Process Analytical Technology

                                                                          May 14, 2013

   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).

 

 

Plant Tour Joint Meeting with North Jersey (April 16)

 

 

 

 

April 9:  Efforts in sustainability –

a discussions of tools

and cooperative initiatives across industries

Abstract:

Many large retailers and brands are looking to improve the sustainability performance of their suppliers (where the majority of the life cycle impacts of the products they sell actually occur).  However, due to the lack of direct control over the methods of production, retailers and brands are using targeted questionnaires and Indexing to collect relevant data to measure performance and work to motivate improvement in the supply chain over time.  Two examples of indexing in the US (in the apparel and consumer goods retail sectors) will be touched on.

Michael will also give an overview of Life Cycle Assessment / Life Cycle Thinking, a driving tool in sustainability, and share how the Business & Institutional Furniture as well as Electronic & Electrical products industries use LCA and Environmental Product Declarations to communicate to B2B or consumers.  A connection will also be drawn from these tools to the LEED program and potential cost savings.

About the Speaker:

Michael Richardson, P.E.,LCA & Sustainable Design Sr. Project Manager

 Michael obtained his Bachelor’s and Master’s degrees in Chemical Engineering from Cornell University, and has his professional engineer’s license from the state of New Jersey.   As a sustainability consultant at SGS Michael supports clients’ sustainability efforts by helping them measure, reduce and communicate their environmental impacts, though Life Cycle Assessment (LCA) and other tools.  He also coordinates with the SGS global sustainability team, to facilitate execution internationally when expertise is needed within supply chains. Prior to joining SGS Michael worked in the environment engineering field for over 10 years: modeling contaminant generation; implementing site remediation; as well as conducting LCIs and LCAs, on products ranging from packaging to flooring.

Currently Michael is supporting clients in: the electronics Industry to prepare Environmental Product Declarations; and the cleaning product industry for environmental labeling. He has also been an active member of the Outdoor Industries No-Harm-Down working group and is co-representing SGS on the verification committee for the Sustainable Apparel Coalition.

Date

 Tuesday April 9, 2013

Agenda  
                                    Registration           6:00 PM 
                                    Dinner                    6:30 PM 
                                    Program                 7:30 PM
Location

Snuffy’s Restaurant
Mountain and Park Avenues, Scotch Plains

Price

 Members and Guests …………………..………..$30

Unemployed/Retired Section members…. $15
Students………………………………………………No Charge

Reservations

 Call Andy Soos at (908) 604-2670 or e-mail at rsvp@njaiche.org by Friday 4/5/13. 

Executive Committee Meeting

The Executive Committee meeting for April will be held on April 2 th at Paisano’s Pizza at 6:30 pm. All members are welcome.

Sponsorship

Some meetings of NJAIChE 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