HIGH PEAKS Associates Conference Planning Services Rochester, NY


PMF 2010 Workshop on

GMP for the Microbiology Lab

May 17-18, 2010

Baltimore, MD

The purpose of this meeting is to provide a forum for the sharing of questions, answers and information on current topics in GMP for the Microbiology Laboratory. Several recent guidance documents have been issued that stress the role of the QC microbiology laboratory in the successful manufacture of finished product from both the FDA (Aseptic Processing Guidance) and USP (draft <1117> Microbiology Lab Practices). The program will range from presentations on technical and compliance-related problems to interactive case studies to round-table discussions.

This is an excellent opportunity to meet GMP training requirements for both new hires and for those responsible for training GMP to microbiology and manufacturing personnel.

Topics planned to be covered include:

  • Overview of GMPs and their history

  • Regulatory Basis of Microbiological Testing

  • FMEA and Microbiology Investigations

  • USP Perspectives

  • Lab Design

  • Technology Transfer

  • Recent Product Recalls with Microbiological basis

 

This conference will be moderated by Scott Sutton.  Scott has more than 25 years of experience in the pharmaceutical industry.  Dr. Sutton will lead a team of nationally known experts over the course of the two days, allowing all participants opportunity to address their concerns with several experts present.

Please let us know if you are interested in being informed when registration opens for this conference.

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