8:10 How to Conduct Yourself During an Agency Inspection
Mr. Jim Carignan, RQAP-GLP, Chiron Corp.
What happens when you hear to the feared words, “The agency is here to conduct a formal inspection?” What should you do? What should you say? What do you give them? What can they take? Those are questions that haunt most of us who work in a regulated environment. Prior experience is no guarantee. Many people who have experienced an inspection are still not sure of what is truly appropriate to say or do. For the inspection novice, this session will provide an overview of what typically happens during an inspection. For the more experienced, it will provide suggestions on how you, your management and staff should conduct yourselves during, what for most of us, is an extremely tense situation. It won't turn a sow's ear into a silk purse, but properly applied, the suggestions will maximize your efforts and increase the likelihood of a successful inspection result.

8:45 FDA 483 Warning Letters 
Mr. Patrick DeVillier, Director, Compliance, A.P. Pharma, Inc.
In coming to understand FDA 483s and the potential for subseqeunt warning letters we will begin with an overview of FDA inspections and related regulations. Our discussions will include preparing for an inspection and the hosting of an FDA inspection. We will cover and assess the nature of the most common types of observations documented by field inspectors on Form FDA 483. Having received a 483, we will discuss a pragmatic approach to providing effective responses in a timely manner. 

9:20 CAPA Compliant Root Cause Investigation and Documentation
Mr. John Ager, Consultant, Kepner Tregoe Inc.
Learn to conduct robust root cause analyses on unexpected deviations using lab, manufacturing and quality data to clearly document investigations to prevent FDA 483s, inspection findings, and warning letters. This presentation will present a systematic four step process to find root cause. First, describe the problem with a clear, complete problem statement and specification. Second, identify possible causes using both knowledge and experience as well as distinctions and changes. Third, evaluate possible causes by testing them against the problem specification to determine the most probable cause. Finally, confirm the true cause by verifying assumptions, observing, experimenting, fixing, and monitoring.

9:55 Networking Coffee Break, Poster Viewing

12:00 Lunch on Your Own (Luncheon Workshop Sponsorship Available)

1:15 Chairperson’s Remarks