The Center for Professional Advancement, New Brunswick, NJ
October 29-November 1, 2007
Who Should Attend:
This overview course is designed for those who have recently 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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