3 November 2016
5:00–8:30 pm
DePuy-Synthes Headquarters
West Chester, PA
The RAPS Philadelphia Chapter invites you to spend an evening engaging with representatives from the FDA Philadephia Branch Office and others from your local regulatory community. The program will include two specific presentations as well as time to network with other attendees. Don’t miss this unique opportunity to hear directly from the FDA Philadelphia district officers about trends in enforcement and inspections, and to learn about current openings at the agency and what it takes to apply.
Scheduled presenations include:
FDA Inspection Process and Enforcement Trends
- Brief background of FDA’s authority to inspect
- Inspection “dos” (best practices) that may improve the efficiency of an FDA inspection
- A discussion of inspections from FDA’s viewpoint
- A review of current issues in drug and device inspections and how FDA is reacting to them
Interested in Working at FDA? What Do You Need to Have?
- Presentations and discussions about how to get a job with FDA
- Current openings at FDA
- Meet the FDA District Office team
A light meal will be provided and attendees may claim three RAC recertification credits.
A valid photo identification will be requires to enter the premises. Participants will not be able to gain access without a Photo ID.
Date/Time:
5:00– 6:00 pm Registration, Check-In, Networking and Light Dinner
6:00–7:30 pm Speaker Presentations and Q/A Session
7:30–8:30 pm Panel Discussion and Q/A Session
8:30 pm Closing Remarks
Location:
DePuy-Synthes Headquarters
1302 Wrights Lane East
West Chester, PA 19380
Get directions online, or call +1 610 719 5000
Registration:
Prior to 28 October
RAPS Members: $25 Nonmembers: $40
On or After 28 October
RAPS Members: $35 Nonmembers: $50
Speakers:
Karyn Campbell, director, investigations branch, Philadelphia FDA District Office
Gayle Lawson, PAI manager, Philadelphia FDA District Office
Steven Carter, director, compliance branch, Philadelphia FDA District Office
Joseph Morkunas, compliance officer, Philadelphia FDA District Office
Local Contact:
Suchitra Basu, PhD, RAC, RAPS Philadelphia Chapter Chair
RAPS Contact:
Wesley Carr, senior manager, chapter and volunteer relations