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The Center for Professional Advancement, An Online Training Format
January 8, 2009 at 11:00 a.m. - 12:30 p.m. (EST)
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 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.
Module 1:
• Key elements in a Quality System
• What are the key Quality Systems?
• Who is responsible for these Systems?
• What are metrics?
Module 2:
• Change Control
• CAPA - Investigation - Corrective Actions
• Validation
• Audit
• Training
• Calibration
Module 3:
• Easy ways to see if the system is broken
• Simple remedies
• The pharmaceutical workers' role in maintaining the
integrity of Quality Systems
Question and Answer Session
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Organized by:
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The Center for Professional Advancement |
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Invited Speakers:
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William G. Marshall, President of William G. Marshall and Associates; Consultant to the global drug and device industry as well as to the FDA and worldwide lecturer in GMP related issues
William G. Marshall has over twenty 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. In the past 18 months, he has been involved in 10 Pre-Approval Inspections that include the first aseptic processed injectables from India, the first ever drugs from Turkey, and APIs from China, that were all approved for introduction to the US market. He has a Master's Degree in Biology from Georgetown University, Washington, DC.
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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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salbers@cfpa.com
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