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Parenteral Drug Association Connecting People, Science and Regulation ®

PDA Metro Chapter: Regulatory Inspection Readiness – Hot Topics

Apr 24 - Apr 24, 2018 |
Apr 24, 2018 |
Bridgewater Marriott | Bridgewater, NJ
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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!

Agenda

Time

Topic

Speaker

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

Catherine Oakes,
Oaks Group Global

9:20 - 10:10 am Data Integrity –Surviving a Data Integrity Audit Kelly Waldron,
Valsource
Morning Break 10:10 – 10:30 am
10:30 - 11:25 am Oversight of Contract Quality Control Laboratories

Anthony Grilli,
FOCUS 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

Richard Simone,
Bracco Diagnostics Inc.

2:15 - 3:10 pm Microbial Investigations for Sterile and Non-Sterile Products

James Agalloco,
Agalloco & Associates

Afternoon Break 3:10 – 3:40 pm
3:40 - 4:00 pm Panel Discussion/Q&A PDA Metro Chapter

Registration

Member $299
Non-member $399
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.






Register Now
https://store.pda.org/Meetings/Login.aspx?ID=4411

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