• 28
  • October
  • 2020
  • Wednesday
10:00 AM PDT | 01:00 PM EDT

Carrier Food Safety Problems That May Occur during Transportation (FDA-FSMA)

The FDA recommended course includes actual data, costs and examples from transportation tracked and measured operations.

John Ryan John Ryan | Duration:90 Minutes | Price: $150.00 | View Details
  • 28
  • October
  • 2020
  • Wednesday
10:00 AM PDT | 01:00 PM EDT

Classifying Your Products for International Trade: Plain Talk and Understanding

Importers must know how to classify imported products using the Harmonized Tariff Schedule of the United States (HTSUS).

Martin K. Behr, III Martin K. Behr, III | Duration:90 Minutes | Price: $150.00 | View Details
  • 28
  • October
  • 2020
  • Wednesday
10:00 AM PDT | 01:00 PM EDT

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.

John E Lincoln John E Lincoln | Duration:60 Minutes | Price: $150.00 | View Details
  • 29
  • October
  • 2020
  • Thursday
10:00 AM PDT | 01:00 PM EDT

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).

Casper Uldriks Casper Uldriks | Duration:60 Minutes | Price: $150.00 | View Details
  • 29
  • October
  • 2020
  • Thursday
10:00 AM PDT | 01:00 PM EDT

FDA Regulation of Artificial Intelligence/ Machine Learning

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

Edwin Waldbusser Edwin Waldbusser | Duration:60 Minutes | Price: $150.00 | View Details
  • 30
  • October
  • 2020
  • Friday
10:00 AM PDT | 01:00 PM EDT

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.

Charles H. Paul Charles H. Paul | Duration:60 Minutes | Price: $150.00 | View Details
  • 2
  • November
  • 2020
  • Monday
10:00 AM PST | 01:00 PM EST

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.

Susanne Manz Susanne Manz | Duration:60 Minutes | Price: $150.00 | View Details
  • 2
  • November
  • 2020
  • Monday
10:00 AM PST | 01:00 PM EST

Master Excel: Excel Dashboards

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

David Ringstrom David Ringstrom | Duration:60 Minutes | Price: $150.00 | View Details
  • 3
  • November
  • 2020
  • Tuesday
09:00 AM PST | 12:00 PM EST

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.

Ginette Collazo Ginette Collazo | Duration:3 Hours | Price: $290.00 | View Details
  • 3
  • November
  • 2020
  • Tuesday
10:00 AM PST | 01:00 PM EST

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.

Gwendolyn Wise-Blackman Gwendolyn Wise-Blackman | Duration:60 Minutes | Price: $150.00 | View Details
  • 4
  • November
  • 2020
  • Wednesday
10:00 AM PST | 01:00 PM EST

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.

John E Lincoln John E Lincoln | Duration:90 Minutes | Price: $150.00 | View Details
  • 4
  • November
  • 2020
  • Wednesday
10:00 AM PST | 01:00 PM EST

Excel - Using Macros to Automate Repetitive Tasks and Processes

Do you find yourself repeatedly performing the same actions or tasks in your spreadsheets? Do you have a time-consuming Excel-based process that you want to automate?

Mike Thomas Mike Thomas | Duration:60 Minutes | Price: $150.00 | View Details
  • 5
  • November
  • 2020
  • Thursday
10:00 AM PST | 01:00 PM EST

2-Hour Virtual Seminar on The 6 Most Common Problems in FDA Software Validation and Verification

This webinar describes the validation planning process with particular emphasis on avoiding six common pitfalls.

David Nettleton David Nettleton | Duration:2 Hours | Price: $190.00 | View Details
  • 5
  • November
  • 2020
  • Thursday
10:00 AM PST | 01:00 PM EST

Microsoft Excel- Advanced Charting

There's the famous saying, "A Picture is worth a thousand words". Well, that is very true in Microsoft Excel.

