The GMP-Auditor

21-23 May 2025, Barcelona, Spain

Course No. 21576

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Speakers

Dr. Christian Hösch

Dr. Christian Hösch

Behörde für Justiz und Verbraucherschutz (BJV)

Stefan Reintgen

Stefan Reintgen

Team Connex

Thomas Højsholm Schmidt

Thomas Højsholm Schmidt

CSL Behring

Charis Schmidt

Charis Schmidt

Entourage

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.

Target Group

GMP Auditors from pharmaceutical and API industry.

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.

Programme

The GMP-Auditor

Seminar Programme as PDF

How to Optimise the Audit Programme
  •  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

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This course is part of the GMP Certification Programme "ECA Certified GMP Auditor" Learn more

ECA-Member*: € 2090,-
Non ECA Member*: € 2290,-
EU/GMP Inspectorates*: € 1145,-
APIC Member Discount*: € 2190,-

(All prices excl. VAT). Important notes on sales tax.

* also payable by credit card
American Express Visa Mastercard

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Further dates on-site
Further dates on-site
Not available
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Further dates online
Further dates online
Not available
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Recording
Not available

Do you have any questions?

Please contact us:
Tel.: +49 6221 8444-0
E-Mail: info@gmp-compliance.org

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Testimonials about our courses and conferences

“Fantastic course – I really enjoyed the interactive structure & greatly appreciate social activity.”

Anthony Cummins, Sebela Pharmaceuticals, Ireland
GMP Auditor Practice, September 2023

 

“Very well organized, information on point without being overwhelming.”

Eleni Kallinikou, Pharmathen
Live Online Trainng - Pharmaceutical Contracts - Febuary 2024

 

“Good overview of different types of agreements, good to see both the GMP and the legal angle”

Ann Michiels, Johnson&Johnson
Live Online Trainng - Pharmaceutical Contracts, Febuary 2024

 

 

“Well prepared presentations and good presenters. I also like the way of asking questions.”

Alexandra Weidler, Hookipa Biotech GmbH, Austria
Live Online Training – QP Education Course Module A, November 2023