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Home » Webinars

Now get all the training you need – all in one place, and all for one low price!

The FDAnews Webinar Training Pass program gives you year-round unrestricted access to any of the hundreds of webinars listed below. These training programs feature top consultants, expert speakers and FDA officials.

PLUS, subscribers get automatic access to all our new training programs for the next 12 months – that’s more than 50 new programs a year!

If you are already a Training Pass member login below and then scroll down to view the list in date order or narrow your search by keyword or category. Viewing the webinar is easy… simply identify the webinar you want to watch, click on the title and the video will begin. If you would like to view or download the presentation materials separately from the video click the "Download Presentation" link.

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Search by keyword, speaker name or just by category (drug, device or clinical) and you'll find all you need.

If you have any questions or are having any problems please give us a call on 703.538.7600 or email customer service.

Webinar Training Pass

Unified Quality, R&D and Laboratory Management with Real Time Monitoring Assure Data Integrity
55 minutes

Recorded on: Sept. 24, 2020

Description: R&D expert Pradip Banerjee discusses how to unify all quality compliance and operating processes. He covers:

  • Rapid quality transformation imperatives;
  • New operating model for Web X.0 World; and
  • Case examples.

Presentation: Download the presentation

Transcript: Download the transcript

Speaker: Pradip K. Banerjee, Chairman of the Board and Chief Executive Officer, Xybion

Quality 4.0: What's All the Buzz and Can It Really Impact Our Business?
61 minutes

Recorded on: Sept. 22, 2020

Description: Quality systems expert Tim Fischer discusses the concept of Quality 4.0 and what it entails. He covers:

  • Digital transformation initiatives;
  • Operational tools; and
  • A digital system strategic roadmap.

Presentation: Download the presentation

Transcript: Download the transcript

Speaker: Tim Fischer, Principal Partner, Great Solutions

Using Analysis of Variance — A Practical Approach to Perform Statistical Analysis Without Being a Statistician
63 minutes

Recorded on: Sept. 17, 2020

Description: Quality systems expert Dan O’Leary explains how to use analysis of variance (ANOVA) principles to examine quality data: He discusses:

  • The underlying idea that makes ANOVA work;
  • The data collection issues you should plan;
  • How to get access to ANOVA in Excel; and
  • Interpreting the result.

Presentation: Download the presentation

Transcript: Download the transcript

Speaker: Dan O’Leary, President, Ombu Enterprises

Spreadsheet Validation: Best Practices to Maintain Compliance
94 minutes

Recorded on: Sept. 17, 2020

Description: Computer system validation expert David Harrison shares best practices and available options for validating spreadsheets. He discusses:

  • FDA examples of noncompliance and regulatory concerns with respect to 21 CFR 210-211, 21 CFR Part 11 and 21 CFR Part 820;
  • How to determine spreadsheet validation gaps the FDA targets;
  • How to choose an approach for efficient and repeatable validation that fits into your traditional QA and validation processes; and
  • How to plan, manage and resource an effective project.

Presentation: Download the presentation

Transcript: Download the transcript

Speaker: David Harrison, Principal Consultant, CSV Compliance

Transforming Global Clinical Trials: Best Practices, Collaborations and the Future
67 minutes

Recorded on: Sept. 16, 2020

Description: Top officials of the Clinical Trials Transformation Initiative (CTTI) share the organization’s 10-year plan for strengthening trials’ evidence generation abilities. They discuss the five points of CTTI’s strategy:

  • Patient-centered and accessible;
  • Fully integrated with health processes;
  • Designed with a quality approach;
  • Maximally leveraging available data; and
  • Improve public health.

Presentation: Download the presentation

Transcript: Download the transcript

Speakers: Pamela Tenaerts, Executive Director, and John Alexander, Co-Chair, Clinical Trials Transformation Initiative

Modernizing Data Review with a Centralized Data Platform and Workbench
60 minutes

Recorded on: Sept. 16, 2020

Description: Data analysis experts Angela Slocum and Mitesh Devarapally discuss technology platform solutions for improving data quality and access. Takeaways include:

  • Processes for defining data review objectives in today’s data chaos environment;
  • How a centralized clinical data platform and analytics can be used to support data review objectives; and
  • Best practices for adapting data review processes to a centralized data platform and workbench.

Presentation: Download the presentation

Transcript: Download the transcript

Speakers: Angela Slocum, Senior Director of Implementation Consulting, and Mitesh R. Devarapally, Principal Medical Data Reviewer, eClinical Solutions

Implementing Remote Monitoring: Navigating Technical and Organizational Obstacles
60 minutes

Recorded on: Sept. 15, 2020

Description: Clinical trial data specialist Ken Lownie shares key insights from Agatha Life Science’s State of Remote Monitoring survey. He discusses:

  • The imperatives driving remote monitoring as a practice;
  • Understanding the technology alternatives; and
  • Calculating the costs and savings of remote monitoring.

Presentation: Download the presentation

Transcript: Download the transcript

Speaker: Ken Lownie, Head of North American Operations, Agatha Life Sciences

Expanded Access: Analysis of Latest Developments
72 minutes

Recorded on: Sept. 10, 2020

Description: A team of life sciences regulatory experts explores the expanded access terrain, provides an update on current regulatory changes and addresses possible policy solutions. Topics include:

  • The existing legal and regulatory landscape driving expanded access;
  • Recent congressional changes and how the FDA is implementing those changes;
  • The FDA’s voluntary efforts to increase use of expanded access; and
  • Policy considerations underlying the expanded access debate, such as monitoring and tracking of expanded access outcomes and adverse events.

Presentation: Download the presentation

Transcript: Download the transcript

Speakers: David Farber, Lisa Dwyer and Preeya Pinto, Partners, King & Spaulding

Implementing the IMDRF Codes
108 minutes

Recorded on: Aug. 20, 2020

Description: Device regulatory expert Dan O’Leary explains the new harmonized coding system and form for adverse event reporting. He covers:

  • The code set structures;
  • Planned changes to the FDA’s reporting form;
  • The relationship between the IMDRF codes and the current FDA codes; and
  • The EU Manufacturer’s Incident Report (MIR) and the IMDRF codes it uses.

Presentation: Download the presentation

Transcript: Download the transcript

Speaker: Dan O’Leary, President, Ombu Enterprises

Transforming Quality Management? Think Harmonizing Quality Processes First
62 minutes

Recorded on: Aug. 20, 2020

Description: A panel of quality experts discusses a practical approach to harmonizing quality processes that help accelerate technology implementation and adoption. Topics include:

  • A proven framework for harmonizing business processes;
  • Guidance on navigating complex organizations to gain support; and
  • Best practices for transforming quality management systems.

Presentation: Download the presentation

Transcript: Download the transcript

Speakers: Paola DePaso, Director, Vault Quality, Veeva Systems; Jan Paul Zonnenberg, Partner, Pharmaceutical & Life Sciences Companies, PwC; Anastasia Wengrowski, Manager, Vault Quality, Veeva Systems; and Vishaka Rajaram, Director, Pharmaceutical & Life Sciences Companies, PwC

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