The Webinar Training Pass

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.

Select 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: June 8, 2017

Description: Quality advisors Mark Turner and Michelle Boucher discuss current industry trends, including:

  • The Case for Quality and how manufacturers can bridge current gaps;
  • How manufacturers should respond to rigid FDA or EU regulations and authorities; and
  • Novartis’ approach to the Case for Quality and how it applies current trends in practice.

Presentation: Download the presentation

Transcript: Download the transcript

Speakers: Mark Turner, Service Delivery Manager, Engineering, Novartis/Alcon; Michelle Boucher, Vice President for Research, Tech-Clarity

Recorded on: June 7, 2017

Description: Regulatory experts Meaghan Bailey and Caroline Rhim discuss lesser known premarket pathways created by the 21st Century Cures Act. They cover:

  • How to sort through the FDA feedback process;
  • Where and how to get regulatory information on your product classification;
  • How to focus communications with the FDA to direct your products to the best premarket pathways; and
  • The game-changers lurking within the 21st Century Cure Act and pending MDUFA goals.

Presentation: Download the presentation

Transcript: Download the transcript

Speakers: Meaghan Bailey, Executive Director, and Caroline Rhim, Managing Director, Medical Device Consulting, NSF Health Sciences

Recorded on: June 6, 2017

Description: Food law expert Steve Armstrong explains current law and regulation covering every aspect of food process labeling. He discusses:

  • Where process labeling fits among labeling claims;
  • Opportunities and challenges in transparency;
  • How to spot a risky claim;
  • How to substantiate claims that are challenged; and
  • Best practices for process label transparency.

Presentation: Download the presentation

Transcript: Download the transcript

Speaker: Steve Armstrong, independent advisor for EAS Consulting Group

Recorded on: May 31, 2017

Description: Global drug and device expert Michael Burke explains how the upcoming Brexit separation from the European Union may take shape. He discusses:

  • How Brexit may affect drug and device companies’ operations;
  • How marketing authorization will be affected in the EU and UK; and
  • Possible new locations for European Medicines Agency headquarters.

Presentation: Download the presentation

Transcript: Download the transcript

Speaker: Michael Burke, Partner, Arnall Golden Gregory

Recorded on: May 30, 2017

Description: Life Sciences experts Carmen Medina and Daniela Jansen discuss steps to take to prepare for the FDA’s quality metrics program. They cover:

  • Understanding the FDA’s quality metrics vision;
  • Developing enterprise-wide quality metrics for product lifecycle;
  • Linking to lifecycle process validation; and
  • Alternative Metrics.

Presentation: Download the presentation

Transcript: Download the transcript

Speakers: Carmen Medina, Vice President, Technical Services, PAREXEL Consulting; and Daniela Jansen, Director, Solution Marketing, Dassault Systèmes BIOVIA

Recorded on: May 23, 2017

Description: Supplier contract specialist Courtney Stevens walks you through the essentials of supply contracts. She covers:

  • How to approach a contract negotiation;
  • What every contract must include;
  • Insurance clauses and certificates of insurance; and
  • Audit provisions for further protection.

Presentation: Download the presentation

Transcript: Download the transcript

Speaker: Courtney Stevens, Senior Attorney-Risk Management and Loss Control, MedMarc Insurance Group

Recorded on: May 18, 2017

Description: Quality systems expert Dan O’Leary explains the requirements of the FDA, EU and ISO for analyzing trends in medical device complaints. He discusses:

  • Systems for analyzing, classifying and coding complaints;
  • FDA-specific coding for MDRs;
  • Coding derived from risk management files; and
  • Linking complaints, coding and risk management.

Presentation: Download the presentation

Transcript: Download the transcript

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

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