Initial and Continuous Professional Training for GMP Auditors
5-7 May 2026, Berlin, Germany
Course No. 22137
Speakers
Dr Christian Hösch
Behörde für Justiz und Verbraucherschutz (BJV)
Stefan Reintgen
Team Connex
Thomas Højsholm Schmidt
CSL Behring
Charis Schmidt
Ferring
- Efficiency in Audit Planning and Performance - Global Auditing - Communication and Conflict Management
Target Group
GMP Auditors from pharmaceutical and API industry.
Objectives
In this training course you will learn
How to plan and conduct audits efficiently
How to face various audit challenges
What communication techniques are needed
How you can avoid and solve conflicts
Background
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.
Programme
How to Optimise the Audit Programme
Who needs to be audited
The Audit Programme
How to optimise the Programme
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
Further Information
Venue HYPERION Hotel Berlin Prager Straße 12 10779 Berlin, Germany +49 (0)30 236 250 0 hyperion.berlin@h-hotels.com
Accommodation CONCEPT HEIDELBERG has reserved a limited number of rooms in the conference hotel. You will receive a room reservation form/POG when you have registered for the course. Reservation should be made directly with the hotel. Early reservation is recommended.
Fees (per delegate, plus VAT) ECA Members € 2,290 APIC Members € 2,390 Non-ECA Members € 2,490 EU GMP Inspectorates € 1,245 The conference fee is payable in advance after receipt of invoice and includes dinner on the first day, lunch on all three days and all refreshments. VAT is reclaimable.
Social Event On 05 May, you are cordially invited to a social event (city tour and dinner). This is an excellent opportunity to share your experiences with colleagues from other companies in a relaxed atmosphere.
Presentations/Certificate The presentations for this event will be available for you to download and print before and after the event. Please note that no printed materials will be handed out on site and that there will not be any opportunity to print the presentations on site.
After the event, you will automatically receive your certificate of participation.
Conference language The official conference language will be English.
Testimonials
