Live Webinars Recorded Webinars

17
August
2020
Monday

10:00 AM PDT | 01:00 PM EDT

Sample Size Determination for Design Validation Activities

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

Steven Wachs | Duration:90 Minutes | Price: $150.00 View Details

17
August
2020
Monday

07:30 AM PDT | 10:30 AM EDT

GxP/GMP Requirements and its Consequences for Documentation and Information Technology Systems

Documentation is a critical tool for ensuring GxP/GMP compliance.

Eleonora Babayants | Duration:90 Minutes | Price: $150.00 View Details

18
August
2020
Tuesday

10:00 AM PDT | 01:00 PM EDT

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.

Edwin Waldbusser | Duration:60 Minutes | Price: $150.00 View Details

18
August
2020
Tuesday

09:00 AM PDT | 12:00 PM EDT

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 | Duration:3 Hours | Price: $290.00 View Details

19
August
2020
Wednesday

10:00 AM PDT | 01:00 PM EDT

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 | Duration:90 Minutes | Price: $150.00 View Details

19
August
2020
Wednesday

10:00 AM PDT | 01:00 PM EDT

Applying Internal Control Techniques to Excel Spreadsheets

Excel expert David Ringstrom, CPA, shows you how to implement internal control features within your Excel spreadsheets in this enlightening presentation.

David Ringstrom | Duration:60 Minutes | Price: $150.00 View Details

20
August
2020
Thursday

10:00 AM PDT | 01:00 PM EDT

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 | Duration:60 Minutes | Price: $150.00 View Details

20
August
2020
Thursday

10:00 AM PDT | 01:00 PM EDT

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 | Duration:90 Minutes | Price: $150.00 View Details

25
August
2020
Tuesday

10:00 AM PDT | 01:00 PM EDT

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.

Dennis Taylor | Duration:60 Minutes | Price: $150.00 View Details

25
August
2020
Tuesday

10:00 AM PDT | 01:00 PM EDT

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.

Danielle DeLucy | Duration:60 Minutes | Price: $150.00 View Details

26
August
2020
Wednesday

10:00 AM PDT | 01:00 PM EDT

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?

Jeff Kasoff | Duration:60 Minutes | Price: $150.00 View Details

26
August
2020
Wednesday

10:00 AM PDT | 01:00 PM EDT

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 | Duration:90 Minutes | Price: $150.00 View Details

26
August
2020
Wednesday

10:00 AM PDT | 01:00 PM EDT

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.

John E Lincoln | Duration:90 Minutes | Price: $150.00 View Details

27
August
2020
Thursday

10:00 AM PDT | 01:00 PM EDT

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.

Edwin Waldbusser | Duration:60 Minutes | Price: $150.00 View Details

28
August
2020
Friday

10:00 AM PDT | 01:00 PM EDT

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.

Michael Esposito | Duration:90 Minutes | Price: $150.00 View Details

28
August
2020
Friday

10:00 AM PDT | 01:00 PM EDT

Master Excel: What-If Analysis Tools

Excel expert David H. Ringstrom, CPA, draws your attention to the What-If Analysis tools available within Excel’s Data menu in this informative presentation.

David Ringstrom | Duration:60 Minutes | Price: $150.00 View Details

1
September
2020
Tuesday

09:00 AM PDT | 12:00 PM EDT

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 | Duration:3 Hours | Price: $290.00 View Details

1
September
2020
Tuesday

10:00 AM PDT | 01:00 PM EDT

Excel's Data Management Tools

Microsoft says that up to 70% of users surveyed use Excel to maintain a database or large lists. To be truly proficient in Excel, you must be familiar with these tools to manage data efficiently. It's all the more important as data collection has become more automated and you're getting swamped with tons of data.

Dennis Taylor | Duration:60 Minutes | Price: $150.00 View Details

2
September
2020
Wednesday

10:00 AM PDT | 01:00 PM EDT

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 | Duration:90 Minutes | Price: $150.00 View Details

2
September
2020
Wednesday

10:00 AM PDT | 01:00 PM EDT

Writing Excellent SOPs

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

Susanne Manz | Duration:90 Minutes | Price: $150.00 View Details

3
September
2020
Thursday

10:00 AM PDT | 01:00 PM EDT

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 | Duration:60 Minutes | Price: $150.00 View Details

8
September
2020
Tuesday

10:00 AM PDT | 01:00 PM EDT

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 | Duration:90 Minutes | Price: $150.00 View Details

9
September
2020
Wednesday

10:00 AM PDT | 01:00 PM EDT

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.

Jeff Kasoff | Duration:60 Minutes | Price: $150.00 View Details

9
September
2020
Wednesday

10:00 AM PDT | 01:00 PM EDT

Shortcuts for Managing Excel Lists and Databases

This webinar will teach you how to take huge amounts of data and produce meaningful information from that data.

