EU GMP Annex 1 - What's New for Sterile Product Manufacturing?
Duration: 60 Minutes
A major revision is taking place with the European regulations covering the manufacture and distribution of sterile products. This is the first major update in 20 years, with the new draft text bringing in many changes, several of which will be far reaching.
Objectives of the Presentation
Why Should you Attend
- What the new Annex 1 contains and what it excludes
- What are the differences between the new requirements and previous requirements
- The relationship between the Annex and ISO 14644
- Understanding microbiological risks
- Understanding what is required for a contamination control strategy
- New emphasis on quality risk management
To learn about the considerable number of changes made to sterile products manufacturing changes that are forthcoming. Although the Annex is applicable to Europe, it was written in conjunction with U.S. FDA and it signals the latest developments with global regulatory thinking.
Who will Benefit
- Sterile products manufacture
- Aseptic processing
- Environmental monitoring
- Contamination control
- ISO 14644
- Cleanroom classification
- Corrective and preventive actions for contamination incidents
- Quality risk management
- Production managers
- Regulatory personnel
- Business intelligence