ISPE NJC offers the most broadly based day of seminars we have ever offered. Dean Ford of Maverick Technologies describes a paperless plant operation in the pharmaceutical production industry. He will describe how real time data is sent from a manufacturing execution system to an ERP effort, the company CFO and other decision makers.

 Sam Herb, a veteran of the instrument and control industry has much experience at Moore Industries and Invensys.  He will enlighten us on how wireless technology is developing in this post 9/11 world. Encryption codes are getting safer and safer (harder to decode). The savings on wire and conduit that wireless operation leads to will be shown to be significant.

 We will have a thorough overview of recent developments in Biological Downstream processing by Steve Orichowskyj, of CDI Life Sciences. The challenges of purifying the higher titers and volumes of today’s bioreactors will be covered, as will the implementation of new technologies. Nick Andreopolous and Graham Wrigley will relate a case study regarding the implementation of the principles of ASTM A2500 at Pfizer,  an industry leader in implementing PAT among other cutting edge methods.

 Peter Blok of Pharma Team USA will cover Supply Chain Safety considerations, particularly as applied to drug shipment originating outside the US. RFID technology is used to track material movement, and certify products as authentic, in the age when an attack can come at any time from terrorist counterfeiters and tamperers.

 A different type of study will be offered by Cindy Lawton regarding the Ergonomics of Performing work in Isolators. Cindy is from Skan and will go over typical injuries that result from this type of work and how to address them.This years Chapter Day features some unique presentations which you won’t want to miss. Tom Moon, a veteran field construction safety professional from Torcon, will describe some of the issues OSHA brings up when they visit your construction site, and how to avoid serious financial and legal consequences through proper planning. Alex Habib of Maverick Technologies will describe how a small investment in process controls and automation can give big improvements in productivity. Return on Investment can be as short as one year for these expenditures,.illustrating how even cash strapped companies can improve their bottom line.

CANCELLED - Ramu Veerapan of Lifecycle Technologies, will speak on Understanding the changing landscape of EPC regulations and developing Track & Trace solutions . This topic is related to global supply chain integrity and anticounterfeiting, regulatory compliance, and packaging.  It is an area of growing concern for the FDA, industry and the nation’s supply of safe and efficacious drugs.  

Joe Smith of ABB will explain how to justify the use of usually high-priced real time process analyzers to document product quality. Technologies such as NIR and FTIR can conceivably eliminate many trips to the analytical laboratory and sometimes be integrated into a firm’s PAT strategy. Paul Melamud , an experienced field validation person, of Q Pharma will give a comprehensive history of our current GMP regulations, including up to the minute additions in 2009. 

Doug Petrone of Frazier Brothers will introduce us to the various types of warehouse material handling systems and storage media which are commercially available. He will cover when each is used and compare the relative merits and costs of each. Concepts of how to design a structure to optimize stage and retrieval will be touched upon also.