Auditing for cGMP Compliance
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This course is available as a client site course. Please click here for more information.
Who Should Attend
Newly assigned auditors or those who expect to be involved
in auditing in the near future, will find the course beneficial.
Those individuals who expect their departments, groups or
functions to be audited, will also find the program of great
interest. Thus the course can be of interest to professionals
in a variety of functions such as:
• Quality Assurance
• Laboratory
• Quality Control
• Production
• Regulatory Compliance
• Engineering
• Packaging
• Purchasing
• R&D
• Vendors
Description
This practical, introductory course was designed to provide
a mechanism for European auditors to understand the basic
requirements for auditing in compliance with United States
Current Manufacturing Practice for Drugs and Finished
Pharmaceuticals and with Quality Systems regulations. The
course presents an introduction to the evolutionary process
of the regulations and provides a road map for auditors in
setting up an audit trail from beginning to end. Specific cGMP
compliance aspects in the laboratory and manufacturing
operations will be covered. Concerns regarding suppliers and
vendors will be presented as well. Related topics of validation
and computer systems validation will be presented as they
pertain to the auditing process.
A hands-on workshop will provide an opportunity for
participants to apply to real life situations the information,
methodology and techniques learned, by designing and
setting up a company cGMP audit program.
The course will consist of lectures, interactive discussions
and a hands-on workshop.
Attend this course and its companion course, Surviving an FDA Inspection–
FDA Inspections of Non-U.S. Sites, ID#1880 (Offering# 1006-302) and save $400 off the combined regular tuition. (Note: Only one discount applies)