Lead Auditor Training: Mastering Pharmaceutical Audits

Course Objectives

Participants 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 of AI and other tools in the different audit stages

Course Content

The curriculum combines theoretical foundations with practical exercises, including virtual and role-play audit simulations. Topics include:

• 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

This course is ideal for:

• Quality Assurance professionals,
• Qualified Persons (QPs),
• Regulatory inspectors, self-inspectors, and others involved in supplier or internal audits within the pharmaceutical or medical device sectors.

Prior auditing experience is beneficial but not required.

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Prerequisites

Participants should have at least one year of professional experience in the pharmaceutical or medical device industry, with foundational knowledge of GMP (EU/US), GDP, Completion of an intermediate QMS/GMP/GDP course is recommended.

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Meet your instructors ‍

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Magnus Jahnsson

Magnus is a Principal Consultant & Auditor at Epista.

He holds a Master of Science in Materials engineering from the Royal Institute of Technology (KTH) in Stockholm and a University Certificate in Psychology from Stockholm University.

He has more than 30 years of experience with Quality and Compliance.

Previously he was Director Training and Courses with Key2Compliance. He is a highly appreciated manager, trainer, and auditor. Other selected positions to mention are:  Director Regulatory Affairs with Pharmadule Morimatsu, Vice President, Quality & Validation, Pharmadule AB; Scientific Administrator with the European Medicines Agency (EMA). He also held positions in R&D and operations with AstraZeneca.

Magnus has trained and practised as an operational-development coach and have given a number of lectures and courses for ISPE and other organisations and is certified to become an IRCA-accredited ISO-auditor.

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Per H. Damgaard

Dr. Per H. Damgaard is Vice President for Training, Education & Audit at Epista.

He has a PhD in microbiology from the former Royal Veterinary and Agriculture University of Copenhagen (now University of Copenhagen). During his studies he spent time at Washington State University (Pullman, USA), National Research Council (Ottawa, Canada) and DLO Research and Institutes (Wageningen, Holland). Before leaving the world of academia he was employed as Assistant Research Professor at RVAU.

Dr. Damgaard has more than 25 years of experience from the pharmaceutical industry where he has worked in both managerial roles (Vice President, Director and Department Manager) as well as subject matter expert positions. He has experience from both Drug Substance and Drug Product manufacturing, from QA and QC, as well as a GMP auditor in both drugs and medical devices.

Dr. Damgaard has been a professional trainer in GMP since 2010 and has held our open courses as well as many internal company courses.

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