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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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.
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Webinar Training Pass
Recorded on: Nov. 23, 2015
Description: Dr. Kelly Posner, chief architect of the Columbia-Suicide Severity Rating Scale (C-SSRS) discusses her research, the FDA's guidance on measuring suicidality in clinical trials and how to use the C-SSRS in multiple research settings. Topics include:
- How to use the Columbia-Suicide Severity Rating Scale (C-SSRS) to determine suicidal ideation/behavior categories;
- How a self-rated approach is part of an optimal response to guidance requirements;
- How to reduce site and sponsor burden while providing predictive capability; and
- Operational factors to be considered when capturing the important information.
Presentation: Download the presentation
Transcript: Download the transcript
Speaker: Dr. Kelly Posner, Founder, Center for Suicide Risk Assessment at Columbia University/New York State Psychiatric Institute
Recorded on: Nov. 18, 2015
Description: GMP consultant Bob Seltzer explains what issues an effective microbiology lab audit should address. Topics include:
- Sampling, sample control and chain-of-custody;
- Employee training;
- Qualifying contractors and reviewing/monitoring their performance and results; and
- Document control and record keeping.
Presentation: Download the presentation
Speaker: Bob Seltzer, President and Principal Consultant, Worldwide GMP Compliance Professional
Recorded on: Oct. 29, 2015
Description: Regulatory specialist Ronald Schoengold teaches how to build and maintain a documented system for discovering the root cause of system failures, nonconformances, product complaints and inspection findings. He discusses:
- When is a root cause analysis necessary?
- What data should you gather and whose help do you need?
- How do you check that your changes are effective?
- How will you prove it to regulators?
Presentation: Download the presentation
Speaker: Ronald Schoengold, Certified Regulatory Affairs Professional and Fellow of RAPS
Recorded on: Oct. 22, 2015
Description: Pharmaceutical patent attorney Kevin Nelson explains the FDA's draft rules for naming biosimilars and how they stack up against regulations in other countries. He covers:
- How small molecule products are named;
- The arguments and policy concerns on both sides of the naming dispute prior to the FDA's guidance; and
- Why the FDA needed to implement a naming guidance now.
Presentation: Download the presentation
Speaker: Kevin Nelson, Partner, Duane Morris LLP
Recorded on: Oct. 16, 2015
Description: Industry expert Andrew Harrison provides an overview of the draft guidance and the specific quality metrics requested. He discusses:
- How the FDA intends to use the quality metrics data;
- Who is required to comply;
- What data the FDA is proposing to be reported; and
- When the metrics/data should be reported.
Presentation: Download the presentation
Speaker: Andrew Harrison, Chief Regulatory Affairs Officer & General Counsel, Regulatory Compliance Associates, Inc.
Recorded on: Oct. 13, 2015
Description: Quality operations expert Dan O'Leary discusses how to develop a complaint management system that will pass FDA muster. Topics include:
- The difference between complaint evaluation and complaint investigation;
- The conditions that require an investigation and the associated records;
- Determining reportability as an MDR;
- Linking individual complaints to the risk management file;
- Complaint analysis to determine quality problems; and
- Linking complaint analysis results to the risk management file.
Presentation: Download the presentation
Speaker: Dan O'Leary, President, Ombu Enterprises, LLC
Recorded on: Sept. 30, 2015
Description: Alberto Grignolo, a specialist in the Japanese pharmaceutical market, explains the unique steps, priorities and expectations involved in dealing with Japanese regulators. Topics include:
- Reasons for the drug development lag between the U.S. and Japan;
- Roadmap for product development in Japan; and
- Japan's "Strategy of Sakigake" and how it aims to speed product development.
Presentation: Download the presentation
Speaker: Alberto Grignolo, Corporate Vice President, PAREXEL
Recorded on: Sept. 29, 2015
Description: Biotechnology experts Herman and Erich Bozenhardt explore commercial factors driving the industry, define future process requirements and provide a view of how change is accelerating from evolution to revolution. Topics include:
- The process technologies driving the future of the business;
- A glimpse of the minimalist, modular state that companies will evolve towards; and
- The future of compliance — a singular "bullet-proof" concept without contamination.
Presentation: Download the presentation
Speakers: Herman Bozenhardt, President, Bozenhardt Consulting Services LLC, and Erich Bozenhardt, Process Group Lead, Integrated Project Services, Inc.
Recorded on: Sept. 25, 2015
Description: Medical device engineering and compliance expert Roberta Goode explains how to avoid obstacles between your products and the European market. Topics include:
- The difference between horizontal and vertical standards;
- Which of those standards apply to each of your devices, and the last time they were updated;
- The specific kinds of objective evidence auditors will expect to see; and
- Factors that could lead to more frequent audits?
Presentation: Download the presentation
Speaker: Roberta Goode, President and CEO, Goode Compliance International
Recorded on: Sept. 22, 2015
Description: Consultant and former FDA regulatory counsel describes the FDA's expectations and qualifications and U.S. Customs' operational processes. He covers:
- What to do to minimize risk of delays, detentions and refusals;
- How to work closely with suppliers, contract manufacturers and labelers to significantly reduce hold times; and
- How to conduct a gap analysis to identify weaknesses in your existing compliance program.
Presentation: Download the presentation
Speaker: Ben England, CEO, FDAImports.com