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Subscribe NewsletterProduct Risk Management Under ISO 14971:2007 and ICH Q9
Product Id
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600179
Overview: The U.S. FDA has stated that the use of a medical device or pharmaceuticals 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 and ICH Q9 provide accepted methodologies 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. This webinar will address the use of the ISO 14971 and Q9 models to perform and document such activities for any medical product and the additional actions necessary to make it a useful product reference and training tool, and maintain it as a "living document".
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 and ICH Q9 provide accepted methodologies 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. This webinar will address the use of the ISO 14971 and Q9 models to perform and document such activities for any medical product and the additional actions necessary to make it a useful product reference and training tool, and maintain it as a "living document".
Areas Covered in the Session:
- The Revised ISO 14971:2007 for Devices
- ICH Q9 for Pharma
- 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"
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