Dr. Sabine Hauck
dequra pharma consult hauck, Chair of ECA ATMP Interest Group
Referent:innen
Dr. Rüdiger Alt
Novartis
Dr Ulrich Kissel
European QP Association (EQPA), KisselPharmaConsulting
Dr Rainer Gnibl
GMP Inspector
Zielsetzung
In this basic GMP course for ATMPs (Advanced Therapy Medicinal Products), experts from authorities, industry and consultancy will explain the basic GMP requirements for working with ATMPs. In addition, you will gain an understanding of the most important regulatory requirements in this area.
Hintergrund
Advanced therapy medicinal products (ATMPs) play a key role in innovative, personalized medicine. They are leading biomedical research and providing breakthrough treatments for serious and often incurable diseases. These therapies include CAR-T cells, viral vectors (AAV, lentiviruses, adenoviruses), plasmid DNA and tissue engineering, all driven by advances in genetics, molecular biology and cell biology.
GMP compliance is essential for the consistent, traceable manufacture and control of medicines. To achieve this, employees must understand the basic rules. In practice, this understanding is often incomplete. This training gives you an insight in the GMP rules for ATMPs starting from the Basics.
GMP compliance is essential for the consistent, traceable manufacture and control of medicines. To achieve this, employees must understand the basic rules. In practice, this understanding is often incomplete. This training gives you an insight in the GMP rules for ATMPs starting from the Basics.
Zielgruppe
This basic course is aimed at Quality Assurance, Quality Control and Production personnel who work with ATMPs on a daily basis. This course will refresh or create a basic understanding of GMP with a focus on ATMPs.
This course provides new employees and employees in their first years of employment with an initial insight into GMP regulations, as well as the day-to-day characteristics and GMP-compliant handling when working with ATMPs.
This course provides new employees and employees in their first years of employment with an initial insight into GMP regulations, as well as the day-to-day characteristics and GMP-compliant handling when working with ATMPs.
Date / Venue / Presentations / Certificate
Tuesday, 14 October 2025, 09.00 h – 17.00 h
(Registration and Coffee 8.30. h – 09.00 h)
Wednesday, 15 October 2025, 08.30 h – 17.00 h
All times mentioned are CEST
Intercity Hotel Heidelberg
Kurfürsten-Anlage 81
69115 Heidelberg, Germany
Phone: +49/6221/1881 0
Email: heidelberg@intercityhotel.com
(Registration and Coffee 8.30. h – 09.00 h)
Wednesday, 15 October 2025, 08.30 h – 17.00 h
All times mentioned are CEST
Intercity Hotel Heidelberg
Kurfürsten-Anlage 81
69115 Heidelberg, Germany
Phone: +49/6221/1881 0
Email: heidelberg@intercityhotel.com
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.
After the event, you will automatically receive your certificate of participation.
Programm
Gesamtes Programm als PDF herunterladen
GMP – A first Approach
Dr Sabine Hauck
Dr Sabine Hauck
- Definition, context and history
- What makes GMP so special?
- GMP outside Europe
ATMPs – Modern Medicines between Cells and Genes
Dr Sabine Hauck
Dr Sabine Hauck
- To be or not to be - which products belong to ATMPs?
- A decision tree to help you
- Regulation 1394/2007
Risk-based Approach
Dr Sabine Hauck
Dr Sabine Hauck
- Flexibility and responsibility
- Understanding of processes and products as a prerequisite
- Application and examples
Outsourced Activities
Dr Ulrich Kissel
Dr Ulrich Kissel
- Scope and importance
- Supplier Management
- Specification Management
- Change control
Personnel & Rooms
Dr Rainer Gnibl
Dr Rainer Gnibl
- Requirements for ATMP personnel
- „Shared“ or “dedicated” facilities?
- EU-GMP compliant design
Equipment - Single Use and more
Dr Ulrich Kissel
Dr Ulrich Kissel
- Scope and importance
- Sterility Management
- Handling SUS in storage and operation
- Special features, Teflon
Aseptic Environment, Environmental Monitoring and (Cross-)Contamination
Dr Rainer Gnibl
Dr Rainer Gnibl
- Principles of particulate and microbiological Monitoring
- Avoidance of (cross) contamination
- Basics of aseptic production
Handling of Raw/Starting Materials, Cell Bank System and more
Dr Rainer Gnibl
Dr Rainer Gnibl
- Requirements for various materials
- Incoming goods
- Traceability
Quality Control
Dr Ulrich Kissel
Dr Ulrich Kissel
- Scope and importance
- Pharmacopoeia Europaea
- Samples and their handling
- Method validation and method transfer
Qualification & Validation
Dr Rainer Gnibl
Dr Rainer Gnibl
- Cleanroom qualification
- Basics of process and cleaning Validation
- Aseptic validation (media fill)
- Validation life cycle
Batch Release
Dr Rüdiger Alt
Dr Rüdiger Alt
- Batch certification and release by the EU QP
- Batch certification before fully completed testing
- Decentralized production
Handling of unplanned Deviations
Dr Rüdiger Alt
Dr Rüdiger Alt
- Recording and documentation
- Initial evaluation and classification
- Root Cause Investigation & CAPA
Handling of OOS Results
Dr Rüdiger Alt
Dr Rüdiger Alt
- OOS investigation and risk assessment
- Exceptional provision request
- Exceptional batch supply and notification to authorities
Often forgotten GMP Areas
Dr Ulrich Kissel
Dr Ulrich Kissel
- Reconstitution after batch release
- Data with regards to ATMPs and GMP Annex 11
- Temperature management - Is it really necessary?
- Purchasing and Supply Chain Management and GMP
Specific Guidelines for selected Product Types
Dr Sabine Hauck
Dr Sabine Hauck
- Supplementary requirements for manufacture and Control
- Requirements for product properties and characterization
- Examples for product-related guidelines
| ECA-Member*: | € 1690,- |
| Non ECA Member*: | € 1890,- |
| EU/GMP Inspectorates*: | € 945,- |
| APIC Member Discount*: | € 1790,- |
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
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Aufzeichnung nicht verfügbar
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E-Mail: info@concept-heidelberg.de
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