The Webinar Training Pass

The 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.

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.

Many of our webinars have been pre-approved by RAPS as eligible for up to 1.5 credits toward a participant’s RAC recertification. Please enter keyword RAPS below for a list of eligible on-demand webinars.

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Webinar Training Pass

Recorded on: May 17, 2017

Description: Three former colleagues of new FDA Commissioner Scott Gottleib discuss how his qualifications make him the best choice for the position. They cover:

  • How his experience and public statements indicate what his agenda as commissioner may include;
  • How he may approach staffing and funding challenges;
  • Potential increased predictability in the approval process and more in-depth guidance; and
  • A new forward-looking approach to using real-world evidence.

Presentation: Download the presentation

Transcript: Download the transcript

Speakers: Wayne Pines, President, Health Care, APCO Worldwide; Marc Scheineson, Partner, Alston & Bird LLP; Peter Pitts, Co-founder and President, Center for Medicine in the Public Interest

Recorded on: May 9, 2017

Description: International auditing expert Brian Ludovico explains the benefits of participating in the MDSAP and gives an update on the program’s status. He covers:

  • The benefits of substituting MDSAP audit reports for FDA routine inspections;
  • How to identify international regulators now participating in the MDSAP pilot process or soon to be;
  • How current participants in the program are faring; and
  • How the MDSAP affects pre- and post-market approval applications, device classification and ISO 13485 compliance.

Presentation: Download the presentation

Transcript: Download the transcript

Speaker: Brian Ludovico, Executive Director, MDSAP Regulatory Certification, NSF Health Sciences

Recorded on: May 9, 2017

Description: Quality systems expert Susan Leister discusses the recent revision of the ICH E6 Good Clinical Practice guidance and the impact changes will have on trial sponsors and sites. She covers:

  • Good documentation practices;
  • Risk-based approach to trial monitoring;
  • Internal auditing and quality management; and
  • Investigator and sponsor responsibilities.

Presentation: Download the presentation

Transcript: Download the transcript

Speaker: Susan Leister, Director of Quality Assurance, Technical Resources International

Recorded on: April 28, 2017

Description: Regulatory experts Susan Schniepp, Denyse Baker and Cylia Chen Ooi deliver an overview of the FDA’s draft guidance on quality metrics and advise you on how to use this information to improve your firm’s compliance position with the FDA. They discuss:

  • How the FDA intends to use the data collected;
  • Who is required to comply;
  • When the data must be reported; and
  • The status of PDA’s Quality Assessment Tool pilot program.

Presentation: Download the presentation

Transcript: Download the transcript

Speakers: Susan Schniepp, Fellow, Regulatory Compliance Associates Inc.; Denyse Baker, Senior Advisor, Scientific and Regulatory Affairs, PDA; and Cylia Chen Ooi, External Affairs Senior Manager, International Quality, Amgen

Recorded on: April 27, 2017

Description: Industry experts David Wolf, Dave Hadfield, Daniel Matlis and Chris Hoag discuss the benefits of using product lifecycle management to boost product quality, increase innovation, speed time to market and improve patient safety. They cover:

  • Managing risk to drive the safety and quality of products and processes;
  • Improving measurement of quality metrics; and
  • Achieving a preventive manufacturing model with an agreed risk-benefit framework.

Presentation: Download the presentation

Transcript: Download the transcript

Speakers: David Wolf, Program Director, Medical Device Strategy, PTC; Dave Hadfield, Senior Manager, Kalypso; Daniel Matlis, President, Axendia; and Chris Hoag, Director, Global RA/QA eSystems, Stryker

Recorded on: April 20, 2017

Description: Medical device regulatory expert Dan O’Leary provides a guide to rules devicemakers must understand. He discusses:

  • The risk management process in ISO 14971:2007 and the EU variant in EN ISO 14971:2012;
  • How biocompatibility fits into the risk management process;
  • How harmonized standards help implement essential requirements; and
  • The biocompatibility expectations of the EU’s new Medical Device Regulation.

Presentation: Download the presentation

Transcript: Download the transcript

Speaker: Dan O’Leary, President, Ombu Enterprises, LLC

Recorded on: April 19, 2017

Description: Attorney Jason Ma provides an overview of China’s regulatory structure and explains how to work the system to develop, manufacture and market devices in China. He discusses:

  • How to comply with arcane Chinese device rules;
  • Tips for gaining market approval, including how to find a trustworthy domestic agent to submit your applications;
  • What Chinese regulatory authorities look for under a hybrid system where marketing authorization is granted by China’s central FDA agency, but local/regional governments enforce relevant regulations; and
  • How China’s agencies function, how they relate to one another and what to prepare for in person-to-person interactions.

Presentation: Download the presentation

Transcript: Download the transcript

Speakers: Jason Ma, Attorney, Mei & Mark LLP

Recorded on: April 18, 2017

Description: Industry experts Aaron Mertens and Jim Polarine explain all the necessary components that will allow end users to be in compliance with FDA, EMA and MHR cleanroom regulations and guidances. They discuss:

  • Best practices for rotating disinfectants;
  • The critical need to control bioburden and the importance of a sound cleaning and disinfection program; and
  • The most current industry methods for applying disinfectants.

Presentation: Download the presentation

Transcript: Download the transcript

Speakers: Aaron Mertens, Technical Service Specialist, and Jim Polarine Jr., Senior Technical Service Manager, STERIS Corporation

Recorded on: April 4, 2017

Description: Regulatory submissions expert Michelle McDonough presents a step-by-step guide for developing clinical evaluation reports required by EU authorities to receive CE-marking. She discusses:

  • How to establish equivalence with existing products;
  • How to conduct a literature search; and
  • Whether countries outside the EU may adopt the same requirements.

Presentation: Download the presentation

Transcript: Download the transcript

Speaker: Michelle McDonough, Associate Director, Regulatory & Clinical Affairs, Musculoskeletal Clinical & Regulatory Advisers

Recorded on: March 30, 2017

Description: Quality management specialists Joby George and Mike Edwards discuss the impact of the FDA’s quality metrics initiative on mid-size drugmakers. They cover:

  • How and why the initiative developed;
  • Reporting by site v. reporting by product; and
  • Barriers and limitations facing mid-size companies.

Presentation: Download the presentation

Transcript: Download the transcript

Speakers: Joby George, Product Manager, Sparta Systems, and Mike Edwards, Product Manager, TrackWise