Tom Fragale Tom Fragale | Duration:60 Minutes | Price: $150.00 | View Details
  • 6
  • November
  • 2020
  • Friday
10:00 AM PST | 01:00 PM EST

2-Hour Virtual Seminar on Nonresident Alien W-8 & 1042-S Compliance Update

Do you have a plan to deal with IRS demands for backup withholding if you failed to deduct from payments to Nonresident Aliens' (NRAs)? The IRS is working hard to reduce the delinquent tax burden.

Miles Hutchinson Miles Hutchinson | Duration:2 Hours | Price: $190.00 | View Details
  • 10
  • November
  • 2020
  • Tuesday
10:00 AM PST | 01:00 PM EST

Expedite Excel with Hidden Shortcuts

Excel expert David Ringstrom, CPA is fond of stating "Either you work Excel, or it works you!" In this fast-paced presentation David will share over two dozen ways that you can reclaim part of your day from Excel. You'll uncover mouse techniques, keyboard shortcuts, hidden menus, and even ways to create your own custom keyboard shortcuts in Excel.

David Ringstrom David Ringstrom | Duration:60 Minutes | Price: $150.00 | View Details
  • 10
  • November
  • 2020
  • Tuesday
09:00 AM PST | 12:00 PM EST

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.

Susanne Manz Susanne Manz | Duration:3 Hours | Price: $290.00 | View Details
  • 10
  • November
  • 2020
  • Tuesday
10:00 AM PST | 01:00 PM EST

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.

John E Lincoln John E Lincoln | Duration:60 Minutes | Price: $150.00 | View Details
  • 10
  • November
  • 2020
  • Tuesday
10:00 AM PST | 01:00 PM EST

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.

Robert J. Russell Robert J. Russell | Duration:90 Minutes | Price: $150.00 | View Details
  • 10
  • November
  • 2020
  • Tuesday
10:00 AM PST | 01:00 PM EST

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.

Edwin Waldbusser Edwin Waldbusser | Duration:60 Minutes | Price: $150.00 | View Details
  • 11
  • November
  • 2020
  • Wednesday
10:00 AM PST | 01:00 PM EST

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.

John C. Fetzer John C. Fetzer | Duration:60 Minutes | Price: $150.00 | View Details
  • 11
  • November
  • 2020
  • Wednesday
10:00 AM PST | 01:00 PM EST

Applying Statistical Process Control Effectively

Many companies have failed to achieve the potential benefits from the application of statistical process control due to widespread misunderstanding and misapplication of the methods. When misapplied, great improvements in quality and productivity are not achieved. The consequences of the improper application of SPC include: devastating inefficiencies, poor purchasing decisions, a false sense of reality, and processes controlling human behavior rather than the humans controlling process behavior.

Steven Wachs Steven Wachs | Duration:75 Minutes | Price: $150.00 | View Details
  • 11
  • November
  • 2020
  • Wednesday
09:00 AM PST | 12:00 PM EST

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.

Dennis Taylor Dennis Taylor | Duration:60 Minutes | Price: $150.00 | View Details
  • 11
  • November
  • 2020
  • Wednesday
10:00 AM PST | 01:00 PM EST

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.

Roger Cowan Roger Cowan | Duration:60 Minutes | Price: $150.00 | View Details
  • 12
  • November
  • 2020
  • Thursday
10:00 AM PST | 01:00 PM EST

Improving Productivity with The Office 365 Suite

As a basic-level user of Microsoft Office, you'd love to reduce the number of "hair-tearing-out" moments. You'd love to be able to do things faster so you can go home on time.

Mike Thomas Mike Thomas | Duration:90 Minutes | Price: $150.00 | View Details
  • 12
  • November
  • 2020
  • Thursday
09:00 AM PST | 012:00 PM EST

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.

Casper Uldriks Casper Uldriks | Duration:3 Hours | Price: $290.00 | View Details
  • 12
  • November
  • 2020
  • Thursday
10:00 AM PST | 01:00 PM EST

Standardizing Transportation Procedures to Control Food Safety and Quality

The course includes activities to help trainees develop a general plan and procedures to standardize and control food quality and safety transportation processes.

