FDA Good Meeting Practices Conducting Successful FDA Meetings
Tuesday, December 12, 2023
10:00 AM PST | 01:00 PM EST
Webinar ID: 501665
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Live: One Dial-in One Attendee
Corporate Live: Any number of participants
Recorded: Access recorded version, only for one participant unlimited viewing for 6 months ( Access information will be emailed 24 hours after the completion of live webinar)
Corporate Recorded: Access recorded version, Any number of participants unlimited viewing for 6 months ( Access information will be emailed 24 hours after the completion of live webinar)
Virtually every medical device firm and pharmaceutical firm will need to meet with FDA as some time.
To be prepared for these meetings and know how to handle them can be critical to the success of your business. Communicating with FDA to determine as much a possible about their expectations regarding product submissions, clinical study design, corrective actions and other regulatory requirements is a challenge for every regulated business, but critical for drug and device firms.
FDA has formalized this meeting process and this webinar will help prepare you to handle the FDA requirements for meetings and conduct successful meetings.
Why should you Attend:
Any firm that develops and manufactures products highly regulated by FDA will need to mee with FDA employees.
FDA Meetings are dramatically different than most meetings in the business world. There must be a clean agenda, easy to understand and be limited in the information FDA is asked to provide. You must prepare detailed minutes of the meeting for FDA and your future use.
This webinar will prepare you to understand how to approach FDA for a meeting and how to ensure the meeting will accomplish what you desire.
Areas Covered in the Session:
Who Will Benefit:
- Become familiar with the types of FDA persons who conduct meetings with Industry
- Know the type of questions appropriate to ask FDA, and inappropriate to ask FDA
- Preparing an agenda for the meeting
- Know who should attend the meeting representing your firm
- How to prepare your team for the FDA meeting
- How to serve as the central spokesperson of your team at the FDA meeting
- How to judge your success after the FDA meeting
- Preparing a meeting summary for FDA
- VP's of Regulatory Affairs
- Regulatory Managers
- Consultants who assist clients with FDA Matters
Lawerence Stevenshas a unique background of FDA and Industry experience. He has over 20 years of FDA experience encompassing virtually all of the FDA field positions. He also has eighteen years of industry experience as a mid-level manager and senior executive in clinical, regulatory, and quality in the medical device industry. He has personally designed quality systems, prepared regulatory submissions (510(k), IDE and PMA) and managed 7 multi-center clinical trials for class 3 medical devices. From 1989-1993, was the Industry Representative on the FDA Circulatory Systems panel which reviewed over 30 PMA clinical studies for cardiovascular devices. He currently serves as an expert witness for cases involving FDA regulation compliance for medical devices. He regularly performs webinars regarding FDA and issues regarding clinical studies and medical devices. Finally, he is a seasoned educator/speaker with over 150 public presentations to audiences ranging from senior executives, physicians, technical personnel, other medical personnel, major media, and the general public.