Archive for December, 2007

GAMP® 5 to be launched by ISPE at February conference

Thursday, December 27th, 2007

ISPE will present the global launch of GAMP® 5: A Risk-Based Approach to Compliant GXP Computerized Systems, its latest industry-impacting technical publication, at its Conference on Manufacturing Excellence, 25-28 February 2008 in Tampa, Florida, USA.

“It’s a major revision, and it is aimed at enabling innovation and pragmatic, cost-effective compliance,” said Sion Wyn, editor of the Guide. In this major upgrade, GAMP 5 addresses the entire lifecycle of an automated system and its applicability to a wide range of information systems, lab equipment, integrated manufacturing systems, and IT infrastructures. A complimentary copy of GAMP 5 will be provided to conference delegates attending the session titled” GAMP 5: Enabling Innovation and Technological Advance. The Conference focuses on manufacturing excellence with eight educational seminars, and for the first time, two training courses. ISPE is a global not-for-profit association of 25,000 pharmaceutical manufacturing professionals.

ISPE Names Award Winners

Thursday, December 6th, 2007

More than 2,700 professionals attended the ISPE 2007 Annual Meeting at Caesars Palace in

Las Vegas. Among the excitement were the announcements of our Member Award Winners.The winners are:

  • Bruce R. Moon, who received the Richard B. Purdy Distinguished Achievement Award. Bruce works for PharmaDirection Pty Ltd. in Hornsby, NSW Australia.
  • David W. Selby, PhD received the Professional Achievement Award. David is the Managing Director of Selby Hope International Ltd., in N Yorks, United Kingdom.
  • Russ Somma, PhD won the Max Seales Yonker Member of the Year. Russ is the President of SommaTech, LLC, in Sparta, New Jersey.
  • Ronald Menendez and Darrell Tanner won the Roger F. Sherwood Article of the Year Award for their article titled, “Unified Manufacturing Control System Architecture for Pharmaceutical and Biotech Manufacturing,” published in the March/April issue of Pharmaceutical Engineering. Ronald Menendez is a Sr. Automation Engineer, Genentech, in Vacaville, California. Darrell Tanner works for Honeywell in

    Duluth, Georgia.
  • Student Poster Presentation Awards went to: Graduate Category: John Eisenbrey, Drexel University, Delaware Valley Chapter; Undergraduate Category: Katherine (Kate) Freed, Stevens Institute of Technology, New Jersey Chapter.
  • Pfizer was named Company of the Year and recognized for outstanding support provided by a company as reflected by significant active participation in the Society’s committees, councils, task teams, Communities of Practices, programs, and activities.
  • Singapore and Turkey are Affiliates of the Year, recognized for outstanding work as reflected by membership development and services, management, industry and Society support, and innovation.
  • Polytechnic University of Puerto Rico is the 2007 Student Chapter of the Year Award Winner.


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