January 13,2004

Meeting at Princeton University

Dinner at 5:45 at Prospect House*

Talk at 7:30 in Room 108 Friend Engineering Center*

Contact Amanda Meyer (phone 609 258 4572)

for Dinner Reservations

Tim Flanigan

Lockwood Green

Keeping Up To Date With Current Good Manufacturing Practice

Abstract

The pharmaceutical and biotech industries are highly regulated by rules that are constantly changing. It is incumbent upon engineers who are working in this area to remain up to date with Current Good Manufacturing Practices (cGMP), and to have an good understanding of the role that engineering design plays in the successful validation of a manufacturing facility. Implementation of a well-defined Good Engineering Practices (GEP) program at the initiation of a project will greatly simplify validation procedures by addressing engineering related issues that are important to the validation effort as they emerge. A good GEP program includes areas such as GMP reviews, facility layout, material and personnel flow, equipment specifications and system boundaries. This talk will focus on recent changes to the cGMP regulations that affect engineering design and validation, and will discuss the extent to which changes can affect the manufacturing process during the design phase of the project.

Bio

Tim Flanigan is Director of Validation and Regulatory Affairs for Lockwood Greene in Somerset, New Jersey. He has over 22 years of experience in the pharmaceutical and biotech industries having spent the last 12 years in validation management responsible for quality control, quality assurance and manufacturing. Mr. Flanigan is a member of ISPE and PDA, he has authored papers on CGMP for the Journal of CGMP Compliance, presented papers for ISPE, The Association of Membrane Separation Technology of Japan and the Institute of International Research. Mr. Flanigan is an instructor for Good Manufacturing Practice in Pharmaceutical Facilities Design at the Stevens Institute of Technology. He received his BS in Public Health from the University of Massachusetts and his MBA from James Madison University.

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