Hazard Analysis and Risk Management under ISO 14971:2007/2012

In this webinar attendees will learn how to develop, use and document Hazard Analysis and the Product Risk Management File and Report per ISO 14971:2007/12 and ICH Q9. Also a field-tested (US FDA and EU Notified Body) multi-industry “model” will be presented in detail.
Event Type:
Apr. 28, 2020
10:00 AM PDT | 01:00 PM EDT

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. The degree of risk can be a determinant on the level of failure investigation, validation effort, et al, required of those activities. Expectations for meaningful hazard analysis, hazardous conditions and the resulting product risk management documentation have always existed by regulatory agencies. There is an increased awareness of the importance of design activities to support the production of safe and effective product. Product risk management is a required tool to drive and direct resource constrained product design, manufacture and validation activities, as well as CAPA resolution actions, in the company. Field problems indicate that such activities are not yet adequately planned, executed, and visibility maintained. There is a failure to fully utilize the power of current risk management tools. Effective use of such risk management tools can help address the growing push by the public and the FDA, to “toughen” its approach to product clearance and approval, while reducing liability issues. The resulting documentation can also be used as a method to train new hires, especially in Marketing, QA/RA, Engineering, and Manufacturing.

Any medical procedure / intervention involves risk. A manufacturer is responsible to identify those risks, and take reasonable steps to mitigate them as far as practical (or possible) 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 and by Notified Bodies. A field-tested model is presented which incorporates a Narrative, Hazard Analysis, FTA, three FMECAs, and a Report / Conclusion.

This webinar will address the procedures, provide and discuss suggested templates, necessary to develop or modify and then use the ISO 14971 and Q9 models to perform and document such activities for any medical product. It will examine the additional actions necessary to make it useful as a product reference, for CAPA, root cause / failure investigation, and validation prioritization, and training tool, and how to maintain it as a “living document”.

  • U.S. FDA's expectations
  • The Revised ISO 14971:2007/2012 for Medical Devices
  • ICH Q9 for Pharma
  • The “Narrative”
  • The Product Hazard Analysis
  • Fault Tree Analysis (FTA)
  • Design-, Process-, and Use[r]-Failure Mode, Effects and Criticality Analysis (FMECA)
  • Suggested and Field-tested Risk Management File / Report, FMECA, FTA Templates
  • Why and How to use the ISO 14971 'Model' in all regulated industries
  • Other business reasons for use of the Risk Management File / Report.

  • Senior and middle management.
  • Quality Assurance
  • Regulatory Affairs
  • R&D
  • Engineering
  • Sales and Marketing
  • Operations / Production

John E. Lincoln is principal of J. E. Lincoln and Associates LLC, a consulting company with over 31 years’ experience in U.S. FDA-regulated industries, and 17 years as a full-time consultant. Mr. Lincoln has worked with companies from start-up to Fortune 100, in the U.S., Mexico, Canada, France, Germany, Sweden, China and Taiwan. He specializes in quality assurance, regulatory affairs, QMS problem remediation and FDA responses, new / changed product 510(k)s, process / product / equipment including QMS and software validations, ISO 14971 product risk management files / reports, design control / design history files, and technical files. He's held positions in manufacturing engineering, QA, QAE, regulatory affairs, to the level of director and VP (R&D). In addition, Mr. Lincoln has prior experience in military, government, electronics, and aerospace. He has published numerous articles in peer reviewed journals, conducted workshops and webinars worldwide on CAPA, 510(k)s, risk analysis / management, FDA / GMP audits, validation, root cause analysis, and others. Mr. Lincoln is a graduate of UCLA.

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