Dr Rainer Gnibl
GMP Inspector
Referierende
Dr Ingrid Walther
Freelance Consultant and GMP Expert, Chair of the ECA Cannabis Working Group
Arjan Langen
MSD
Robert G. Schwarz
GXP-TrainCon
Carsten Moschner
CMC3
Dr Philip Hörsch
Cilag GmbH International
Matthias Schaar
Novartis
Dr Jürgen Blattner
BSR
Stephan Löw
CSL Behring
Dr Bettina Rietz-Wolf
Regierungspräsidium Tübingen
- Requirements on Rooms, Barrier Systems, Processes and Personnel
- Quality Risk Management (QRM)
- Qualification of Sterile Facilities & Utilities
- Contamination Control strategies and measures from A (APS) to Z (zoning)
- Sterile Filtration and Container Closure Integrity and PUPSIT
Zielgruppe
This Live Online Training is of interest to professionals from pharmaceutical and biopharmaceutical manufacturers, authori-
ties and suppliers with responsibilities in
ties and suppliers with responsibilities in
- Aseptic Manufacturing, Quality Assurance, Quality Control, Auditing, Inspections
who are involved in
- Contamination Control, Engineering, Monitoring, Qualification and Validation, Internal Audits, Quality Affairs, Aseptic Process Simulation/Media Fill
Zielsetzung
This Live Online Training offers a unique opportunity to familiarize yourself with the new regulatory requirements of the revised EU GMP Annex 1 and their impact on aseptic manufacturing, terminal sterilization, and quality-related processes. Following an extensive revision process, including two rounds of comments, the revised Annex 1 for the manufacture of sterile medicinal products was published by the European Commission on August 25, 2022. The update reflects changes in the regulatory environment and advances in manufacturing technologies, with a particular focus on the application of quality risk management principles.Aseptic filling of sterile medicinal products must be carried out in a controlled environment, typically a Grade A cleanroom within an appropriately classified area. Against this background, the training addresses the practical challenges of implementing the revised requirements. Whether you still need to implement specific provisions, are looking for practical solutions, or want to review your current approach and compare it with the experience of colleagues and inspectors, this event provides valuable guidance.Speakers from regulatory authorities, the pharmaceutical industry, and technical suppliers will share their perspectives and practical experience on key topics such as quality risk management, process simulation, PUPSIT, and CCIT. The widely discussed topic of the Contamination Control Strategy will also be addressed, with practical solutions presented. In addition, the training will cover essential contamination control measures, including environmental monitoring, cleaning and disinfection, and personnel Hygiene.
The new Annex 1 is into force since August 25, 2023.
The new Annex 1 is into force since August 25, 2023.
Programm
Future Sterile Manufacturing – some Thoughts about the Annex 1 Changes and other related Documents
Contamination Control Strategy - Inspector‘s View on an Overarching Strategy
- Requirements
- Expectations & interpretations
The ECA CCS Guide – a Brief Overview
- Guide scope and purpose
- Structure & content overview
Structure and Design – Practical Aspects for a CCS
- How to develop the strategy
- How to have your documents available and accessible
Aseptic Process Simulation – Annex 1 Requirements
- Requirements
- Expectations & interpretations
Sterile Filtration & Container Closure - Annex 1 Requirements
- Sterile filtration requirements
- Pre-Use-Post-Sterilization-Integrity-Testing (PUPSIT) of sterile filters
- Container Closure Integrity Testing (CCIT
- Visual inspection process
PUPSIT – Annex 1 - Application of Risk Management
- PUPSIT: Risk Assessment for PUPSIT and considerations of associated risks in established processes
CCIT – In the Light of the New Annex 1
- Changed requirements for CCIT in finishing of sterile products
- Holistic and more scientific view on CCI system as now multiple influencing aspects are explicitly addressed
Disinfection – Efficacy Testing and Validation
- Antimicrobial agents and their efficacy
- Testing methods
- Efficacy testing against Isolates
- Validation approach
QRM in Sterile Manufacturing – Industrial Experience
- Strengths and limitations of an EM program
- Trending: detecting changes
- Use of modern technologies
- Response to level excursions
Annex1 vs. ISO 14644-1
Requirements from a Technical Point of View
Requirements from a Technical Point of View
- Accordance and differences
- The issue with the particle sizes
- Qualification challenges
Enhanced Requirements on Facilities and Utilities
- Utilities: water, steam and gases
- Facilities: airlocks and pass boxes ; insertion of barrier technologies
- Implicit requirements
Authorities‘ Point of View on RABS and Isolators
- Requirements for barrier systems in new Annex
- Major changes compared to previous version (Annex 1, 2008)
- Inspector‘s comments on changed requirements
Personnel - Behaviour and Access into Cleanrooms
- Requirements for personnel in new Annex 1
- Developments since version 2008 of Annex 1
- Comments of inspector on implementation
New Requirements on a Cleanroom Garment System as an Essential Element of the Contamination Control strategy
- The ‚new‘ Annex 1
- Contamination control strategy for garments
- Risk management
Environmental Monitoring – Current Methodology and Experiences
- Strengths and limitations of an EM program
- Trending: detecting changes
- Use of modern technologies
- Response to level excursions
Environmental & Process Monitoring - Inspector´s View
- Summary of requirements from entire Annex 1
- Essentials for inspection
Weitere Informationen
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 events 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.
Fees (per delegate plus VAT)
ECA Members € 1,890
APIC Members € 1,990
Non-ECA Members € 2,090
EU GMP Inspectorates € 1,045
The conference fee is payable in advance after receipt of invoice.
Presentations/Certificate
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.
Conference language
The official conference language will be English.
Contacts:
Questions regarding content:
Mr Axel H. Schroeder, +49 6221 84 44-10, schroeder@concept-heidelberg.de
Questions regarding organisation:
Mr Ronny Strohwald, +49 6221 84 44-51, strohwald@concept-heidelberg.de
Datum & Uhrzeiten
Tue, 30 June 2027, 9:00 - 18:00 h
Wed, 01 July 2027, 9:00 - 17:00 h
All times mentioned are CEST.
Wed, 01 July 2027, 9:00 - 17:00 h
All times mentioned are CEST.
Teilnahmegebühr
| 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
This course is part of the GMP Certification Programme "ECA Certified Sterile Production Manager"
Haben Sie noch Fragen?
Wir stehen Ihnen für weitere Auskünfte gerne zur Verfügung.
E-Mail: info@concept-heidelberg.de
Teilnehmerstimmen
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