cGMP/QSR OVERVIEW - PART I This
course provides clear understanding of the requirements of current Good Manufacturing Practices (cGMP) and Quality System
Regulation (QSR), and how it is currently interpreted by the Food and Drug Administration (FDA).
This
course is designed for Manufacturing, QA/QC, Engineering, Materials Management, and other personnel as desired. Training to
be covered by industry leaders.
Emphasis on the following:
Overview and differences between cGMP and QSR
Quality Management Principles
Documentation and Records
Materials Management
Production and Process Changes
Contamination Control
Reprocessing
Sampling