Topics
- ICH Q9 for Pharma
- The Revised ISO 14971:2007/9 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
- The Team and It’s Involvement - Who, When and How
- Why and How to use the ISO 14971 "Model" in all Regulated Industries
- Using the Completed Document - It`s Real Value "In the Loop"
Who should Attend
QA, Senior management in Drugs, Devices, Biologics, Dietary Supplements, R&D, RA, Production, Engineering, Consultants and Operations.
