Christof Langer
OSConsulting
Speakers
Dr Agnes Kis
Compliance Consultant, formerly F. Hoffmann La-Roche
Energy Kristina Hansen
MilCor Consulting
Thomas Højsholm Schmidt
CSL Behring
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”.
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
Programme
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 programme – “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
- Compressed 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
Further Information
Venue
Barceló Hotel Hamburg
Ferdinandstraße 15
20095 Hamburg
Germany
+49 40 22 63 62-0
hamburg@barcelo.com
Barceló Hotel Hamburg
Ferdinandstraße 15
20095 Hamburg
Germany
+49 40 22 63 62-0
hamburg@barcelo.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.
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.
Social Event
On the evening of the first course day, 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.
Fees (per delegate, plus VAT)
ECA Members EUR 2,290
APIC Members EUR 2,390
Non-ECA Members EUR 2, 490
EU GMP Inspectorates EUR 1,245
The conference fee is payable in advance after receipt of invoice and includes conference documentation, dinner on the first day, lunch on both days and all refreshments. VAT is reclaimable.
Presentations/Certificate
The presentations will be made available to you prior to the Live Online Training as PDF files. After the event, you will automatically receive your certificate of participation.
Conference language
The official conference language will be English.
Contacts
Questions regarding content:
Mr Wolfgang Schmitt, +49 6221 84 44-39, w.schmitt@concept-heidelberg.de
Questions regarding organisation:
Ms Isabell Helm, +49 6221 84 44-49, helm@concept-heidelberg.de
The presentations will be made available to you prior to the Live Online Training as PDF files. After the event, you will automatically receive your certificate of participation.
Conference language
The official conference language will be English.
Contacts
Questions regarding content:
Mr Wolfgang Schmitt, +49 6221 84 44-39, w.schmitt@concept-heidelberg.de
Questions regarding organisation:
Ms Isabell Helm, +49 6221 84 44-49, helm@concept-heidelberg.de
Date & Time
Tue, 10 November 2026, 09:00–18:00
Wed, 11 November 2026, 08:30–17:45
Thu, 12 November 2026, 08:30–15:00
Wed, 11 November 2026, 08:30–17:45
Thu, 12 November 2026, 08:30–15:00
Costs
| 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
Additional dates on-site
Additional dates on-site
not available
not available
Additional dates online
Additional dates online
not available
not available
This course is part of the GMP Certification Programme "ECA Certified GMP Auditor"
Do you have any questions?
Please contact us:
Tel.: +49 6221 8444-0
E-Mail: info@gmp-compliance.org
Testimonials
Testimonials about our courses and conferences
