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Event

cGMP Quality Principles for Pharmaceuticals, Biopharmaceuticals, Biologics and Medical Devices

March 19, 2012, March 20, 2012, March 21, 2012 iCal


Location: Dublin, Ireland

Course Description:


This course will provide the participant knowledge of current GMPs, how they are applied in the Bio/Pharmaceutical market today, and how they will be enforced in the future.

Topics included are:

  • Impact of facility and equipment design on GMP compliance
  • Risk management approach to compliance
  • Vendors
  • Commissioning, Qualification and Validation – Which one to use
  • Problem resolution
  • Part 11 in production and the laboratory
  • A comparison between 21 CFR 210/211, 600, and 810 as well as ICH guidelines will be made as they affect combination products, normal Bio/Pharmaceuticals, and Medical Devices. Current “hot” topics and examples of recent warning letters will also be discussed and evaluated.

For more information please visit: http://www.cfpie.com/showitem.aspx?productid=095&source=lsam

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