Description: This 3-day course will give you a detailed look behind the Zoom meetings, conference rooms, deficiency letters, and additional information request emails of the FDA. This course will cover cybersecurity submission strategies, everything you need to know about deficiencies, and how to have success with FDA reviewers that you won’t find anywhere else.
Event Details:
- Lead Presenter - Matt Hazelett - Chief Operating Officer & Chief Quality Officer
- Date: June 10-12, 2025 (4 hours x 3 Days)
- Time: 9:00 AM to 1:00 PM (Eastern Time) Each Day
- Location: Online
Audience: This course is for medical device cybersecurity team members and regulatory affairs personnel at medical device manufacturers who are looking for insider information on the FDA cybersecurity review process.
Planned Agenda:
- Submission Strategies
- Effectively Managing Deficiencies
- Success with Reviewers