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HUM-MOLGEN
-> Events
-> Courses and Workshops |
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October 08, 2015 |
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CfPA-The Center for Professional Advancement, Orlando, FL
February 29-March 1, 2016
Who Should Attend?
This course is designed for professionals in the Pharmaceutical, Biotechnology and related industries who design, manufacture, organize or otherwise manage drug products and/or active pharmaceutical ingredients (API). It will be especially beneficial to individuals in the following areas:
• Regulatory Affairs
• Production
• Quality Assurance
• Quality Control
• Technical Services
• Management
It should also be of interest to suppliers to these industries.
RAPS - Regulatory Affairs Professional Society
This course has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's recertification of their Regulatory Affairs Certification (RAC) upon full completion. Course Description
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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 Marshall; President, William G. Marshall and 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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The US and EU regulations will be followed by a discussion of how various large international pharmaceutical companies manage this system.
Discussions will include: what information to collect; how to use risk analysis; what metrics to use in the report; how to structure the report, when and how to issue it and proper follow up. In addition, how to convince upper management of the value of the report will be addressed.
Case studies of highly effective and poorly effective examples will be covered. This course encourages open discussions and an interactive environment.