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HUM-MOLGEN
-> Events
-> Courses and Workshops |
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November 26, 2013 |
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CfPA - The Center for Professional Advancement, 90 Minute Accredited Online Training
January 22, 2014 at 11:00 a.m.–12:30 p.m. (ET)
Who Should Attend
Professionals in the pharmaceutical industry that engage in the manufacture, processing, packaging or holding of drug products as well as regulatory personnel will find this course beneficial. CFR 21, Parts 211.25(a) and (b) require cGMP training on “a continuing basis for all personnel involved the manufacture of pharmaceuticals.”
This course is for employees that have been introduced to the basic cGMP concepts and need a deeper exposure to cGMP Quality Systems. Description
This course will be available On Demand: January 23, 2014
This 90-minute accredited online training course will focus on the elements, responsibilities and measurements of the pharmaceutical Quality System, the primary system of FDA's Systems Based Inspection Program. Special attention will be paid to components of the system that are often problematic and focused on by regulators. Identification of common tools that can be used by pharmaceutical personnel to solve problems and the elimination of manufacturing non-compliance will be discussed.
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Organized by:
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CfPA - The Center for Professional Advancement |
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Invited Speakers:
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William G. Marshall, President of William G. Marshall & Associates
William G. Marshall 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 five years, he has acted as a third party in several consent decrees.
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.
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Deadline for Abstracts:
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n/a
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Registration:
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Please click here for registration information.
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E-mail:
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sberg@cfpa.com
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