EU GMP Annex 1 Changes-Clarification and Impact - Baltimore, MD
: 6 May 2019 - 7 May 2019
: Baltimore, United States
The Annex 1 revision represents the latest global regulatory thinking in regards to manufacturing medicinal products. This major proposed revision includes input from all PIC's member countries including US, Europe and others.
This revision now applies to sterile, low bio-burden and terminally sterilised products.
The EU/GMP Annex 1 revision links to ICH Q8, Q9 and Q10. The technical requirements for manufacturing medical products expect the implementation of Quality Risk Management (QRM-ICH Q9) within a Pharmaceutical Quality System (PQS-ICH Q10). This applies across the entire lifecycle of the product as defined in Pharmaceutical Development (ICH-Q8).
In this two day intensive workshop the following will be addressed:
- Details related to the change between the proposed revision to Annex 1 and the 2008 revision.
- Impact of each important change will be addressed with relevant case studies which will have bearing on your facilities processes and policies.
- Real world assessment with pertinent standards and guidances that can provide information on assessing contamination risks.
- Discussion on how to implement the proposed contamination control strategy.