John Ryan John Ryan | Duration:60 Minutes | Price: $150.00 | View Details
  • 16
  • November
  • 2020
  • Monday
10:00 AM PST | 01:00 PM EST

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.

Michael Esposito Michael Esposito | Duration:90 Minutes | Price: $150.00 | View Details
  • 16
  • November
  • 2020
  • Monday
10:00 AM PST | 01:00 PM EST

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. The United States-Mexico-Canada Agreement (USMCA), commonly referred to as the "New NAFTA," is essentially “NAFTA 2.0".

Martin K. Behr, III Martin K. Behr, III | Duration:90 Minutes | Price: $150.00 | View Details
  • 17
  • November
  • 2020
  • Tuesday
09:00 AM PST | 12:00 PM EST

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.

Robert J. Russell Robert J. Russell | Duration:3 Hours | Price: $290.00 | View Details
  • 17
  • November
  • 2020
  • Tuesday
10:00 AM PST | 01:00 PM EST

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.

Ginette Collazo Ginette Collazo | Duration:90 Minutes | Price: $150.00 | View Details
  • 17
  • November
  • 2020
  • Tuesday
10:00 AM PST | 01:00 PM EST

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.

John Ryan John Ryan | Duration:60 Minutes | Price: $150.00 | View Details
  • 17
  • November
  • 2020
  • Tuesday
10:00 AM PST | 01:00 PM EST

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.

Gwendolyn Wise-Blackman Gwendolyn Wise-Blackman | Duration:60 Minutes | Price: $150.00 | View Details
  • 18
  • November
  • 2020
  • Wednesday
10:00 AM PST | 01:00 PM EST

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.

Steven Wachs Steven Wachs | Duration:60 Minutes | Price: $150.00 | View Details
  • 18
  • November
  • 2020
  • Wednesday
10:00 AM PST | 01:00 PM EST

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.

Tom Fragale Tom Fragale | Duration:60 Minutes | Price: $150.00 | View Details
  • 19
  • November
  • 2020
  • Thursday
10:00 AM PST | 01:00 PM EST

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.

Susanne Manz Susanne Manz | Duration:90 Minutes | Price: $150.00 | View Details
  • 19
  • November
  • 2020
  • Thursday
10:00 AM PST | 01:00 PM EST

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

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

Miles Hutchinson Miles Hutchinson | Duration:90 Minutes | Price: $150.00 | View Details
  • 20
  • November
  • 2020
  • Friday
10:00 AM PST | 01:00 PM EST

Excel Spreadsheets - Step-By-Step Instructions for Ensuring Data Integrity

This interactive webinar provides explicit details and live demonstration followed by a collaborative workshop that explains how to configure and validate a GxP compliant spreadsheet application.

David Nettleton David Nettleton | Duration:75 Minutes | Price: $150.00 | View Details
  • 23
  • November
  • 2020
  • Monday
10:00 AM PST | 01:00 PM EST

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.

Robert J. Russell Robert J. Russell | Duration:90 Minutes | Price: $150.00 | View Details
  • 23
  • November
  • 2020
  • Monday
10:00 AM PST | 01:00 PM EST

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.

John C. Fetzer John C. Fetzer | Duration:60 Minutes | Price: $150.00 | View Details
  • 23
  • November
  • 2020
  • Monday
10:00 AM PST | 01:00 PM EST

Modeling and Optimizing Process Behavior Using Design of Experiments

This webinar will review the key concepts behind Design of Experiments. A strategy for utilizing sequential experiments to most efficiently understand and model a process is presented. Many common types of experiments and their applications are presented. These include experiments appropriate for screening, optimization, mixtures/formulations, etc. Several important techniques in experimental design (such as replication, blocking, and randomization) are introduced. A Case Study involving optimizing a manufacturing process with multiple responses is presented.

Steven Wachs Steven Wachs | Duration:75 Minutes | Price: $150.00 | View Details
  • 23
  • November
  • 2020
  • Monday
10:00 AM PST | 01:00 PM EST

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.

