Quality Systems Track

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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.
Last Update: 21 September 2011

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