Dr Rainer Gnibl
GMP Inspector
Referent:innen
Dr Sabine Hauck
dequra pharma consult hauck, Chair of ECA ATMP Interest Group
Dr Katja Aschermann
Astator
Dr Wolfgang Schumacher
formerly F. Hoffmann-La Roche
Kati Kebbel
Fraunhofer-Institut für Zelltherapie und Immunologie IZI
All times mentioned are CEST.
Zielsetzung
As part of this GMP course for ATMPs (Advanced 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.
Advanced Therapy Medicinal Products (ATMPs) are a group of innovative and sophisticated medical treatments that use advanced technologies to modify or use living cells, tissues or genes for therapeutic purposes. These therapies focus on targeting the underlying causes of disease at the cellular and genetic level, with the aim of treating, preventing or diagnosing diseases. ATMPs include gene therapies, cell therapies and tissue engineered products and represent a significant step in medical treatments.
New ATMPs with innovative properties are constantly being developed. It does not matter whether it is a personalized product, production or even transport. The ultimate goal always remains a safe and effective product that provides the patient with healing or relief without harming them. To ensure this, employees must comply with the current regulations. 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.
Date & Technical Requirements
Date & Technical Requirements
Date
Wednesday, 29 April 2026, 09.00 h – 16.30 h
Thursday, 30 April 2026, 09.00 h – 16.00 h
All times mentioned are CEST
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.
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.
Programm
Gesamtes Programm als PDF herunterladen
EU-GMP Guideline Part IV: Overview
Dr Rainer Gnibl
Dr Rainer Gnibl
- Positioning within EudraLex Vol. 4
- Definition of ATMPs
- Document structure & technical Content
- Key messages
Quality Risk Management for ATMPs
Dr Rainer Gnibl
Dr Rainer Gnibl
- What does QRM mean?
- ICH Q9 Quality Risk Management (Overview)
- Bounderies & Limitations
- Examples from Guideline
Specific Aspects for Viral and non-viral Vectors
Dr Sabine Hauck
Dr Sabine Hauck
- Points to consider when handling GMOs under GMP
- GMPs and Pharm. Eur. monograph on gene therapy medicinal products
- Viral clearance of viral products
Aseptic Manufacturing of Cell-based ATMPs (HCGTP)
Dr Katja Aschermann
Dr Katja Aschermann
- Challenges
- Impact of new Annex 1
- Cross Contamination Control Strategy
Environmental Monitoring
Dr Rainer Gnibl
Dr Rainer Gnibl
- Segregation between Classification, Qualification & Monitoring
- Clean room LifeCycle
- Monitoring Elements
- Personell & clean room monitoring
Data Integrity of Automated, Decentralised Cell Therapy Production
Dr Wolfgang Schumacher
Dr Wolfgang Schumacher
- DI concept in research-oriented smaller companies
- Computer-assisted manufacturing of therapeutics
- DI issues in testing, release and logistics
- Impact of the revised EU GMP Chapter 4, Annex 11 and new Annex 22
- DI questions in the context of inspections
Contamination Control Strategy
Dr Katja Aschermann
Dr Katja Aschermann
- Definition
- Creation of a CCS
- Selected items
Qualification and Validation – a Versatile and Efficient Quality Tool in the ATMP Manufacturing
Kati Kebbel
Kati Kebbel
- 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
ATMPs – a Challenge for Quality Control
Dr Katja Aschermann & Dr Sabine Hauck
Dr Katja Aschermann & Dr Sabine Hauck
- From product to control strategy via CQAs
- Measurement of quality attributes
- Specifications
- Stability
- Validation
Regulatory Landscape – Opportunities and Challenges
Dr Sabine Hauck
Dr Sabine Hauck
- Overview for ATMPs
- Specific requirements for ATMPs - opportunities and challenges
- Examples on points to consider in CMC
If the Guidelines become a Challenge
Kati Kebbel
Kati Kebbel
- Media Growth Promotion Test according to EP 2.6.1 vs. 2.6.27 and impact to sterility method validation
- APS challenges
- Change of standard APS strategy - a future vision?
Batch Release – Responsibilities and Challenges of a QP Based on Case Studies from an Academic CDMO
Kati Kebbel
Kati Kebbel
- Regulatory landscape batch release process; 2-step-procedure for certification of ATIMPs and sponsor release
- Case Study 1: product certification of an early clinical stage ATIMP - roles of the QP in an academic Project Setting
- Case Study 2: product certification of an early clinical stage IMP with different manufacturing sites – roles of the QP(s) and division of responsibilities
- Case Study 3: product certification - roles of the QP(s) in a pharma project setting
| ECA-Member*: | € 1890,- |
| Non ECA Member*: | € 2090,- |
| EU/GMP Inspectorates*: | € 1045,- |
| APIC Member Discount*: | € 1990,- |
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
Aufzeichnung nicht verfügbar
This course is part of the GMP Certification Programme "ECA Certified Biotech Manager"
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E-Mail: info@concept-heidelberg.de
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