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.
Also available: Take advantage of our multi-user and site licenses of the Webinar Training Pass, so you’ll have the most-informed workforce! Contact Russ Titsch, Business Development Director at russ.titsch@wcgclinical.com or +1 703.538.7651 to receive a custom quote.
Search by keyword, speaker name or just by category (drug, device or clinical) and you'll find all you need.
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Webinar Training Pass
- Reporting adverse events;
- Patent ownership;
- Labeling; and
- Product liability.
Presentation: Download presentation
Speaker: Alan Minsk, Partner and Chair of the Food & Drug Practice Team, Arnall Golden Gregory LLP
- What is – and isn’t – a signal;
- Methods for identifying signals;
- Data sources; and
- ypes of questions that can be answered by using data mining methods.
Presentation: Download presentation
Speaker: Elizabeth Garrard PharmD. R.Ph., Chief Safety Officer, Drug Safety Alliance Inc.
- Using risk management tools to determine which suppliers to audit;
- Audit frequencies and schedules;
- Qualifying suppliers for reduced testing; and
- Tailgate sampling.
Presentation: Download presentation
Speaker: Steven Sharf, President, GMP Concepts
- Creating a master audit schedule;
- Establishing the scope of the audit;
- Training personnel for inspections; and
- Auditor qualifications and responsibilities.
Presentation: Download presentation
Speaker: John Gagliardi, President, MidWest Process Innovation LLC
Considerations for registry design;
- Finding the most suitable data source/approach;
- Using chart review studies to capture data retrospectively; and
- Building effective registry teams.
Presentation: Download presentation
Speaker: Peggy Schrammel, VP-Registries and Post Approval Development, United BioSource
- How EHRs can cut the time and cost of communicating REMS elements;
- Incentives the law provides for hospitals and providers, and penalties for those that don’t make the switch by 2015;
- Information flow from drugmakers to providers through EHRs; and
- Potential opportunities and liabilities.
Presentation: Download presentation
Speaker: Edward Fotsch M.D., CEO, PDR Network LLC
- Differences in requirements for IRBs, sponsors and investigators;
- Clarification of terminology in FDA regulations prior to 2010; and
- Product liability risks.
Presentation: Download presentation
Handout – Drug Withdrawls In The US
Speakers: Joan Antokol, Managing Partner, Park Legal LLC and Dr. John (Jack) McLane, COO, Clinquest Inc.
- Selecting suppliers with compatible standards and principles;
- Providing information on suppliers to the FDA;
- Contracts and Service Level Agreements; and
- Continuing improvement of a supplier management system.
Presentation: Download presentation
Speaker: Martin Browning, Founder and President, EduQuest
- How to accommodate the complexity of the warehousing and logistics process in a quality agreement;
- Special considerations, such as cold chain control and handling controlled substances;
- How to define metrics and monitoring methods.
Presentation: Download presentation
Speaker: Jim Darnell, Managing Consultant, Tunnell Consulting
- How the Bayesian method differs from the more commonly used Frequentist approach;
- Benefits and costs of using the Bayesian method;
- Basic probability laws; and
- Examples of the method’s practical application.
Presentation: Download presentation
Speaker: Dr. Robert Thiel, Founder and CEO, THIEL Statistical Consultants