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CfPA-The Center for Professional Advancement, Burlingame, CA
October 6-7, 2015
Who Should Attend?
This regularly-updated course is designed to provide the industry standard of yearly training for all persons who work, or have been hired to work, in a Current Good Manufacturing Practice (CGMP) regulated environment within a Biopharmaceutical, Vaccine, or other Biologics company.
This includes, but is not limited to
• Compliance, Development
• Manufacturing and Production
• Quality Assurance
• Quality Control
• Regulatory Affairs
• Validation
The course will also be of benefit to supervisors in GMP areas and to mid-level and senior managers whose span of responsibility includes functional areas which require CGMP compliance. 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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| Thomas J Pritchett, Ph.D., Consultant |
Thomas J Pritchett, has worked with the US, European, and Canadian pharmaceutical, biopharmaceutical, and biologics industries for more than 25 years, during which he has gained considerable experience in regulatory and technical aspects of Quality Assurance, Quality Control and CGMP Compliance for both investigational and marketed products. He is also an experienced teacher, and has been directing courses for the Center for Professional Advancement since 1995. In addition, Dr. Pritchett has provided training sessions for the US FDA, for regulators and industry professionals in the Gulf Cooperation Council (GCC) and at the National Institutes of Health. Dr. Pritchett is also an active industry consultant and the co-founder/publisher of the newsletter BioQuality (www.bioquality.biz). He sits on the editorial advisory board of BioProcess International.
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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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This course is designed to speedily enhance your knowledge of essential Good Manufacturing Practice and related regulatory compliance skills using as examples the GMPs of the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA). Understanding these regulations is the best preparation for dealing with the regulatory frameworks of most other countries’ authorities.
The essential requirements are discussed system-bysystem and--going beyond the regulatory language--current expectations are discussed and dissected with emphasis on aseptic processing, maintenance of sterility, dealing with product complexity, and other issues and concerns of special importance to biological products. The course focus is on understanding the principles underlying regulations, requirements, and expectations. This course follows a unique 5-step format designed to achieve maximum understanding in minimal time.
Maximize Your Learning!
Attend this course and its Companion Course:
Stability Testing for Protein Drug Products & Substances
October 8-9, 2015 • Burlingame, CA • Course ID #2594