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The Center for Professional Advancement, New Brunswick, NJ
May 5-8, 2008
Who Should Attend
This overview course is designed for those who haverecently been involved or expect to be involved in external or internal audits.
The program will benefit individuals in the pharmaceutical and related industries such as cosmetics, food, medical devices, diagnostics, biotechnology as well as vendors, suppliers and contract organizations. The course can be of interest to professionals in a variety of functions such as:- QA/QC
- Laboratory
- R&D
- Production
- Regulatory
- Toxicology
- Materials Management
- Clinical Research
- Packaging
- Purchasing
Description
Government regulations have both explicit and implicit requirements for an internal audit function in the pharmaceutical and related industries. Auditing is a powerful management tool in establishing how effectively a company controls the quality of its products and ensures compliance. The course will deal primarily with auditing techniques which are applicable to any industry or function. Specific examples will cover auditing of certain aspects of operations for compliance with GMP, GCP and GLP. An FDA viewpoint on auditing/inspecting will be presented. The course will consist of lectures, discussions, exercises, workshops and a roleplaying session involving a simulated compliance audit.
The course is not designed for in-depth presentation of regulatory issues, which are covered by other courses offered by CfPA.
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Organized by:
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The Center for Professional Advancement |
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Invited Speakers:
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Renée B. Galkin; Quality Management Consultant
Renée B. Galkin is a quality management consultant whose expertise includes FDA regulatory compliance, quality audits, cGMP training, documentation systems management, SOP standardization and organizational development. Prior to starting her own consulting business, Ms. Galkin held managerial positions with two major companies. She was part of Corporate Quality Assurance at Ayerst Laboratories, a division of American Home Products Corporation (now Wyeth), where she managed quality audit programs in preclinical, clinical and manufacturing areas. Previously, Ms. Galkin was associated with Science Management Corporation, a multinational consulting firm, where she had both domestic and overseas assignments.
Ms. Galkin holds an MBA in Business Management from New York University, an M.A. in Education from Brown University and a Bachelor of Science in Biology from Northeastern University. She is a member of the American Society for Quality, the Parenteral Drug Association and the International Society for Pharmaceutical Engineering (ISPE).
Ms. Galkin is a frequent speaker at professional conferences and directs other technical courses offered by The Center for Professional Advancement.
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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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info@cfpa.com
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