Developing and Using the Product Risk Management File/Report 2015

Topics

• ICH Q9 for Pharma
• The Revised ISO 14971:2007 for Devices
• Design, Process, and Use[r] Failure Mode, Effects and Criticality Analysis
• Product Hazard Analysis
• Suggested Risk Management File / Report, FMECA, FTA Templates
• Fault Tree Analysis
• Using the Completed Document - It`s Real Value "In the Loop"
• The Team and Its Involvement - Who, When and How

Who should Attend

• QA
• Senior management in Drugs, Devices, Biologics, Dietary Supplements
• R&D
• RA
• Production
• Engineering
• Consultants; others tasked with project leadership responsibilities
• Operations