GMP Internal Auditor
Mastering Pharmaceutical GMP Auditing with ISO 19011 Training and Practical Case Studies.
This course is specifically designed to provide you with the essential skills to plan and conduct GMP self-inspection and internal audits with improved ability and confidence that will satisfy regulatory authority expectations.
Learn how to set a risk-based annual self-inspection audit programme and plan and conduct effective self-inspection internal audits that give precise, evidence-based non-conformances to your auditee.
Delivered by world-class tutors who can engage learners and pay-forward their experience for the next generation of auditors, this course uses participative learning techniques and real-world auditing case studies to drive the learning experience, enabling learners to practice realistic auditing techniques in a safe learning environment.
Key Topics
This course covers the below topics. All sessions have practical learning exercises to help reinforce new skills and allow delegates to apply the techniques.
Day 1
- Types of audits
- GMP auditing standards and guidelines
- Setting up and managing a risk-based annual audit programme
- The audit cycle (planning, initiating, conducting audits)
- Preparing and planning for your audit
Day 2
- Checklists
- Auditing techniques and auditor competencies
- The audit process (opening meetings, the audit, closing meetings)
- Writing clear non-conformances
- Audit role play
- Writing concise audit reports and follow-up
Learning Outcomes
This course will enable you to:
Who should attend?
- Auditors and audit teams at the Foundation-Practitioner level of experience, who require engaging, participative learning to achieve a competence to Internal Auditor level.
- GMP/QA professionals, responsible for managing and conducting self-inspection audits of the company’s GMP Pharmaceutical Quality System, who have yet to have any formal training, or who wish to improve or refresh their auditing skills.
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