The FDAnews Webinar Training Pass program offers year-round, unrestricted access to any of the hundreds of webinars listed below. These training programs feature thought leadership and best practices from top consultants, expert speakers and current and former FDA officials. New webinars are offered every month, along with access to the Webinar Training Pass archive.
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Webinar Training Pass
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
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