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: July 13, 2017

Description: Life sciences lawyer Roseann Termini discusses the biggest challenges facing the FDA in 2017, including:

  • Botox approvals;
  • Marijuana regulation;
  • The Opioid task force;
  • The Intended Use rule; and
  • The Right-to-Try movement.

Presentation: Download the presentation

Transcript: Download the transcript

Speaker: Roseann Termini, Editor, Life Sciences Law: Federal Regulation of Drugs, Biologics, Medical Devices, Foods and Dietary Supplements

Recorded on: July 12, 2017

Description: Statistician Steven Walfish outlines the requirements for statistical techniques and sample size and explains how they impact design control processes. He discusses:

  • Common sources of errors;
  • What types of requirements lend themselves to statistics in verification and validation; and
  • Examples of problems in which we apply statistics.

Presentation: Download the presentation

Transcript: Download the transcript

Speaker: Steven Walfish, President, Statistical Outsourcing Services

Recorded on: June 27, 2017

Description: Validation experts Rich Yeaton and Kelly Thomas share their road-tested template for using existing process validation data to satisfy regulators. They discuss:

  • How to use the template to zero in on the statistics that matter — and avoid wasting time validating things that don't matter;
  • Understanding the nuances of the new FDA final guidance; and
  • Implementing a plan that covers all the bases — process design, qualification and continued verification — in exactly the way the FDA expects.

Presentation: Download the presentation

Transcript: Download the transcript

Speakers: Rich Yeaton, President, Atlantic Technical and Validation Services, LLC; and Kelly Thomas, Vice President of Quality, Atlantic Technical and Validation Services, LLC

Recorded on: June 22, 2017

Description: Quality systems expert Dan O’Leary unravels a tangle of FDA rules and international standards that govern design control. He covers:

  • Design control from the risk management perspective and vice versa;
  • Recognizing when requirements of the one system support/complement requirements of the other; and
  • Using product safety standards to improve design control and risk management efficiency.

Presentation: Download the presentation

Transcript: Download the transcript

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

Recorded on: June 13, 2017

Description: Experts Alex Brill and Nancy Bradish Myers share insights and predictions about the current user fee reauthorization process. They discuss:

  • How the FDA affects drug competition at every level — brand-to-brand, brand-to-generic, generic-to-generic, biologic-to-biosimilar;
  • Expedited approvals and economic incentives — how the FDA promotes drug competition; and
  • Five ways Congress and the FDA can boost competition and the likelihood of each.

Presentation: Download the presentation

Transcript: Download the transcript

Speakers: Alex Brill, CEO, Matrix Global Advisors, and Nancy Bradish Myers, President, Catalyst Healthcare Consulting Inc.

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