Description
<b><i>This practical, introductory</b></I> course was designed to provide
a mechanism for European auditors to understand the basic
requirements for auditing in compliance with Unites 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. Specific concerns regarding
suppliers and vendors will be presented as well. Related
topics of validation and computer systems validation are
presented as they pertain to the auditing process.<BR><BR>
A hands-on workshop will present an opportunity for
participants to apply to real life situations the information
presented as well as the methodology and techniques
learned, by designing and setting up a company cGMP audit
program.<BR><BR>
The course will consist of lectures, interactive discussions
and a hands-on workshop.<br><br>
Attend this course and its companion course. <b>Surviving an FDA Inspection -- FDA Inspections of Non-U.S. Sites</b>, ID#1880 (Offering # 0806-301) and save $400 off the combined tuition <b>(Note: Only combined regular tuition applies)
