Christof Langer
OSConsulting
Referent:innen
Dr Agnes Kis
Compliance Consultant, formerly F. Hoffmann La-Roche
Energy Kristina Hansen
Novo Nordisk
Thomas Højsholm Schmidt
CSL Behring
Zielsetzung
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
Hintergrund
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.
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.
Zielgruppe
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
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
Programm
Gesamtes Programm als PDF herunterladen
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
| ECA-Member*: | € 2290,- |
| Non ECA Member*: | € 2490,- |
| EU/GMP Inspectorates*: | € 1245,- |
| APIC Member Discount*: | € 2390,- |
Alle Preise zzgl. MwSt. Wichtige Hinweise zur Umsatzsteuer.
* auch unkompliziert per Kreditkarte bezahlbar
Weitere Termine vor Ort
Weitere Termine vor Ort nicht verfügbar
Weitere Termine online
Weitere Termine online nicht verfügbar
This course is part of the GMP Certification Programme "ECA Certified GMP Auditor"
Haben Sie noch Fragen?
Wir stehen Ihnen für weitere Auskünfte gerne zur Verfügung.
E-Mail: info@concept-heidelberg.de
Für Lieferanten: Ausstellungs- und Sponsoringmöglichkeiten
Seminarprogramm als PDF
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