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Build deep auditing capabilities in your organization with this high-end course, tailored specifically to your company’s needs and SOPs. Over 1–3 days, your teams will gain the skills, structure, and confidence to plan and execute audits to the highest industry standards, based on ISO 19011 and GMP guidelines (EU GMP, 21 CFR). The training combines theory, practical exercises, and role-play simulations to create lasting competence development.
Course objectives
Your team will learn how to:
• Plan, conduct, report, and follow up on audits effectively
• Apply ISO 19011 principles within a GMP/PQS framework
• Understand regulatory expectations and risk-based audit planning
• Communicate effectively and manage conflicts during audits
• Evaluate and categorize audit findings
• Write comprehensive and professional audit reports
• Use AI and other tools in the different audit stages
Course content
• Audit Principles and ISO 19011 Framework
• GMP and Pharmaceutical Quality Systems
• Supplier and Contract Manufacturer Audits
• Audit Planning, Team Roles, and Document Review
• Communication, Interviewing, and Conflict Management Skills
• Risk-Based Audit Planning and Categorization of Findings
• International Supplier Audits and Cultural Considerations
• Report Writing and Post-Audit Follow-Up
Target audience
Quality Assurance professionals, Qualified Persons (QPs), Regulatory Inspectors, self-inspectors, and others involved in supplier or internal audits in your company. We recommend classes for between 6-20 people.
Prerequisites
At least one year of professional experience in the pharmaceutical or medical device industry, with foundational knowledge of GMP (EU/US) and GDP. Completion of an intermediate QMS/GMP/GDP course is recommended.
At Epista, our trainers are recognized industry specialists with decades of experience in compliance, auditing, and inspection readiness. They combine deep regulatory knowledge with practical expertise to empower your teams to operate with confidence and pass inspections seamlessly.
We offer training in English, Danish, and Swedish.
Get in Touch
If you want to explore how these trainings and services can support your company, reach out to us, and let’s discuss a tailored plan designed for your organization.