
Organizer
Regulatory and Quality Solutions (R&Q)
What?
A presentation and networking event over lunch at PA Bio: Practical Considerations for Avoiding FDA Compliance Problems, and How to Manage Them If They Arise
In the session you will learn from a former FDA consumer safety officer of 20 years what it takes to proactively improve your systems to avoid problems, and proficiently manage issues if they happen to occur. First-hand experiences of how R&Q helped remediate projects will be shared, and best practice strategic and tactical solutions will be given for how to avoid those situations in the first place. We’ll also investigate emerging oversight trends, common problems, classic times in business cycle when compliance issues arise, and other specific challenges.
When?
Wednesday, May 25, 2016 from 11:30 AM to 1:00 PM (EST)
Where?
Pennsylvania Bio
650 East Swedesford Road
Suite 190
Wayne, PA 19087
Agenda
11:30 - 11:45am
Arrival and networking
11:45am - 12:30pm
Presentation and lunch (high-quality boxed lunch provided)
12:30pm - 1:00pm
Q/A and networking
Speaker
Jake O’Donnell, Senior FDA Compliance Principal, Regulatory and Quality Solutions (R&Q)