Advanced GMP for ATMPs - Online Training Recording
Perfect your skills in the ATMP world of GMP and Annex 1
Course No. 23011
Speakers
Dr Rainer Gnibl
GMP Inspector
Dr Sabine Hauck
dequra pharma consult hauck, Chair of ECA ATMP Interest Group
Dr Katja Aschermann
Astator
Dr Wolfgang Schumacher
SPC – Schumacher Pharma Consult, formerly F.Hoffmann-La Roche
Kati Kebbel
Fraunhofer-Institut für Zelltherapie und Immunologie IZI
Target Group
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.
Objectives
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.
Background
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.
Programme
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
Specific Aspects for Viral and non-viral Vectors
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)
Challenges
Impact of new Annex 1
Cross Contamination Control Strategy
Environmental Monitoring 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
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
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
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
From product to control strategy via CQAs
Measurement of quality attributes
Specifications
Stability
Validation
Regulatory Landscape – Opportunities and Challenges
Overview for ATMPs
Specific requirements for ATMPs - opportunities and challenges
Examples on points to consider in CMC
If the Guidelines become a Challenge
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
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
Further Information
Technical Details To participate in an on demand training course or webinar, you do not need any software. The recordings are made available via a streaming server. In general, the recording is provided in MP4 format, which any PC (Microsoft Windows, Apple IOS) or tablet can easily display.
Timing and Duration When you register for the on demand Training course or webinar you can decide at what date you want to follow the training course online. For a 1-day training course you will have 2 days in which the stream is available (for 2-day training course 3 days and for a 3-day training course 4 days). Within in this timeframe you can start & stop the stream according to your needs.
In time before the scheduled date (your desired date) you will receive an e-mail from us with a link for direct participation as well as your log-in data.
Please be aware: The recording does not include the Q&A sessions.
Training Course Documentation and Certificate The presentation will be made available as PDF-files via download during the online training course. After the successful completion of the online training, you are able to download the certificate of attendance.
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