This course provides an overview of deviations, regulatory guidelines, investigation roles and responsibilities as well as stages of investigation. Investigation plans, tools, root cause analysis (RCA) and an overview of CAPA will also be covered.

Subject area:
cGMP
Drug Products & APIs

Objectives (If applicable):
•Explain the regulatory repercussions of incomplete deviation investigations (483’s, WL)
•Demonstrate knowledge of root cause analysis tools and their application for investigation of OOS and deviation through structured exercises and case studies.

Target Audience (If applicable):
GMP Auditors
Regulators
Central Quality Auditors (CQA),
Internal auditors involved with QC/ARD- method validation (MV) laboratory audit
QA , QC, ARD Staff
Microbiologist
Quality staff wants to transition in to auditor roles
Experienced professionals