Chapter Day


The NJ Chapter of ISPE is proud to present a day of symposia on various topics including several talks comparing selected aspects of the pharmaceutical industry to other allied industries. These are Pure Water Systems by GMP Systems, and a broad look at IT Systems by Bhopti Associates.

Validation and the Latest Regulatory Trends will be covered by several industry experts. Ostrove Associates will highlight Recent Field Inspection Issues raised by the FDA. Commissioning Agents will describe the Risk Based Validation of Computer Systems. Chrai Associates will investigate the Larger Ramifications of Consent Decrees. MDI plans to offer an overview of Regulations Affecting the Medical Device Industry. New Rapid Micro Techniques are the subject of a topical talk by a representative of Pfizer, and an interesting presentation on Human Error Reduction for Complex Technologies will be presented by Talsico International.

This year’s event features an emphasis on Facility and Process Design including Clinical Materials by Aptuit, Bulk Pharmaceutical Chemicals (API) by CE&IC, Solid Dosage Processing by Parsons, and Lab Casework by Fisher Hamilton. A unique topic this year will be Career Planning Over 40 by Don Sutaria.

Another facility topic to be covered is Fire Protection System Design in Clean Pharmaceutical Facilities by CUH2A.

Other features include: New Member Orientation from 9:00-10:00 and a Career Center will be available all day.

Selected vendors will be on hand to display and discuss their related products in a tabletop venue


Time Room 1-AmbroseRoom 2-BenningtonRoom 3-Concord
8:30-9:00Registeration and Table Top Set-up
9:00-9:55Session A1
New Member Orientation
Session B1
Session C1
Vaccine Manufacturing Facility Design
Bhawani Mukherjee
9:55-10:50Session A2
Pure Water Systems Comparing Industries
Joe Manfredi
Session B2
FDA Update
Steve Ostrove
Session C2
Clinical Trial Development Process
Kristen DeVito
10:50-11:05Break and Table Tops
11:05-12:00Session A3
Fire Protection in Pharma Facilities
Paul Halamar
Session B3
Impact of Consent Decrees
Suggy Chari
Session C3
Design of API Pilot Plants
12:00-1:00Lunch Buffet & Table Tops
1:00-2:00 Session A4
Case Studies in Lab Casework Design
Rick Johnson
Session B4
Regulatory issues in Medical Device Manufacturing
Alan Schwartz
Session C4
Basics of Rapid Micro Analysis
Len Mestrandrea
2:00-2:20Break and Table Tops
2:20-3:20Session A5
Career Planning Over 40
Don Sutaria
Session B5
IT Comparison Between Industries
Rustom Bhopti
Session C5
Solid Dosage Process Technologies Carmine Stropoli
3:20-3:40Break and Table Tops
3:40-4:40Session A6
Human Error Reduction for Complex Technologies
Gail C0stello
Session B6
Risk Based Validation of Control Systems
Matt Ferrier
Session C6
Solid Dosage Finish Facilities
Steve Litman
5:00-6:00Cocktail Hour and Table Tops

Event Details:

  • Registration at the Holiday Inn begins at 8:30 am. Pre-Registration is strongly recommended, as space is limited for sessions.

  • Lunch will be served buffet style from 12:00–1:00 and refreshments will be available throughout the day.

  • Cocktails and hors d’oeuvres from 5:00 – 6:00 p.m. (Cash Bar)

  • Meeting fees are $125 for members and $150 for non-members (Non-members: if you join the ISPE the meeting fee will be discounted to the $125 member rate.) Please use the following link to join:§ion=Join+ISPE

  • ISPE STUDENT MEMBERS are admitted free of charge and student non-members meeting fee is $25(Student non-members: if an ISPE membership application is included with payment, admission will be free).

  • ISPE Members who are currently unemployed will be offered a discounted registration fee, please contact for further information.

  • Please complete the Registration below to reserve your space.
    Registration must be received NO LATER THAN June 9th, 2006

  • To register, select the appropriate category above. You will then link to a form that will enable you to choose 1st and 2nd choices for the sessions you prefer.

  • For additional information please contact Lorraine Gallo, NJ ISPE Chapter Manager at 908-325- 0345 or

  • Directions to the Holiday Inn in Somerset are available on our chapter website:

  • Cancellations received after 12:00 p.m. on June 14th, 2006 and "no shows" will still be billed.

    Name Sales End Price
    Member Ended $125
    Non-Member Ended $150
    Student - Member Ended Free
    Student - Non-member Ended $25