Our Pharma Internal Auditor course is aimed at people who perform internal and external audits, people who manage audit programmes as well as individuals who host auditors of their own organisation.
Course overview:
This Pharma Internal Auditor course is designed for those new to auditing. The course covers how to plan, perform, report and follow-up audits professionally. Delegates will learn about GMP and how to audit against GMP (as a standard) as well as the newer requirements of Q10 (Quality Management) and the ramifications of this document to GMP, including recent updates to EU GMP Chapters 1 and 2.
Course contents:
Day 1 Quality Management Systems and auditing
Quality Management Systems and their evolution
GMP – structure and legal status
Types of audits and reasons for performing them
GMP requirements for internal and supplier audits
GMP and Pharmaceutical Quality Management development
ICH Q9 and 10
An overview of ISO 9001 and how many of its requirements are incorporated into ICH Q10
Effective audit planning and preparation
Day 2 The audit process
Review of documentation before the audit
Good auditing techniques
Checklist construction
The opening meeting
Audit role-play exercise
The closing meeting
Finding faults and identifying opportunities for improvement
