Annex 1 – Changes, Challenges and Consequences - Berlin, Germany
: 28 Nov 2018 - 29 Nov 2018
: Berlin, Germany
Expert speakers, as well as representatives from pharmaceutical industry, will provide you information about the new requirements of the revised Annex 1.
They will discuss the statements of the new Annex 1 on topics like Quality Risk Management, Process Simulation/Media Fill and Container Closure Integrity Testing, as well as the current expectations on premises, cleanroom qualification and the appropriate monitoring.
Additionally, the speakers will compare the requirements of the new Annex 1 with the expectations of other guidance documents like ISO 14644 or the relevant US guidelines.
- Structure, Wording, Definitions - the current Draft
- Classification & Qualification of sterile Facilities & Utilities – Inspector´s view
- Sterilisation and sterile Filtration – Inspector´s view
- Personnel - Clothing, Behaviour and more
- Consequences on Microbiological Contamination Control and Environmental Monitoring expected by industry
- Cleaning and Disinfection – in the light of Annex1
- Media Fill/Aseptic Process Simulation regarding the new Annex 1
- Comparison with other relevant Documents
- Barrier Systems and Isolators
- QRM – Quality Risk Management in the light of Annex 1