Conference Description:
In this Product Risk Management webinar learn how to develop and implement product risk management planning. Understand the Key requirements of ISO 14971 and ICH Q9.
Areas Covered in the Seminar:
- Key requirements of ISO 14971 and ICH Q9.
- Suggested formats to meet both FDA and MDD requirements.
- Expected sources of information for evaluation and inclusion.
- How to compile.
- When to involve the team.
- How to complete, document and control as a 'living' document.
- An often neglected safety feature.
- Effectiveness -- Determining and Monitoring.
- Realizing real cost savings.
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