Overview
Overview
This course builds on the Introduction to Auditing course (QA204) and provides the necessary skills to perform quality inspections. This comprehensive and interactive course trains learners on the planning, execution, reporting, and closure of audits.
Learners will be trained on the FDA audit process and examine case studies of complicated past FDA audits in the pharmaceutical industry. As well, learners will review the expectations of a pre-approval inspection (PAI) and implement their own internal audit process for in-house and for suppliers.
Learning Points:
Learners will be trained on the FDA audit process and examine case studies of complicated past FDA audits in the pharmaceutical industry. As well, learners will review the expectations of a pre-approval inspection (PAI) and implement their own internal audit process for in-house and for suppliers.
Learning Points:
- Audit Administration
- Audit Program Process
- FDA Inspections Process
- Mock Pre-Approval Inspection (PAI)
- Quality System for cGMP Compliance
- Audit of Vendors and Suppliers
- Internal Audits
OUR STUDENTS WORK AT
NAI partners with industry-leading corporations and provides them with ready-on-day-one employees.
