauthorized changes. David demonstrates every technique at least twice first, on a PowerPoint slide with numbered steps, and second, in Excel 2016. He'll draw to your attention any differences in Excel 2013, 2010, or 2007 during the presentation as well as in his detailed handouts. David also provides an Excel workbook that includes most of the examples he uses during the webcast.

Speaker: David Ringstrom | View Anytime | Price: $190.00 | View Details
John N. Zorich

Valid Statistical Rationales for Sample Sizes

This webinar explains the logic behind sample-size choice for several statistical methods that are commonly used in verification or validation efforts, and how to express a valid statistical justification for a chosen sample size.

Speaker: John N. Zorich | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
John N. Zorich

Better Alternatives to AQL Sampling Plans for Risk Management in Incoming QC

The pros and cons of the 2 most widely used sampling plans (ANSI Z1.4, and Squeglia's C=0) are examined in detail, focusing especially on the weaknesses of such plans in regards to meeting regulatory requirements. Real-world examples are provided for how using such sampling plans leads to production of non-conforming product.

Speaker: John N. Zorich | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Ginette Collazo

Controlling Human Error in the Manufacturing Floor

Human error is known to be the major cause of quality and production losses in many industries. Although it is unlikely that human error will ever be totally eliminated, many human performance problems can be prevented. Human errors start at the design stage. From procedures, training, and workplace environment many variables that affect human behavior CAN be manipulated reducing the likelihood of these occurrences. To work with these challenges it is really important to understand human behavior and the psychology of error as well as understand exactly where the systems weaknesses are, so they can be improved and/or fixed. This course offers practical approaches and models to address human performance issues in GMP related environments by using a specific methodology to correct, prevent and avoid re-occurrence of these issues.

Speaker: Ginette Collazo | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Robert J. Russell

Latin America Regulatory Compliance: Current Challenges in Argentina, Brazil and Mexico

The Latin America Regulatory compliance requirement training/webinar will cover topics across the full Life-Cycle of Company & Product licensing in the key markets of Latin America. Written Regulations vs. Skillful Negotiation will be explained across every critical topic. The importance of local resources, Agency meetings and knowing how to navigate the regulatory landscape will accelerate country establishment and successful product licensing.

Speaker: Robert J. Russell | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Robert J. Russell

Drug Master Files: Understanding and Meeting your Regulatory and Processing Responsibilities

This combined Quality Agreement and DMF (Drug Master Files) training will discuss the advantages for suppliers and drug product manufacturers developing these arrangements together.

Speaker: Robert J. Russell | View Anytime | Price: $190.00 | View Details
Casper Uldriks

FDA's New Import Program for 2017

The FDA and U.S. Customs and Border Protection are using new import requirements. The FDA's import software screening program (PREDICT) and the U.S. Custom's ACE software program require more information from the foreign source(s). FDA's product codes and U.S. Harmonized Tariff Schedule