QUANTITATIVE EVALUATION AND MANAGEMENT of Cross Contamination Risks in Multi-Product Facilities 2015 is a workshop dedicated to Cross Contamination Risks in Multi-Product Facilities.
Topics
- Process Issues to consider
- Facility Issues to consider
- Risk Control Examples
- Do not let Culture get in the way
- The Regulator Understanding their needs and how to prepare for an Inspection
- The Quality Risk Management Plan Process
- Changes in the EU cGMP’s, what it means for shared facilities Worldwide review of regulatory changes
- Introduction to concepts
- Basics: Understanding the risk of cross contamination
- ICH Q9 and why it must be the basis for Quality Risk Assessments
Who should Attend
Attendees involved or interested in Compliance, Regulatory, Manufacturing Operations and Facilities Management, QA/ QC and Business development for CMO’s.
