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. 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.

Presentation: Download the presentation

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.

Presentation: Download the presentation

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.

Presentation: Download the presentation

Transcript: Download the transcript

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

Recorded on: Aug. 15, 2017

Description: Former director of the FDA Investigations Branch Ricki Chase explains FDA’s GMP guidance for combination products, focusing on the often-overlooked topic of design control. She discusses:

  • How design controls apply to combination products, including biologic/device and drug/device combinations;
  • How already available information can help speed new products to market; and
  • Using human factor studies to support combination product submissions.

Presentation: Download the presentation

Transcript: Download the transcript

Speaker: Ricki Chase, Director, Lachman Consultant Services, Inc.

Recorded on: Aug. 14, 2017

Description: FDA regulatory expert Jim O’Reilly discusses how the FDA plans to implement the variety of provisions in the 21st Century Cures Act and how those plans will affect manufacturers. He covers:

  • How the FDA Science Board's new standards can lead to much faster product development approvals;
  • How the FDA will allocate the $500 million authorized by Congress; and
  • The role of the agency’s new Office of Translational Sciences, which governs the bench-to-clinical process.

Presentation: Download the presentation

Transcript: Download the transcript

Speaker: Jim O’Reilly, Professor, University of Cincinnati College of Medicine

Recorded on: Aug. 9, 2017

Description: CDRH officials Francisco Vicenty and Daniel Walter discuss the center’s new Culture of Quality program, its goals and how it will affect inspections. They cover:

  • The disconnect between compliance and quality;
  • New metrics for evaluating device quality;
  • Accelerated approval of premarket submissions; and
  • CDRH’s new voluntary pilot program for devicemakers to help the center identify quality indicators.

Presentation: Download the presentation

Transcript: Download the transcript

Speakers: Michael Gaba, Shareholder, Polsinelli LLP; Francisco Vicenty, Program Manager for the Case for Quality, Office of Compliance, Center for Devices and Radiological Health; and Daniel Walter, Chief of the Foreign Enforcement Branch, Division of International Compliance Operations, CDRH

Recorded on: Aug. 2, 2017

Description: Regulatory lawyer Scott Cunningham interprets the new final rule on clinical trial registration, 42 CFR Part 11. He discusses:

  • The four elements of an “applicable drug clinical trial,” and how the FDA will interpret what these words really mean;
  • Who must submit clinical trial results to ClinicalTrials.gov;
  • What the FDA can do to police noncompliance and when enforcement might start; and
  • Deciphering the ClinicalTrials.gov voluntary submissions provisions.

Presentation: Download the presentation

Transcript: Download the transcript

Speaker: Scott Cunningham, Partner, Covington & Burling

Recorded on: July 27, 2017

Description: Regulatory experts Lisa Dwyer and Heather Bañuelos discuss the FDA’s three guidances covering medical product communications. Topics include:

  • What “consistent communications” means v. on-label and off-label communications;
  • How the FDA interprets the “three factor test” for consistent communications and how to apply it in practice;
  • How to evaluate consistent communications as “scientifically appropriate and statistically sound;” and
  • The real-life scope of the new safe harbor for pre-approval communications with payors.

Presentation: Download the presentation

Transcript: Download the transcript

Speakers: Lisa M. Dwyer, Partner, and Heather Bañuelos, Counsel, King & Spalding

Recorded on: July 26, 2017

Description: Microbial control expert Jim Polarine lays out the problems facing manufacturers plus state-of-the-art solutions. He discusses:

  • Proven ways to limit cleanroom contamination from incoming items;
  • Proper cleanroom design and condition;
  • Best products to control bacterial and mold spores; and
  • Current sporicide and disinfectant regulations in the U.S. and the E.U.

Presentation: Download the presentation

Transcript: Download the transcript

Speaker: Jim Polarine, Senior Technical Service Manager, STERIS Corporation