Internal Auditor

All auditing courses
2 Day/s

CPD Hours: 14

Classroom, online, in-house

This course provides a foundation to the requirements of auditing described in the international standard ISO 19011. The course is focused on pharmaceutical GMP, with emphasis on self-inspections and internal audits and several subjects are explored in detail which helps build up knowledge and confidence in your auditing skills. This course is specifically designed to provide you with the essential skills to plan and conduct audits with improved ability and confidence, ensuring you know how to set an effective audit programme and conduct audits that will satisfy regulatory authority expectations.


This highly participative learning course uses realistic audit case studies, exercises and role play to help you practice key auditing steps in a no risk environment, with supportive feedback provided throughout.


This course is suitable for people who are about to start auditing or who may already have undertaken some audits, but have not yet had any formal training and wish to improve or refresh their auditing skills. So if you are a GMP professional and are required to conduct audits of your internal GMP Quality System, this course is suitable for you and:


  • GMP Professionals who have responsibility for the audit programme
  • GMP auditors
  • Other GMP professionals involved in the GMP audit cycle


This course is specifically designed to provide you with the essential skills to plan and conduct audits with improved ability and confidence, ensuring you know how to set an effective audit programme and conduct internal and supplier audits that will satisfy regulatory authority expectations.

The course covers the following topics:


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


All sessions have practical learning exercises to help the delegates apply the techniques.

    Our course will enable you to:


    • Apply the core regulations and standards you are obliged to audit against.
    • Set an effective risk-based annual audit programme to cover the core GMP system to meet statutory obligations.
    • Plan and conduct individual audits with clear audit criteria and audit agendas.
    • Be able to write clear non-conformances that help the auditee to meet your requirements.
    • Be able to write effective, concise audit reports and follow up actions.
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Special offer

Helping your training budget go further

We offer a number of discounts and specials offers on our training courses including Group booking, NHS and Seasonal discounts.

Meet the tutors

Peter Deegan

Peter is an experienced Pharmaceutical QA professional, with over 30 years GMP, ISO 9001 Quality Systems, audit and training experience.

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