QUANTITATIVE EVALUATION AND MANAGEMENT of Cross Contamination Risks in Multi-Product Facilities 2015

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.

Key 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.