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: 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

Recorded on: July 20, 2017

Description: CMC program design specialist Wayland Rushing interprets stability requirements in ICH Q1 and explains how to tailor a compliance routine to fit your specific products. He discusses:

  • The requirements for ICH stability studies;
  • The requirements for analytical methods; and
  • How to interpret data generated by the stability programs.

Presentation: Download the presentation

Transcript: Download the transcript

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

Recorded on: July 18, 2017

Description: Computer system validation expert David Harrison discusses best practices and available options for validating spreadsheets. He covers:

  • Exactly what the FDA looks for and why;
  • Spreadsheet validation "gaps" the FDA is targeting;
  • How to generate spreadsheet specifications and qualification protocols; and
  • How to test spreadsheets and macros.

Presentation: Download the presentation

Transcript: Download the transcript

Speaker: David Harrison, Principal Consultant, CSV Compliance Limited

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.