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CfPA - The Center for Professional Advancement, Burlingame, CA
February 3-4, 2014
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. Description
Regular training in the CGMPs is itself a CGMP requirement: “Training in current good manufacturing practice shall be conducted by qualified individuals on a continuing basis and with sufficient frequency to assure that employees remain familiar with CGMP requirements applicable to them.” –21 CFR 211.25(a).
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-by-system 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
February 5-6, 2014 • Burlingame, CA • Course ID #2594
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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.
Thomas J Pritchett, Ph.D., has worked with 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 and for regulators and industry professionals in the Gulf Cooperation Council (GCC). Dr. Pritchett is also an active industry consultant and the co-founder/publisher of the newsletter BioQuality (www.bioquality.biz).
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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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