Quality Systems Track

Print this page         

This highly-interactive, pre-recorded online course reviews the quality system and its importance within the USFDA Systems Inspection Approach, as well as the roles and responsibility of the quality control unit. Quality system elements reviewed include: annual product reviews, compliant files, discrepancies and failure investigations, change control, reprocessing, returns/salvages, stability testing, quarantine systems, and validation/verification. Complete Course Information and Registration

We recommend individuals complete the pre-requisite courses before proceeding to the USFDA GMP Inspection Approach online courses. However, there are options for maximizing and customizing your professional development:

Suggested Prerequisites:

Suggested Electives:

Recommended ISPE Resources

Community of Practice:

Knowledge Briefs:

Mini Regulation Handbooks:

Guidance Documents:

Indicates content available to ISPE members only.


  • Click to go to My Communities of Practice
  • Click to go to My Affiliate or Chapter
  • Click to go to My Profile



Design Considerations for WFI Distillation Systems Part 4
Thursday, 26 May 2016 13.05

Direct Access to Quality Manufacturing Experts
Wednesday, 25 May 2016 13.05

Broadening Pharmaceutical Training Footprint in Europe
Tuesday, 24 May 2016 19.05