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: Sept. 28, 2017

Description: A panel of industry experts discuss the FDA’s view of 3D printing of medical devices. They cover:

  • Training surgeons to use 3D-printed models;
  • Applications of 3D printing across the product lifecycle;
  • Hurdles companies have faced in implementing 3D printing operations; and
  • Bio-printing models of human cells and organs for use in clinical trials.

Presentation: Download the presentation

Transcript: Download the transcript

Speakers: Thomas Marchand, CEO, BIOMODEX; Jenny Chen, CEO, 3DHEALS; Stavros Stefanis, Leader, Deloitte's Product Development Practice; Jennifer Petrosky, Director of Life Sciences Industry Marketing, Dassault Systèmes; and Daniel Matlis, President, Axendia

Recorded on: Sept. 26, 2017

Description: Quality systems specialist Dan O’Leary explains statistical techniques mandated under the FDA’s Quality System Regulation (§820.250). He discusses:

  • The difference between variables data and attributes data;
  • The concept of process variability and its common metrics;
  • Valid statistical techniques in the context of FDA’s QSR; and
  • How to apply this information to your manufacturing processes.

Presentation: Download the presentation

Transcript: Download the transcript

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

Recorded on: Sept. 19, 2017

Description: Antitrust law expert August Horvath presents real-life scenarios that illustrate what you can and cannot say in advertising. He discusses:

  • How misleading impressions occur, including why viewers misinterpret efficacy claims;
  • How to list side effects to avoid misinterpretation;
  • How to head off FDA or FTC actions against alleged unsubstantiated medical and comparison claims; and
  • Proven techniques for substantiating claims.

Presentation: Download the presentation

Transcript: Download the transcript

Speaker: August T. Horvath, Antitrust Partner, Kelley Drye

Recorded on: Sept. 14, 2017

Description: FDA experts Wayne Pines, Jill Hartzler Warner and Dan Kracov discuss FDA Commissioner Scott Gottlieb’s first months in office, including:

  • What the Gottlieb FDA is likely to continue and what will likely change;
  • What unannounced priorities the commissioner may advocate in the future; and
  • Gottlieb’s record and regulatory inclinations as well as unfolding events.

Presentation: Download the presentation

Transcript: Download the transcript

Speakers: Wayne Pines, President, Health Care APCO Worldwide; Jill Hartzler Warner, VP of Regulatory Policy, Catalyst Healthcare Consulting; and Dan Kracov, Partner, Arnold & Porter Kaye Scholer LLP

Recorded on: Sept. 13, 2017

Description: John Balzano, an expert on China’s medical device regulations, explains the current environment for devicemakers doing business in China, including:

  • General reforms of China’s administrative system;
  • Influence of reforms in other spaces; and
  • Reform of the Chinese healthcare system.

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Speaker: John Balzano, Special Counsel, Covington and Burling, LLP

Recorded on: Sept. 12, 2017

Description: Supplier accreditation experts Connie Conboy, Paul Hugo and Scott Goolsbey outline the benefits of using the MedAccred program to audit and certify suppliers. They cover:

  • Meeting FDA requirements for purchasing controls;
  • Verifying suppliers’ critical process capabilities;
  • Evaluating suppliers’ equipment, personnel and controls; and
  • How MedAccred audits differ from quality system audits.

Presentation: Download the presentation

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Speakers: Connie Conboy, Director, Strategy & Business Development, Performance Review Institute; Paul Hugo, Director, Corporate Quality, Global Technologies; and Scott Goolsbey, Supplier Controls Manager, Stryker

Recorded on: Sept. 6, 2017

Description: Health economics and outcomes specialist Jeff Trotter explains the opportunities and pitfalls of using observational studies to show evidence of product safety and efficacy and discusses the impact of the 21st Century Cures Act. He covers:

  • The critical link between strategy and operational efficiency in observational studies;
  • Setting internal and external expectations for real-world evidence; and
  • Best practices for ensuring clinical and commercial collaboration in support of observational studies and patient registries.

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Transcript: Download the transcript

Speaker: Jeff Trotter, President, Continuum Clinical

Recorded on: Aug. 31, 2017

Description: Regulatory expert Wayland Rushing explains the requirements of ICH guidance Q3D on elemental impurities in drug products. He covers:

  • Comparison of ICH Q3D vs. USP requirements;
  • Risk assessment and gathering information from suppliers;
  • Analytical strategies and techniques; and
  • Challenges associated with testing.

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Transcript: Download the transcript

Speaker: Wayland Rushing, Director of Scientific Affairs, EAG Labs

Recorded on: Aug. 24, 2017

Description: Quality systems expert Dan O’Leary analyzes the FDA’s two guidances on cybersecurity for medical devices. He covers:

  • A design control framework for cybersecurity;
  • The role of software verification and validation in cybersecurity;
  • Identifying expected cybersecurity documents in the design history file; and
  • Postmarket information, sources, and effect on cybersecurity.

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

Recorded on: Aug. 22, 2017

Description: Biologics experts Suzanne Sensabaugh and Nitisha Pyndia explain the FDA’s view of interchangeability in biosimilars. They discuss:

  • The most challenging areas of product development — including technical issues of similarity in purity and potency — and how to comply;
  • How the FDA evaluates immunogenicity, a key factor entailing communication and cooperation with scientific colleagues;
  • The chemistry of structural features; and
  • Understanding the differences between interchangeability and biosimilarity.

Presentation: Download the presentation

Transcript: Download the transcript

Speakers: Suzanne M. Sensabaugh, President and Principal Consultant, and Nitisha Pyndiah, Consultant, HartmannWillner