Process Analytical Technology
JOINT MEETING: of NEW JERSEY and NORTH JERSEY SECTIONS
________________________________________________________________________
Design of
Process Analytical Systems
Abstract:
The ability to characterize input materials and monitor a process in real time enables sophisticated control strategies that maintain tight quality specifications regardless of perturbations. The presentation will discuss the engineering tools and knowledge required to design and deploy Process Analytical Technology (PAT) solutions in pharmaceutical drug substance and drug product manufacturing as an example of advanced sensing techniques which enable process control. Current PAT technologies will be discussed including the engineering theory, principles, and mathematics required to design and deploy these technologies in a pharmaceutical manufacturing environment in compliance with FDA and international regulations. There will be an overview of analyzer types and principles of operation, chemometric techniques for multivariate analysis, multivariate process models, dynamic process control, and advanced pattern recognition techniques. In addition, the presentation will cover the technical aspects of real-time data management and 21 CFR Part 11 compliance.
About the Speaker:
Daniel J. Wasser. PhD
Dr. Wasser has BS and MS degrees in Chemical Engineering and a PhD in a Biomedical Engineering and Mathematics. He began his career at Mobil Oil where he was involved in a number of projects ranging from automation of pilot-scale catalyst test units to multivariate control of refining processes. For the past fifteen years he has worked in the pharmaceutical industry and is currently Associate Director of Process Intelligence and Technology at Bristol-Myers Squibb. While at BMS, he has been involved in the design and deployment of PAT-based process monitoring and control systems for API manufacturing at both the pilot and commercial scale. In addition to his work at BMS, Dr. Wasser is an adjunct professor at Stevens Institute of Technology where he teaches a course on the design of PAT systems for pharmaceutical manufacturing.
Meeting Logistics
Date:
Tuesday May 14, 2013
Agenda
Registration 6:00 PM
Dinner 6:30 PM
Program 7:30 PM
Location
Snuffy’s Restaurant Mountain and Park Avenues, Scotch Plains
(250 Park Avenue Scotch Plains, NJ 07076, phone 908-322-7726)
Price
Members and Guests …………………..………..$25
Unemployed/Retired Section members………. $15
Students………………………………………….…No Charge
Sponsorship
Some meetings of AIChE local sections have been sponsored. If you would like to sponsor this meeting or a future meeting please let us know. Many levels of sponsorship are available.
Future Meetings
Have you heard someone speak that would be of interest to our group? Would you like to speak? We’re interested in both technical and general interest presentations. Let us know.
Professional Development Hours
PDH credits will be awarded when applicable
New Jersey Section Information:
Reservations
Call Andy Soos at (908) 604-2670 or e-mail at rsvp@njaiche.org by Friday 5/10/13.
Executive Committee Meeting
The Executive Committee meeting will be held on May 7th at Paisano’s Pizza at 6:30 pm (1511 U.S. 22, Watchung, NJ 07069 at the Watchung Square Mall).
All members are welcome.
North Jersey Section Information:
Reservations
Call Gary Prager at (973) 992-3724, or fax at (973) 992-6110, or e-mail at Prager7@comcast.net by Friday 5/10/13.
Executive Committee Meeting
The Executive Committee meeting will be held on May 8th at Jim Johnston’s at 6:00 pm
(58 Eisenhower Parkway, Roseland, NJ 07068).