Introduction
Strong supplier oversight is essential for maintaining GMP compliance in the pharmaceutical industry. This one-day training course is designed for QA professionals, auditors, and technical staff involved in auditing suppliers of raw materials, packaging, contract manufacturing, testing labs, or distribution services.
Whether you are new to auditing or looking to strengthen your risk-based approach, this course will give you the tools, regulatory insight, and confidence to perform effective and compliant supplier audits.
What You Will Learn
- The role of supplier audits within the Pharmaceutical Quality System (EU GMP Chapter 7)
- Regulatory foundations: EU GMP, 21 CFR, ISO standards, and relevant guidance
- How to set up and manage a risk-based audit programme
- Planning and preparing for audits: scoping, documentation review, and logistics
- Effective communication with suppliers — before, during, and after the audit
- How to conduct opening/closing meetings and site tours
- Interview techniques, observation skills, and audit note-taking
- How to classify findings (Critical, Major, Minor, Recommendations)
- Writing clear, objective, and compliant audit reports
Who Should Attend?
- QA professionals responsible for supplier qualification
- New or developing auditors
- Responsible Persons (RP)
- Regulatory, procurement, or technical staff involved in external quality oversight
Course Features
- 1-day, interactive training session
- Based on real-world GMP audits and audit findings
- Includes practical exercises and group discussions
- Available in English or Dutch (course content can be tailored to your site)
- Delivered on-site
Key Takeaways
✅ Understand and apply the principles of risk-based supplier auditing
✅ Be prepared to identify, classify, and report findings that impact GMP compliance
Want to prepare your QA team to conduct effective and inspection-ready supplier audits?