- Date:
-
- Webinar
Annex 1 Intensive Training Course - Live Online Training
- Event location:
- online
- Organizer:
- CONCEPT HEIDELBERG GmbH
Future Sterile Manufacturing – some Thoughts about the Annex 1 Changes and related other 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
Annex 1 vs. ISO 14644-1
Requirements from a Technical Point of View
Requirements from a Technical Point of View
- Conformity 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
CONCEPT HEIDELBERG GmbH
Rischerstraße 8
69123 Heidelberg
Germany
Phone: +49 6221 844415
Fax: +49 6221 844464
email: info@concept-heidelberg.de
Internet: http://www.gmp-navigator.com/
