" ISPE NJ 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-Ambrose||Room 2-Bennington||Room 3-Concord|
|8:30-9:00||Registeration and Table Top Set-up|
New Member Orientation
|Session B1 |
|Session C1 |
Vaccine Manufacturing Facility Design
Pure Water Systems Comparing Industries
|Session B2 |
|Session C2 |
Clinical Trial Development Process
|10:50-11:05||Break and Table Tops|
Fire Protection in Pharma Facilities
|Session B3 |
Impact of Consent Decrees
|Session C3 |
Design of API Pilot Plants
|12:00-1:00||Lunch Buffet & Table Tops|
Case Studies in Lab Casework Design
|Session B4 |
Regulatory issues in Medical Device Manufacturing
|Session C4 |
Basics of Rapid Micro Analysis
|2:00-2:20||Break and Table Tops|
Career Planning Over 40
|Session B5 |
IT Comparison Between Industries
|Session C5 |
Solid Dosage Process Technologies Carmine Stropoli
|3:20-3:40||Break and Table Tops|
Human Error Reduction for Complex Technologies
|Session B6 |
Risk Based Validation of Control Systems
|Session C6 |
Solid Dosage Finish Facilities
|5:00-6:00||Cocktail Hour and Table Tops|
Cancellations received after 12:00 p.m. on June 14th, 2006 and "no shows" will still be billed.
|Student - Member||Ended||Free|
|Student - Non-member||Ended||$25|
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