GMP-Auditor Practice

11-13 November 2025, Vienna, Austria

Course No. 21934

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Speakers

Christof Langer

Christof Langer

OSConsulting

Dr Agnes Kis

Dr Agnes Kis

Compliance Consultant, formerly F. Hoffmann La-Roche

Energy Kristina Hansen

Energy Kristina Hansen

Novo Nordisk

Thomas Højsholm Schmidt

Thomas Højsholm Schmidt

CSL Behring

Objectives

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

Background

Continuous professional training for auditors and lead auditors is of utmost importance as the authorities expect qualified personnel 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 company and the auditee.

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

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 Auditor”.

Date & Venue

Date
Tuesday, 11 November 2025, 9.00h – 18.00h
(Registration and coffee 8.30h – 9.00h)
Wednesday, 12 November 2025, 8.30h – 17.45h
Thursday, 13 November 2025, 8.30h – 15.00h

Venue
Austria Trend Parkhotel Schönbrunn
Hietzinger Hauptstr. 10-14
1130 Vienna (Wien), Austria
Tel.: +43 (1) 878 04 0
E-Mail: parkhotel.schoenbrunn@austria-trend.at

Programme

GMP-Auditor Practice

Seminar Programme as PDF

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

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

ECA-Member*: € 2290,-
Non ECA Member*: € 2490,-
EU/GMP Inspectorates*: € 1245,-
APIC Member Discount*: € 2390,-

(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
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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

"Great material and speakers" and "Great speakers a lot of experience and sharing"

Felipe Gonzalez, Mucos Emulsionsgesellschaft mbH
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"The lectures were very informative, interesting and entertaining."

Albert Godoy Hernández, Company synaffix
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"Really useful training which I will use in my daily work."

Regina Mommaerts, Galapagos NV
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"Wonderful format of the sessions: Good range of participations and experience in the team. Would love to attend another one soon."

Roopasi Mathi, Wacker Biotech B.V.
Live Online Training - GMP Auditor Practice, October 2024

"Very good balance between general and detailed information"

Dr Ralf Albrecht, Tillotts Pharma AG
Live Online Training - Granulation & Tableting
September 2024

"Nice presentations: easy understanding, quite visual"

Susana Manrique, Boehringer Ingelheim España, S.A,
Live Online Training - Granulation & Tableting, September 2024

“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