Newly Revised Risk Management Standard for Medical Products
The US FDA is increasingly stating that many regulated activities should be “risk-based”. Major resource-consuming activities such as product and process / equipment / facility, and software validation, CAPA investigations, vendor audits can all be tailored to a risk based approach.
- An overview of the new ISO 14971:2007 standard with emphasis on changes from the 2001 version.
- The Hazard Analysis and its source material.
- Use of the Appendices.
- Concept of risk evaluation, control, reduction.
- Risk management tools — FTA, FMECA.
- Residual risk.
- Risk / benefit analysis.
- The Risk Management Plan, File and Report.