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.

Subject area:
cGMP

Objectives (If applicable):
•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

Target Audience (If applicable):
QA/QC Engineering
QA/QC Production
QA/QC Analytical
RA / transitioned into QA role from other functions