Initial and continuous professional training for auditors is of utmost importance as the authorities expect highly qualified personnel performing audits. Therefore, ECA has developed the programme at hand to give you a detailed overview about important matters to consider and to discuss important tasks and challenges like:
Expectations of the authorities
Audit types
Risk-based audit planning
Audit plan and audit team
Audits in China, India and South America
Categorisation of audit findings
Auditor skills and technical knowledge requirements
Communication skills
Conflict solving
In a special Audit Simulation Workshop with role plays and video feedback, you will be able to deepen your skills and knowledge.
Target Group
GMP Auditors from pharmaceutical and API industry.
Date & Venue
Date Wednesday, 21 May 2025, 9.00 h – 18.00 h (Registration and coffee 8.30 h - 9.00 h) Thursday, 22 May 2025, 9.00 h – 17.30 h Friday, 23 May 2025, 8.30 h – 15.30 h
Venue Radisson Blu Scandinavia Hotel Amager Boulevard 70 2300 Copenhagen S Denmark Tel +45 (0) 33 96 50 00
Part I: Who needs to be audited - Legal basis for audits - Community project: Evaluation of supplier audits in Europe
Part II: The Audit Programme - How to set up a risk-based Audit programme - Expectations from a GMP Inspectors point of view
Part III: How to optimise the programme - Third Party, joint- and shared audits - EU-GMP Certificates and CEPs
Part IV: What can go wrong
How to Plan an Audit
Audit program to audit plan
Setting audit scope
Selecting the auditor/team
Defining roles in the audit team
Gathering Information
Preparing an audit plan/agenda
Interactive part
Workshop: Categorisation of various Audit Findings Based on typical audit situations and real case studies, proposals on how to evaluate the given examples will be developed in small working groups. Possible follow-up activities will be discussed.
Distant Assessments and the Combination with on-site Audits
Distant Assessments as part of the overall supplier qualification system
Possibilities and limits of distant assessments
Distant Assessments in combination with on-site audits
Tips for technical implementation
The Auditor – what makes you a good Auditor
Auditor skills
Auditor technical knowledge
Auditor training
Mistakes auditors make
Interactive Sessions on Communication Skills 1. The challenge of appropriate communication 2. How to recognise, understand and solve conflicts 3. Body language 4. Questioning techniques
Suppliers from China, India and South America
How to prepare audits abroad
Challenges and pitfalls
Typical compliance issues: what to look for
Cultural particularities
Audit Simulation Workshops
Role plays
Video feedback
Selected working groups will simulate pre-defined audit situations. The experience and performance will be evaluated and discussed with the team.
Audit Report Writing
How to take proper audit notes
Best practices for audit report writing - Using standardised report templates - How to generate a clear and concise list of findings - Phrases that should be avoided - Purpose and conclusion
When is a report final?
Timelines for finalisation, distribution, feed-back and follow-up
Difference between internal and external audit report
This course is part of the GMP Certification Programme "ECA Certified GMP Auditor" Learn more
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Testimonials
Seminar Programme as PDF