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.
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
Quality Systems Personnel / QAE
New product development, Marketing and R&D
Product and Process / Manufacturing Engineering Staff
John E Lincoln is a medical device and regulatory affairs consultant. He has helped companies to implement or modify their GMP systems and procedures, product risk management, U.S. FDA responses. In addition, he has successfully designed, written and run all types of process, equipment and software qualifications/validations, which have passed FDA audit or submission scrutiny, and described in peer-reviewed technical articles, and workshops, world wide.
Compliance4All DBA NetZealous,
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