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
Description: FDA regulatory expert Seth Mailhot discusses the implications of the HIPAA and HITECH acts for manufacturers of devices that store patient information. Topics include:
- Who and what is regulated under HIPAA;
- Business associate liability; and
- Research and FDA reporting exemptions.
Presentation: Download the presentation
Speaker: Seth Mailhot, Partner and Lead, FDA Regulatory Practice, Michael Best and Friedrich LLP
Description: Jay Crowley, who led the FDA team that wrote the UDI rule, talks about the most important questions and issues that remain to be resolved as the September 2014 implementation date looms. Among the challenges he discusses are:
- Switching to a standardized date format;
- How to treat stand-alone software;
- The single-use device exemption; and
- Definitions of "shipping container," "reprocessing" and "labeler."
Presentation: Download the presentation
Speaker: Jay Crowley, Vice President of the UDI practice at USDM Life Sciences
Description: Former FDA official David Lim presents a plan for inspection preparation, focusing on the top 20 problems that continually show up in 483s and warning letters and how to avoid them. Topics include:
- Resources FDA investigators use to prepare for inspections;
- Factors that determine the depth of an inspection; and
- Tips for communicating with investigators before, during and after the inspection.
Presentation: Download the presentation
Speaker: Dr. David Lim, President and CEO, RegulatoryDoctor.com
Description: Regulatory experts Timothy Ayers and Michelle Axelrod examine the FDA's new enforcement focus on television ads, trade show communications and Twitter activities, offering advice on how to respond to agency citations and develop a compliant promotions plan. Topics include:
- Common violations cited in 2013 Warning Letters;
- FDA enforcement of digital communications violations; and
- How to set standards and safeguards to ensure claims are legally defensible.
Presentation: Download the presentation
Speakers: Timothy Ayers, Principal, Life Sciences Compliance, Commercialization and Regulatory Counseling Department, Porzio, Bromberg and Newman; Michelle Axelrod, Principal, Porzio, Bromberg and Newman.
Description: In a special question-and-answer session, Steve Silverman, Director of CDRH's Office of Compliance discusses the recent reorganization of the office and what it means for devicemakers. Led by FDA veteran Steven Niedelman, the webinar addresses the responsibilities of the:
- Program Management Office;
- Division of Manufacturing and Quality;
- Division of Premarket and Labeling Compliance;
- Division of International Compliance Operations;
- Division of Bioresearch Monitoring; and
- Division of Analysis and Program Operations.
Presentation: Download the presentation
Speakers: Steven Niedelman, Lead Quality Systems and Compliance Consultant to the FDA & Life Sciences Practice Team, King & Spalding, and Steve Silverman, Director, Office of Compliance, CDRH.
Description: Supply chain analyst Hedley Rees advises on the most effective techniques for forecasting and managing clinical trial materials needs. Topics covered include:
- Mapping the end-to-end physical flow of the supply chain;
- Key information flows in the supply chain; and
- Prerequisites for successful delivery of drug to site.
Presentation: Download the presentation
Speaker: Hedley Rees, Managing Consultant, Pharma Flow
Description: Experts George Valaitis and Jean Colombel present a case study from AB SCIEX, a leading medical and laboratory equipment manufacturer, showing how they were able to reduce business risk and avoid product shipment interruptions by implementing an enterprise-level solution that integrates and verifies product compliance to RoHS, REACH and other directives at every phase of product development. Topics include:
- Today's regulatory landscape and how it affects the products devicemakers manufacture and sell in various global markets;
- An overview of the data management challenge of determining and ensuring the compliance of device products;
- The 3D Experience Platform and the Materials Compliance solution from Dassault Systèmes, and the business process and data flow that it enables; and
- Customer success stories, with a particular focus on the success at AB SCIEX.
Presentation #1: Download the presentation
Speakers: George Valaitis, RoHS Program Manager with Global Responsibilities, AB SCIEX, and Jean Colombel, Vice President of the Life Sciences Industry, Dassault Systèmes
Description: Legal expert Howard Dorfman provides an update on the status of the FDA's REMS requirements and the outlook for 2014. Dorfman discusses:
- Required REMS elements;
- Assessment time frame;
- REMS and the innovator-generic debate; and
- The revised Change Being Effected ("CBE") rule.
Presentation: Download the presentation
Speaker: Howard Dorfman, Vice President and General Counsel, Ferring Pharmaceuticals, Inc.
- Liability implications for both generic and branded manufacturers;
- Current requirements for updating labeling;
- Process for submitting labeling changes under the proposed rule; and
- Whether legal challenges will delay issuance of a final rule.
Presentation: Download the presentation
Speakers: Daniel Kracov, head of the FDA and healthcare practice at Arnold & Porter LLP, and Dan Pariser, partner and specialist in healthcare product liability, Arnold & Porter LLP
- Varying definitions of counterfeit drugs;
- U.S. legal issues and actions;
- Using intellectual property laws to combat counterfeiting; and
- How the Internet complicates the problem.
Presentation: Download the presentation
Speakers: Robert Reznick, Partner and Life Sciences Practice Co-Chair, Orrick, Herrington & Sutcliffe, and Elizabeth Howard, Partner and Intellectual Property Litigator, Orrick, Herrington & Sutcliffe