EU GMP Annex 1 - What's New for Sterile Product Manufacturing?
Duration: 60 Minutes
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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.
03/15/2018 10:00 AM03/15/2018 04:00 PMTraining Topic: EU GMP Annex 1 - What's New for Sterile Product Manufacturing?Instructor: Tim Sandle
Objectives of the Presentation
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
Why Should you Attend
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.
Sterile products manufacture
Corrective and preventive actions for contamination incidents