GMP-Auditor Practice

8-10 October 2024, Barcelona, Spain

Course No. 21293



Dr Agnes Kis

Dr Agnes Kis

Compliance Consultant, formerly F. Hoffmann La-Roche

Thomas Højsholm Schmidt

Thomas Højsholm Schmidt

CSL Behring

Christof Langer

Christof Langer


Energy Kristina Hansen

Energy Kristina Hansen

Novo Nordisk


You will have the possibility to learn and intensively discuss
  • how to focus on specific GMP related aspects
  • how to act and react in an audit


Continuous professional training for auditors and lead auditors is of utmost importance as the authorities expect qualified per- sonal performing audits. And GMP audits of suppliers, contract manufacturers and contract laboratories are a fundamental part of a Quality Management System to assure the quality of a drug product. Only knowledgeable and highly qualified auditors with a profound technical knowledge and good communication skills can guarantee audits that are useful for both the auditing com- pany and the auditee.

Recognising this need for further professional knowledge devel- opment, the ECA Academy has set up this practice-oriented course which is also part of ECA’s Certified GMP Auditor Pro- gramme.

Target Group

This course is designed for both new and experienced auditors. It can also be seen as an addition to the ECA Course “The GMP Au- ditor”.


GMP-Auditor Practice

Seminar Programme as PDF

The Root Cause of Poor Personnel Related Discrepancies
  • ƒ Introduction – humans are rational!
  • ƒ An explanation for undesirable behaviour
  • ƒ Utilising behaviour science models to change behaviour
  • ƒ The 3BMethod
How to Audit Quality Systems
  • ƒ What should be included in a Quality System’s audit
  • ƒ Pitfalls when auditing Quality Systems
  • ƒ How to detect Quality System issues
How to Audit Production of Solid Dosage Forms
  • ƒ Risk-based approach
  • ƒ Key points to consider
  • ƒ Exercise with role play
How to Audit Production of Sterile Dosage Forms
  • ƒ Key essentials and points to consider
  • ƒ Case studies
How to Audit Data Governance and Data Integrity
  • ƒ Examples of data governance and data integrity issues
  • ƒ Implications of data integrity issues
  • ƒ Auditors role in data integrity governance
  • ƒ Developing a data integrity audit program – “Hands-on Approach”
How to Perform an API Site Audit
  • ƒ Chemical Synthesis
    - Dedicated vs. multiple purpose facility
    - Material dispensing
    - Cross-Contamination
    - Process and cleaning Validation
    - Utilities
  •  Biotechnology
    - Cell Banks
    - Inoculation
    - Fermentation
    - Harvest
    - Purification
How to Perform Quality Control Laboratory Audits
  • ƒ Sample receipt and registration
  • ƒ Sample preparation
  • ƒ Equipment Calibration and Maintenance
  • ƒ Reporting
How to Audit Engineering and Technical Operations
  • ƒ HVAC systems
  • ƒ Water systems
  • ƒ Utilities
    - Pressured air
    - Clean steam
    - Special gases
  • ƒ Room qualification
  • ƒ Facility Layouts
  • ƒ Flow of material and waste
How to Audit Microbiological Laboratories
  • ƒ Where to look at
  • ƒ Interpretation of microbiological Data
  • ƒ Examples
How to Deal with Challenging Personalities in the Audit Room
  • ƒ Introduction: people are strange!
  • ƒ Top 10 most frustrating, difficult, or annoying personalities in an audit and how to deal with them


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

Further dates on-site
Further dates on-site
Not available
Further dates online
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Do you have any questions?

Please contact us:
Tel.: +49 6221 8444-0

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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