ISO 14971:2007 webinar / training

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.

You will learn here

  • 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.

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