Course offering number:0903-405
Course ID:
1681
Conducting Effective Quality Audits
24-27 March 2009
Amsterdam, The Netherlands
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 role-playing 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.