Martin K. Behr, III Martin K. Behr, III | Duration:90 Minutes | Price: $150.00 | View Details
  • 24
  • November
  • 2020
  • Tuesday
10:00 AM PST | 01:00 PM EST

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.

Mike Thomas Mike Thomas | Duration:60 Minutes | Price: $150.00 | View Details
  • 24
  • November
  • 2020
  • Tuesday
10:00 AM PST | 01:00 PM EST

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.

Ginette Collazo Ginette Collazo | Duration:90 Minutes | Price: $150.00 | View Details
  • 24
  • November
  • 2020
  • Tuesday
10:00 AM PST | 01:00 PM EST

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:

Dennis Taylor Dennis Taylor | Duration:2 Hours | Price: $190.00 | View Details
  • 24
  • November
  • 2020
  • Tuesday
10:00 AM PST | 01:00 PM EST

Responsibilities of the Carrier Under the Final FDA FSMA Rules on the Sanitary Transportation of Human and Animal Foods

This is part 1 of a three part required training resulting from the finalization of new US FDA food transportation laws.

John Ryan John Ryan | Duration:60 Minutes | Price: $150.00 | View Details
  • 24
  • November
  • 2020
  • Tuesday
10:00 AM PST | 01:00 PM EST

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.

Casper Uldriks Casper Uldriks | Duration:60 Minutes | Price: $150.00 | View Details
  • 24
  • November
  • 2020
  • Tuesday
10:00 AM PST | 01:00 PM EST

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).

John E Lincoln John E Lincoln | Duration:60 Minutes | Price: $150.00 | View Details
  • 30
  • November
  • 2020
  • Monday
10:00 AM PST | 01:00 PM EST

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.

Michael Esposito Michael Esposito | Duration:90 Minutes | Price: $150.00 | View Details
  • 30
  • November
  • 2020
  • Monday
10:00 AM PST | 01:00 PM EST

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.

Roger Cowan Roger Cowan | Duration:75 Minutes | Price: $150.00 | View Details
  • 1
  • December
  • 2020
  • Tuesday
10:00 AM PST | 01:00 PM EST

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.

Robert J. Russell Robert J. Russell | Duration:90 Minutes | Price: $150.00 | View Details
  • 3
  • December
  • 2020
  • Thursday
10:00 AM PST | 01:00 PM EST

Data Integrity: Compliance with 21 CFR Part 11, SaaS-Cloud, EU GDPR

This webinar describes exactly what is required for compliance with Part 11 and the European equivalent Annex 11 for local, SaaS/Cloud hosted applications.

David Nettleton David Nettleton | Duration:90 Minutes | Price: $150.00 | View Details
  • 3
  • December
  • 2020
  • Thursday
10:00 AM PST | 01:00 PM EST

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.

Mike Thomas Mike Thomas | Duration:60 Minutes | Price: $150.00 | View Details
  • 3
  • December
  • 2020
  • Thursday
10:00 AM PST | 01:00 PM EST

INCOTERMS 2020 Made Easy - Decoding your Shipment

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

Martin K. Behr, III Martin K. Behr, III | Duration:90 Minutes | Price: $150.00 | View Details
  • 7
  • December
  • 2020
  • Monday
10:00 AM PST | 01:00 PM EST

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.

Michael Esposito Michael Esposito | Duration:2 Hours | Price: $190.00 | View Details
  • 9
  • December
  • 2020
  • Wednesday
10:00 AM PST | 01:00 PM EST

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.

Ginette Collazo Ginette Collazo | Duration:90 Minutes | Price: $150.00 | View Details
  • 9
  • December
  • 2020
  • Wednesday
10:00 AM PST | 01:00 PM EST

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.

Roger Cowan Roger Cowan | Duration:60 Minutes | Price: $150.00 | View Details
  • 15
  • December
  • 2020
  • Tuesday
10:00 AM PST | 01:00 PM EST

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.

Robert J. Russell Robert J. Russell | Duration:90 Minutes | Price: $150.00 | View Details
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