Dr. Rainer Gnibl
GMP Inspektor, Regierung von Oberbayern
Referent:innen
Dr. Sabine Hauck
dequra pharma consult hauck, Chair of ECA ATMP Interest Group
Dr. Katja Aschermann
TETEC
Dr. Wolfgang Schumacher
ehem. F. Hoffmann-La Roche
Kati Kebbel
Fraunhofer-Institut für Zelltherapie und Immunologie IZI
Dr. Ulrike Herbrand
Charles River Laboratories Germany
Mag. Gabriela Schallmeiner
Inspection Ready Consulting, Austrian Qualified Person Association (aqpa)
All times mentioned are CEST.
Zielsetzung
As part of this GMP course for ATMPs (Advance Therapy Medicinal Products), you will learn about the existing regulatory requirements for aseptic manufacturing, CCS, data integrity, lyophilisation according to the new Annex 1 and much more from various experts from authorities, industry and consulting. In addition to the GMP requirements, you will also learn about the impact and implementation of the new Annex 1.
Hintergrund
The new Annex 1 is in effect and must now be implemented. The correct interpretation and implementation in daily business is often difficult and raises many questions. Compliance with the GMP regulations is essential for the continuous, traceable and high-quality manufacture, testing and control of pharmaceutical products.
New ATMPs with new special features are constantly being created. Whether this is a personalized product, the production or even the transport is irrelevant. The ultimate goal should be a safe, effective preparation that offers the patient a cure or relief without harming them. To achieve this, employees must adhere to basic rules. This course offers deeper insights into the regulations and advice on implementing the new and existing requirements of ATMPs.
New ATMPs with new special features are constantly being created. Whether this is a personalized product, the production or even the transport is irrelevant. The ultimate goal should be a safe, effective preparation that offers the patient a cure or relief without harming them. To achieve this, employees must adhere to basic rules. This course offers deeper insights into the regulations and advice on implementing the new and existing requirements of ATMPs.
Zielgruppe
This training is aimed at employees from quality assurance, quality control and production who have daily contact with ATMPs and have to work according to the existing GMP requirements. Experienced staff will have the opportunity to extend and deepen their existing knowledge in core aspects of GMP and Annex 1 Areas.
Technical Requirements
We use WebEx for our live online training courses and webinars. At https://www.gmp-compliance.org/training/online-training-technical-information you will find all the information you need to participate in our trainings and you can check if your system meets the necessary requirements to participate. If the installation of browser extensions is not possible due to your rights in the IT system, please contact your IT department. WebEx is a standard nowadays and the necessary installation is fast and easy.
Programm
Gesamtes Programm als PDF herunterladen
EU-GMP Guideline Part IV: Overview
- Positioning within EudraLex Vol. 4
- Definition of ATMPs
- Document structure & technical content
- Key messages
Quality Risk Management for ATMPs
- What does QRM mean?
- ICH Q9 Quality Risk Management (Overview)
- Bounderies & Limitations
- Examples from Guideline
Freeze-drying of Vectors in the Light of Update Annex 1
- Annex 1 requirements for lyophilization
- Further regulatory requirements for (non-)viral vectors
- Benefits of freeze-dried viral vector formulations
Aseptic Manufacturing of Cell-based ATMPs (HCGTP)
- Challenges
- Impact of new Annex 1
- Cross Contamination Control Strategy
Environmental Monitoring
- Segregation between Classification, Qualification & Monitoring
- Clean room lifecycle
- Monitoring elements
- Personell & clean room monitoring
Data Integrity of Automated, Decentralised Cell Therapy Production
- DI concept in research-oriented smaller companies
- Computer-assisted manufacturing of therapeutics
- DI issues in testing, release and logistics
- DI questions in the context of inspections
Contamination Control Strategy
- Definition
- Creation of a CCS
- Selected items
Qualification and Validation – a Versatile and Efficient Quality Tool in the ATMP Manufacturing
- Clarification of types of qualification and validation applied in ATMP manufacturing
- supplier qualification
- device qualification
- software validation - (Aseptic) process qualification / Validation
- method Validation
- operator qualification - Regulatory basis
- How are these types used in the ATMP manufacturing - described in a case study for a clinical phase I/II ATMP
Bioassay Challenges
- Principles and regulatory environment of bioassays
- Matrix approach
- Case studies for various types of ATMPs
Batch Release - What to Consider for AT(I)MPs
- EU Regulatory framework
- GMP for AT(I)MPs
- QP batch certifcation
| 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
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Tel.: +49 6221 84 44 0
E-Mail: info@concept-heidelberg.de
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