Introduction
Internal audits are a cornerstone of an effective Pharmaceutical Quality System. This 1-day interactive course is designed for QA professionals, production or lab staff, and support functions involved in self-inspection activities. Whether you’re starting out or seeking to sharpen your audit approach, this training equips you with the practical skills to conduct meaningful, compliant internal audits aligned with EU GMP and ISO expectations.
What You Will Learn
- The legal and regulatory framework: EU GMP Chapter 1, 21 CFR 211, ISO 9001 and 19011
- How to set up an annual audit plan and perform a meaningful year-end evaluation
- The different types of internal audits (system, departmental, for-cause, SBIP)
- Planning and preparing for audits: scope, checklists, prior findings
- Interviewing skills, audit note-taking, and asking the right questions
- How to classify and rate observations (Critical, Major, Minor, Recommendations)
- Structuring a clear and objective audit report
- Managing audit follow-up and timelines for CAPAs and effectiveness checks
- Conducting opening and closing meetings with impact
Who Should Attend?
- QA staff involved in self-inspections or internal audits
- Production or QC personnel selected as internal auditors
- Responsible Persons or QPs wanting to strengthen their audit program
- Anyone preparing for a regulatory inspection
Course Features
- 1-day, practical training session
- Focus on GMP compliance and audit effectiveness
- Includes case studies and real-world examples
- Delivered on-site
- Available in English or Dutch
Key Takeaways
✅ Build confidence in conducting effective and compliant internal audits
✅ Learn how to identify, report, and follow up on audit findings professionally
Need to strengthen your internal audit program or train a new audit team?