Product Risk Management Under ISO 14971:2007 and ICH Q9 2016 is a webinar that covers topics such as:
- 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
- The Team and It’s Involvement – Who, When and How
- Fault Tree Analysis
- Using the Completed Document – It’s Real Value
- Product Risk Management File and Report
- Keeping it "In the Loop"
Product Risk Management Under ISO 14971:2007 and ICH Q9 2016 is intended for attendees from:
- Internal / External Auditors and/or Consultants
- Senior Management, Project Leaders
- Quality Systems Personnel / QAE
- Regulatory Affairs
- Product and Process / Manufacturing Engineering Staff
- New product development, Marketing and R&D
- Document Control