Microbiology Current Practice: Drug and Devices

February 11, 2016

CfPA-The Center for Professional Advancement, Amsterdam, The Netherlands
2-3 June 2016

Who Should Attend?
The course is designed for professionals in the medical device, biotechnology and pharmaceutical industries including:

  • Those needing a basic knowledge of microbiology as it affects their function
  • Microbiology personnel who wish to get updated on new, more reliable rapid
     testing, monitoring and identification methods and problem solving
  • Audit personnel needing more background in the microbiological aspects to
     be considered when auditing
  • Personnel with little background in microbiology, such as manufacturing,
     validation, and facilities staff that need to gain a better understanding of
     how to better deal with microbiological issues

Course Description

This course will present information on microbiological control in manufacturing, laboratory auditing and sterilization. The course will also cover ISO, EP, BP, USP, AAMI and U.S. FDA documents and guidelines. Validation of sterilization processing will be discussed and case studies will be presented. Environmental monitoring programs will be discussed in depth. Design and testing of product packages for sterility assurance will be covered via case studies. All aspects of microbiological control will be covered. Microbiological testing schemes will be presented and the key aspects of GLP/cGMP will be reviewed.

Participants are encouraged to bring samples of their own monitoring programs, procedures, flowcharts, etc. for discussions during the case studies.

Organized by:

CfPA-The Center for Professional Advancement

Invited Speakers:

William Marshall; President, William G. Marshall and Associates

William G. Marshall is President of William G. Marshall and Associates. He has nearly forty years experience in the Pharmaceutical and Medical Device Manufacturing Environment. Mr. Marshall has held Director level and Chief Operating Officer positions with large multinational pharmaceutical corporations as well as start-up ventures. He has been the Director of a major reference laboratory, and has been active in clean room design and validation. In the last 10 years, he has acted as a third party in several consent decrees, warning letters and 485 responses.

Mr. Marshall is currently a consultant to the worldwide drug and device industry as well as to the FDA. He lectures worldwide in GMP related issues including Clean Room Technology and Sterilization.

Deadline for Abstracts:

n/a

Registration:

Please click here for registration information.

E-mail:

jmorbit@cfpa.com

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