Tom Fragale | Duration:60 Minutes | Price: $150.00 View Details

10
September
2020
Thursday

10:00 AM PDT | 01:00 PM EDT

Bad Standard Operating Procedures (SOPs) = Bad Training: Garbage In, Garbage Out

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 | Duration:90 Minutes | Price: $150.00 View Details

10
September
2020
Thursday

10:00 AM PDT | 01:00 PM EDT

Essentials of Validation – IQ, OQ, PQ

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

Susanne Manz | Duration:90 Minutes | Price: $150.00 View Details

15
September
2020
Tuesday

10:00 AM PDT | 01:00 PM EDT

Filtering Techniques for Microsoft Excel Data

This webinar will teach you how to take huge amounts of data and produce meaningful information from that data.

Tom Fragale | Duration:60 Minutes | Price: $150.00 View Details

15
September
2020
Tuesday

10:00 AM PDT | 01:00 PM EDT

Mastering Excel: How to Create ad hoc and Date Based Groupings within a PivotTable

PivotTable capabilities are enormous; among its many tools and features

Dennis Taylor | Duration:60 Minutes | Price: $150.00 View Details

16
September
2020
Wednesday

10:00 AM PDT | 01:00 PM EDT

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.

Edwin Waldbusser | Duration:60 Minutes | Price: $150.00 View Details

16
September
2020
Wednesday

10:00 AM PDT | 01:00 PM EDT

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 | Duration:90 Minutes | Price: $150.00 View Details

16
September
2020
Wednesday

10:00 AM PDT | 01:00 PM EDT

Outlook Best Practices: Get Organized with Microsoft Outlook

This 60 minute Get Organized with Outlook session will encourage and enlightened Outlook users on how to use Microsoft Outlook to more confidently and efficiently organize their information and commitments.

Tom Fragale | Duration:60 Minutes | Price: $150.00 View Details

18
September
2020
Friday

10:00 AM PDT | 01:00 PM EDT

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.

Susanne Manz | Duration:90 Minutes | Price: $150.00 View Details

18
September
2020
Friday

10:00 AM PDT | 01:00 PM EDT

Excel Update: Logic Functions: IF, AND, OR, and More

If you're looking for ways to improve the integrity of your decision-making formulas other than relying on Excel's IF function, you'll find this presentation quite helpful.

David Ringstrom | Duration:60 Minutes | Price: $150.00 View Details

21
September
2020
Monday

10:00 AM PDT | 01:00 PM EDT

Using Learning Management Systems (LMS) to Develop Pharma Training: Rewards & Challenges

Learning Management Systems (LMSs) are important tools for assuring and demonstrating that Pharma employees maintain their training, and their GMP compliance, up to date.

Michael Esposito | Duration:90 Minutes | Price: $150.00 View Details

22
September
2020
Tuesday

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 | Duration:60 Minutes | Price: $150.00 View Details

23
September
2020
Wednesday

10:00 AM PDT | 01:00 PM EDT

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.

Jeff Kasoff | Duration:60 Minutes | Price: $150.00 View Details

29
September
2020
Tuesday

10:00 AM PDT | 01:00 PM EDT

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.

Edwin Waldbusser | Duration:60 Minutes | Price: $150.00 View Details

29
September
2020
Tuesday

10:00 AM PDT | 01:00 PM EDT

Master Excel - Pivot Table Advanced Proficiency

In this presentation, Excel expert David Ringstrom, CPA, digs deeper into pivot tables to show you step-by-step how to manipulate your pivot table data faster and more efficiently.

David Ringstrom | Duration:60 Minutes | Price: $150.00 View Details

30
September
2020
Wednesday

10:00 AM PDT | 01:00 PM EDT

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 | Duration:90 Minutes | Price: $150.00 View Details

5
October
2020
Monday

09:00 AM PDT | 12:00 PM EDT

3-Hour Virtual Seminar: 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 | Duration:3 Hours | Price: $290.00 View Details

19
October
2020
Monday

10:00 AM PDT | 01:00 PM EDT

Mastering Excel: Optimizing Financial Statements

This webcast presented by Excel expert David H. Ringstrom, CPA, teaches you how to create dynamic financial statements for any month of the year on a single worksheet.

David Ringstrom | Duration:60 Minutes | Price: $150.00 View Details

21
October
2020
Wednesday

10:00 AM PDT | 01:00 PM EDT

Excel Top 10 Functions and How to Use Them - Turn Your Business Data Into Insightful Information

In the business world, or within your organization, you probably experience large amounts of data.

Tom Fragale | Duration:60 Minutes | Price: $150.00 View Details

5
November
2020
Thursday

10:00 AM PDT | 01:00 PM EDT

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 | Duration:60 Minutes | Price: $150.00 View Details

18
November
2020
Wednesday

10:00 AM PDT | 01:00 PM EDT

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 | Duration:60 Minutes | Price: $150.00 View Details

3-Hour Virtual Seminar on Design Controls for Medical Devices

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Project Management for Non-Project Managers

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

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

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

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

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

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

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

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

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

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

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

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

Valid Statistical Rationales for Sample Sizes

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

Fishbone Diagramming

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

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

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

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

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

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

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

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

Valid Statistical Rationales for Sample Sizes

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

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

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

Secrets to Writing Effective SOPs for Medical Device QMS

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

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

Fishbone Diagramming

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

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

Quality is not an Organization

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

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

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

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

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

Fishbone Diagramming

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

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

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

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

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

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

Excel Formulas and Functions

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