Hazard Analysis and Product Risk Management Under ISO 14971 and ICH Q9 2019 is a webinar that covers topics such as:
- Suggested formats
- Key requirements of ISO 14971 (2007 and 2012); ICH Q9
- What to include
- Expected sources of information to evaluate
- An often neglected safety feature
- How to complete, document, and control
- A "living" useful, cost-saving document
Hazard Analysis and Product Risk Management Under ISO 14971 and ICH Q9 2019 is intended for:
- Regulatory Affairs
- Senior management
- Production
- Quality Assurance
- Sales and Marketing
- Engineering
- All personnel involved in a U.S. FDA- and/or EU ISO 13485/MDD-regulated environment
