Conducting Effective Quality Audits
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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
- R&D
- Regulatory
- Materials Management
- Packaging
- Laboratory
- Production
- Toxicology
- Clinical Research
- 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.
Other Courses of Interest
Auditing for cGMP Compliance
Jun 18 2009, Amsterdam, The Netherlands
Applied cGMPs for Pharmaceutical and Allied Industries
Mar 23 2009, Burlingame, CA
Documentation Management and Control
Feb 23 2009, New Brunswick, NJ
Documentation Management and Control
Mar 30 2009, Amsterdam, The Netherlands
Pharmaceutical Production and QA/QC Records and Reports
Surviving an FDA Inspection -- FDA Inspections of Non-U.S. Sites
Jun 16 2009, Amsterdam, The Netherlands
Related Industries