20 October 2016
5:30-9:00 pm
The Bridgewater Manor
Bridgewater, NJ
The Food and Drug Administration (FDA) conducts careful inspections of regulated facilities to determine a firm's compliance with regulations to the Food, Drug and Cosmetic Act. Inspections are one of many ways FDA protects the public health. Come engage with professionals from your local regulatory community to hear an interactive presentation from a representative of FDA’s New Jersey District Office on the Changing Environment of National and International Inspections.
Topics to be discussed include:
- Background
- Domestic Inspection Overview
- Changes to Domestic Inspections
- International Inspections—Who Performs Them
- International Inspection Overview
- Changes to International Inspections
This meeting is sponsored by the RAPS New York/New Jersey Chapter and is intended to promote knowledge advancement and facilitate networking among local regulatory professionals. A dinner buffet will be available to all meeting participants. Attendees who hold the RAC may claim two RAC recertification credits.
Date/Time:
Thursday, 20 October 2016
5:30–6:30 pm Registration Check-in, Networking and Dinner
6:30–8:30 pm Speaker Presentation
8:30–9:00 pm Q&A Session
Location:
Bridgewater Manor
1251 Routes 202 and 206
Bridgewater, NJ 08807
Get directions online or call +1 908 658 3000
Registration:
Prior to 14 October
RAPS members: $70 Nonmembers: $85
On or after 14 October
RAPS members: $80 Nonmembers: $95
» Registration Form (PDF) - for registration by mail or fax.
You can also register by calling +1 301 770 2920 ext. 200.
Speaker:
Helen Verdel, drug specialist, investigator, consumer safety office, FDA New Jersey District Office
Helen Verdel is a drug specialist, investigator, consumer safety officer with the FDA’s New Jersey District Office. She holds MS degrees in chemical engineering and chemistry and has QA industry experience including senior documents review, product release, handling CAPA, investigations, deviations systems and as a GMP trainer. Her experience at FDA includes training, inspection of food, cosmetic and dietary supplement facilities; inspections/investigations at pharmacy compounding and outsourcing facilities, preapproval inspections (PAI), active pharmaceutical Ingredients (API) manufacturing, finished dosage manufacturing and control testing laboratories, and training drug inspectors.
Local Contact:
Linda Bowen, RAC, FRAPS, chair, RAPS NY/NJ Chapter
RAPS Contact:
Wesley Carr, senior manager, chapter and volunteer relations, RAPS