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
- 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
- Common findings of GCP inspections;
- Roles of sponsors, IRBs and individual investigators in FDA-regulated research; and
- Types of sanctions and other consequences of noncompliance.
Presentation: Download presentation
Speaker: David Rosen, Partner, Foley & Lardner
- Background and development of the Part 11 regulations;
- How the FDA’s 2010 Part 11 “Tag-Along” Inspections initiative was used to evaluate the industry’s understanding of and compliance with the regulations; and
- Common industry mistakes and misconceptions.
Presentation: Download presentation
Speaker: Gordon Richman, Vice President, Strategic Compliance Consulting and General Counsel, EduQuest
- Documenting substantiation for reduced activities to carry out an emergency plan;
- Securing alternative resources;
- FDA use of “enforcement discretion;” and
- Setting activation criteria.
Presentation: Download presentation
Speaker: John C. “Jack” Garvey, Founder, Compliance Architects
- Facilities and equipment;
- Organizational structure;
- Protocols and procedures; and
- Data and document management.
Presentation: Download presentation
Speaker: Chitra Edwin Ph.D RAC, Principal, Biotechnology Consulting Solutions