Curriculum
Course Description:
This course introduces the audit process, planning, data review, reporting and CAPA. Participants will experience applicable template based discussions on theoretical aspects of audit fundamentals.
After completing this course, participants will be able to:
- Explain requirements of self -inspections and process audits
- Describe requirements of the audit process
- Summarize how audits are conducted and how audit reports are prepared.
- Apply knowledge of the audit process via case studies as edited excerpts from 483/WL
Who should participate:
- QA/QC Engineering
- QA/QC Production
- QA/QC Analytical
- RA / transitioned into QA role from other functions
The live version of this recording took place on February 8, 2022
Access Duration:Access to this course expires 60 days from the date of registration or until you mark the course ‘Complete’ – whichever occurs first.
USP Approved Instructor
Stephen W. Andruski, Ph.D.
Senior Manager, Verification Programs,
U.S. Pharmacopeia
Ph.D., Organic Chemistry, University
of Arizona