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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
Structured Product Labeling
68 minutes
Description: Information management expert Antoinette Azevedo explains FDA requirements for Structured Product Labeling and offers strategies for compliance. Azevedo covers:
- 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
Medical Device Supplier Audits
79 minutes
Description: FDA insider Steven Niedelman explains the FDA’s regulations for overseeing suppliers and how to ensure outsourced operations maintain compliance. Topics include:
- 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
Change Control Forms for Medical Devices
59 minutes
Description: Noted medical device authority Barbara Immel illustrates best practices for creating effective and compliant change control forms. Immel discusses:
- 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
Description: Global legal experts Cristiana Spontoni and Maureen Bennett examine medical device approval regulations from both the U.S. and EU perspectives and discuss how they differ. Topics include:
- 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
Writing and Enforcing Effective SOPs
58 minutes
Description: Global compliance expert Annalisa Pizzarello discusses best practices in how to write SOPs and train staff to follow them. Topics include:
- 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
Analytical Method Validation Crash Course
78 minutes
Description: Validation expert Melissa Smith imparts the basics of analytical method validation and how to maintain compliance with FDA rules. Smith covers:
- 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
Clinical Trial Inspections
92 minutes
Description: Former FDA insider David Rosen explains the FDA clinical trial inspections process and offers insight into preparing for GCP audits. Topics include:
- 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
New 'Tag-Along' Part 11 Inspections
89 minutes
Description: Compliance expert Gordon Richman clarifies the FDA’s Part 11 focus on electronic systems as part of GMP inspections and offers advice for preparing systems to pass muster. Richman discusses:
- 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
Description: Jack Garvey, founder of Compliance Architects, interprets the FDA guidance “Planning for the Effects of High Absenteeism to Ensure Availability of Medically Necessary Drug Products,” discusses the agency’s intent in creating the guidance and identifies potential problem points, including:
- 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
Assuring GLP Compliance
106 minutes
Description: Biotech consultant Chitra Edwin presents the 10 key elements FDA inspectors look for in GLP audits and explains what to do to pass inspection on all counts. Areas covered include:
- 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