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.
BUY NOW Single-User 1-Year Unlimited Access $1,362
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.
If you have any questions or are having any problems please give us a call on 703.538.7600 or email customer service.
Webinar Training Pass
- 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
- Data sharing using SPL;
- Information workflow; and
- echnology requirements and timeline for establishing an SPL system.
Presentation: Download presentation
Speaker: Antoinette Azevedo, Founder, e-SubmissionsSolutions.com
- Ways to evaluate, audit and select potential contractors;
- What to include in a supplier contract;
- Risk-based auditing of current suppliers; and
- Corrective action planning.
Presentation: Download presentation
Speaker: Steven Niedelman, Senior Consultant, Crowell & Moring LLP
- Using electronic change control forms;
- Types of changes requiring FDA approval;
- Real-Time PMA supplements; and
- How the FDA inspects devicemakers design and change control systems.
Presentation: Download presentation
Speaker: Barbara Immel, President, Immel Resources LLC
- Device classification;
- Clinical investigation;
- Basic regulatory references; and
- Definitions and interpretation of differences.
Presentation: Download presentation
Speakers: Cristiana Spontoni, European Partner, Squire, Sanders & Dempsey LLP and Maureen Bennett, Partner, Squire, Sanders & Dempsey LLP
- Developing a documentation strategy;
- Identifying roles and responsibilities; and
- Reviewing and revising SOPs throughout their lifecycle.
Presentation: Download presentation
Speaker: Annalisa Pizzarello, Head of Global Compliance, Amgen
- Elements and types of method validation;
- When and how to validate methods;
- Setting specification criteria; and
- International Conference on Harmonization quality guidelines.
Presentation: Download presentation
Speaker: Melissa Smith, Co-chair, PDA Task Force for Method Development and Qualification