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The Center for Professional Advancement, An Online Training Format
December 11, 2008 at 11:00 a.m. - 12:30 p.m. (EST)
Who Should Attend
This course will be beneficial to professionals in the pharmaceutical industry especially:
• Employees who need basic cGMP training
• New Hires or Transfers from non cGMP areas
• Employees who have demonstrated a need for retraining
Description
This 90-minute accredited training course introduces the employee to the cGMP environment. The attendee will gain understanding of the FDA, the Code of Federal Regulations, the reason for the unique laws governing pharmaceutical manufacturing and its role in the pharmaceutical arena.
Module 1:
• The need for the FDA and the cGMP's in our industry
• FDA enforcement
• The “Act”
• Introduction to 21 CFR, Parts 210 and 211
• Case study from the early cGMP history
Module 2:
• CFR 21, Part 210 Definitions
• The index to Part 211
• A brief overview of each section of 211 with examples of
how they relate to job performance
• A case study of how a company uses cGMP's to gain
instructions for improving their performance
Module 3:
• The 7 key areas that are necessary for compliance to the
cGMPs
– Follow good documentation
– Keep it clean
– Follow procedures
– Don't make any unauthorized changes to anything
– Avoid mix-ups
– When in doubt, ask
– The data, record and logs we create doing our job are
critical; The most critical is the batch record
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 is President of William G. Marshall and Associates; Consultant to the worldwide 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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