EU GMP Annex 1 Changes, Clarification and Impact, Cambridge MA
: 28 Mar 2019 - 29 Mar 2019
: Cambridge, United States
How will these changes affect your facility?
The Annex 1 revision represents the latest global regulatory thinking in regards to manufacturing medicinal products. This major proposed revision includes input from all PICs member countries including US, Europe and others.
This revision now applies to sterile. low bioburden and terminally sterilised products.
EU/GMP Annex 1 revision links to ICH Q8, Q9 and Q10. The technical requirements for manufacturing medicinal products expect the implementation of Quality Risk Management (QRM-ICH Q9) within a Pharmaceutical Quality System (PQS-ICH Q10). This applies across the entire life-cycle 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 changes between the proposed revision to Annex 1 and the 2008 version
- Impact of each important change will be addressed with relevant case studies which will have bearing on your facilities, processes and policies.
- Real world risk assessment with pertinent standards and guidances that can provide information on accessing contamination risks.
- Discussion on how to implement the proposed contamination control strategy