New Location - Bridgewater Marriott 700 Commons Way, Bridgewater, NJ 08807
Are you ready? Is your organization prepared for the next regulatory inspection? Your job may depend on it. The patient’s health certainly depends on it. The PDA Metro Chapter is putting together a one day seminar at a local convenient venue, full of information which can help assure a favorable outcome from your next regulatory inspection.
We have an FDA speaker who will outline current agency inspection findings, trends and focus. We also have industry leaders who will highlight hot topics to stay on top of regulatory inspections: preparedness tactics with regards to supply chain management, microbial investigations for sterile products, contract testing laboratory oversight, data integrity, and general staff preparedness and tactical considerations.
Network with colleagues and vendors during lunch and coffee breaks. Get advice from our panel during the Q&A session at the end of the day. Mark your calendar and don’t miss this valuable conference!
|7:00 - 8:15 am
||Continental Breakfast, Registration & Vendor Show
|8:15 - 8:30 am
||Welcome & Announcements
||PDA Metro Chapter
|8:30 - 9:20 am
||Supply Chain – 3rd Party Management & Oversight
Oaks Group Global
|9:20 - 10:10 am
||Data Integrity –Surviving a Data Integrity Audit
|Morning Break 10:10 – 10:30 am
|10:30 - 11:25 am
||Oversight of Contract Quality Control Laboratories
|11:25 am - 12:20 pm
||Recent FDA Inspection Domestic and Global Trends, Findings & Warning Letters
Guerlain Ulysse, CSO,
FDA NJ District Office
|Luncheon 12:20 – 1:20 pm
|1:20 - 2:15 pm
||Managing a Regulatory Inspection: An End to End Approach
Bracco Diagnostics Inc.
|2:15 - 3:10 pm
||Microbial Investigations for Sterile and Non-Sterile Products
Agalloco & Associates
|Afternoon Break 3:10 – 3:40 pm
|3:40 - 4:00 pm
||PDA Metro Chapter
Walk-ins / Register @ the door $425
Special discount for same company multiple pre-registration: $30 off each additional attendee.
Exhibitor registration available here. Contact Kimberly Sikes for exhibit and sponsorship inquiries.