Dr. Bettina Rietz-Wolf
Regierungspräsidium Tübingen
Referent:innen
Dr Rainer Gnibl
GMP Inspector
Dr. Ingrid Walther
Pharma Consulting Walther
Arjan Langen
GE Healthcare
Robert G. Schwarz
GXP-TrainCon
Carsten Moschner
CMC3
Dr. Daniel Müller
GMP Inspector
Dr. Philip Hörsch
Vetter Pharma-Fertigung
Matthias Schaar
Novartis
Dr. Jürgen Blattner
BSR
Stephan Löw
CSL Behring
Zielsetzung
This Live Online Training offers you a unique opportunity to familiarize yourself with the new regulatory requirements of the revised final Annex 1, the impact on aseptic manufacturing, terminal sterilization and the challenges related to quality aspects. Still need to implement some points and need suggestions? Or you would like to review your approach and compare it with the experience of colleagues and inspectors?
Speakers from the authorities as well as representatives from the pharmaceutical industry and experts from technical suppliers will present their views and experiences in areas such as quality risk management, process simulation, as well as the challenging topics PUPSIT and CCIT. In addition, the much-discussed topic of contamination control strategy will be addressed and solutions presented.
The classic topics of contamination control such as environmental monitoring, cleaning and disinfection, personnel hygiene will also be discussed with you.
Speakers from the authorities as well as representatives from the pharmaceutical industry and experts from technical suppliers will present their views and experiences in areas such as quality risk management, process simulation, as well as the challenging topics PUPSIT and CCIT. In addition, the much-discussed topic of contamination control strategy will be addressed and solutions presented.
The classic topics of contamination control such as environmental monitoring, cleaning and disinfection, personnel hygiene will also be discussed with you.
Hintergrund
The aseptic filling of a sterile product must be performed in a controlled environment. (Grade A clean room in a corresponding classified environment). The most relevant part of the EU GMP Guide for this type of production is Annex 1 of this Guide. After a long revision period of the previously valid 2008 version and two rounds of comments, the long-awaited revised Annex 1 for the manufacture of sterile medicinal products was finally published by the European Commission on August 25, 2022. The main reason for the update was to reflect changes in the regulatory environment and new developments in manufacturing technologies, which include a significant shift towards the application of quality risk management principles. The new Annex 1 is into force since August 25, 2023.
Zielgruppe
This Live Online Training is of interest to professionals from
- Pharmaceutical and biopharmaceutical manufacturers,
- Authorities 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
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.
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.
Programm
Future Sterile Manufacturing – some Thoughts about the Annex 1 Changes
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
Comparison of Annex 1 with other Relevant Documents
- Clean room grades
- Gowning
- Monitoring
- Trending
Recording from 4/5 July 2024
Duration of Recording: 11h 41min
| ECA-Member*: | € 1690,- |
| Regular Fee*: | € 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
Weitere Termine online nicht verfügbar
This course is part of the GMP Certification Programme "ECA Certified Sterile Production Manager"
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Wir stehen Ihnen für weitere Auskünfte gerne zur Verfügung.
E-Mail: info@concept-heidelberg.de
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