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Subscribe NewsletterProduct Risk Management - ISO 14971:2007
Product Id
:
600053
Overview: This webinar will address the use of the ISO 14971 model to perform and document such activities and the additional actions necessary to make it a useful product reference and training tool.
The U.S. FDA has stated that the use of a medical device entails some degree of risk. In fact, any medical procedure / intervention does. A manufacturer is responsible to identify those risks, and take reasonable steps to mitigate them as far as practical and given the 'state of the art' at the time. ISO 14971 provides an accepted vehicle by which to perform and document such an analysis and is accepted by the FDA. These activities can also be used as a method to train new hires, especially in Marketing, QA/RA, Engineering, and Manufacturing.
The U.S. FDA has stated that the use of a medical device entails some degree of risk. In fact, any medical procedure / intervention does. A manufacturer is responsible to identify those risks, and take reasonable steps to mitigate them as far as practical and given the 'state of the art' at the time. ISO 14971 provides an accepted vehicle by which to perform and document such an analysis and is accepted by the FDA. These activities can also be used as a method to train new hires, especially in Marketing, QA/RA, Engineering, and Manufacturing.
Areas Covered in the Session:
- The Revised ISO 14971:2007
- Product Hazard Analysis
- Design, Process, and Use[r] Failure Mode, Effects and Criticality Analysis
- Fault Tree Analysis
- The Team and It's Involvement – Who, When and How
- Product Risk Management File and Report
- Using the Completed Document – It’s Real Value
- Keeping it "In the Loop"
- A "Living Document"
Who Will Benefit:
- Senior Management, Project Leaders
- Internal / External Auditors and/or Consultants
- Regulatory Affairs
- Quality Systems Personnel / QAE
- New Product Development, Marketing and R&D
- Product and Process / Manufacturing Engineering Staff
- Document Control