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CfPA - The Center for Professional Advancement, New Brunswick, NJ
November 17-18, 2014
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 supplies will find the information covered essential. Description
The Batch Record is the most crucial archived document in a Pharmaceutical Company. It plays a pivotal role in monitoring processes, initiating investigations and CAPA's, in the Annual Review, and will always be a key issue in Agency Inspections. Hopefully, there won't be a problem with marketed product; but if and when a disaster occurs, the batch record is where the investigation begins!
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.
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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, William G. Marshall & Associates
William G. Marshall is President of William G. Marshall and Associates. He 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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