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CfPA-The Center of Professional Advancement, Burlingame, CA
March 6-7, 2018
Who Should Attend?
This intensive 2 day course is designed for professionals in the Pharmaceutical, Biotech and other FDA regulated industries who are involved with preparing, issuing, entering data into and reviewing batch records and related reports. This includes, but is not limited to, people from
• Regulatory
• QA
• QC
• Production
• Drug and API manufacturers as well as manufacturers of excipients and
clinical Course Description
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Organized by:
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CFPA-The Center of Professional Advancement |
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Invited Speakers:
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 William Marshall, President, William G. Marshall and Associates |
William G. Marshall is President of William G. Marshall and Associates. He has over forty years of 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.
Mr. Marshall’s training continues to receive CfPA’s most highly rated reviews. He liberally uses Case Studies from Warning Letters and Consent Decrees and his 40 plus years working in manufacturing and consulting in over 25 countries. Attendees are encouraged to question , debate , and share their own problems and successes. Mr. Marshall’s style of training is to keep the course very interactive. Attendees find his enthusiasm, knowledge, and experience, wrapped in a sense of humor, stimulating as well as informative.
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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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Jmorbit@cfpa.com
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Many attendees to this course will be surprised to learn that the complicated, voluminous, difficult to understand, batch record formats that have evolved over the last 40 plus years can be simplified and that many of the items in a batch record are not required. Simplification and clarification strategies for developing or revising batch record formats, batch record review methods, the relation of the batch record to key quality systems, and typical problems involved in batch record format and review will be covered in numerous case studies.
Attendees are invited to bring their specific issues (which are frequently shared by the other attendees) to the sessions.