The Role of Chromatography in Upholding Pharmaceutical Quality
Presentation/Activities
12:00 PM: Registration, Vendor Show and Posters
12:50 PM: Welcome and Introduction
Qian Zhang, NJCG Chair, BMS
Isabelle Vu Trieu, Waters Corportation
1:05 PM: Nitrosamine Risk Assessment and Control of Pharmaceutical Products
Dr. Jinjian Zheng. Merck
1:40 PM: Analytical Methodology for the Detection and Quantitation of N-Nitroso-Propanolol Using Liquid Chromatography and Tandem Mass Spectroscopy
Dr. Marian Twohig, Waters Corporation
2:10 PM: NJ-ACS Overview
Justyna Sikorska, NJ-ACS Chair,
2:20 PM: Adanced Modeling from Highly Accelerated Stability Testing (ASAP) to Determine Drug Product Shelf Life
Kenneth C. Waterman, FreeThink Technologies
2:50 PM: Break
Vendor Show and Posters
Open Bar (Sponsored by Waters Corp.)
3:50 PM: A Novel UHPLC-UV-CAD-HRMS Mutli-Detector Platform to Address Analytical Uncertainty Challenges During Extractables and Leachables Analysis
Dr. Chongming Liu
SGS Health Science
4:20 PM: Medical Device Extractables/Leachables Study: Analytical Challenges and Case Studies
Dr. Yijun Lu, Ethicon, Johnson and Johnson
4:50 PM: Vendor Show and Posters
Cocktail Hour (Sponsored by Waters Corp.)
5:50 PM: Raffle
Roger Hsu, NJCG Treasurer, Insmed
Closing Remarks
Nimisha Thakur, NJCG Secretary, Merck