Hazard Analysis and Product Risk Management under ISO 14971 and ICH Q9

The U.S. FDA has stated that the use of a medical device or pharmaceutical 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” / possible, given the ‘state of the art’ at the time. 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. High-profile 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.

ISO 14971 and ICH Q9 provide accepted methodologies by which to perform and document such an analysis and is accepted by the FDA. The degree of risk can be a determinant on the level of failure investigation, validation effort, et al, required of those activities. The resulting documentation can also be used as a method to train new hires, especially in Marketing, QA/RA, Engineering, and Manufacturing.

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, and satisfy U.S. FDA cGMP and CE-marking / Notified Body expectations. It will examine the additional actions necessary to make it a useful product reference, CAPA, root cause / failure investigation, and validation prioritization, and training tool, and how to maintain it as a “living document”.

Areas Covered in the Session :
The Revised ISO 14971 for Devices (with ALARP discussion)
ICH Q9 for Pharma
Product Hazard Analysis
Fault Tree Analysis
Design, Process, and Use[r] Failure Mode, Effects and Criticality Analysis
Suggested Risk Management File / Report, FMECA, FTA Templates
Why and How to use the ISO 14971 “Model” in all Regulated Industries
The Team and It’s Involvement – Who, When and How
Using the Completed Document – It’s Real Value “In the Loop”
Q & A session

Who Will Benefit:
This webinar will provide valuable assistance to all U. S. FDA-regulated companies. It will assist in their developing / reviewing / modifying their product design / formulations, manufacturing processes, and use environment in light of product risk to the end user. Also in addressing their regulatory compliance stance in view of the areas the FDA indicates are of growing / future interest / emphasis. Its principles apply to personnel / companies in the Medical Devices, Pharmaceutical, Diagnostic, Biologics and Combination products fields. The employees who will benefit include:
Senior management
Middle management
cGMP instructors

John E. Lincoln

John E. Lincoln, is Principal of J. E. Lincoln and Associates LLC, a consulting company with over 36 years experience in U.S. FDA-regulated industries, 22 of which are as an independent consultant. John 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 QMS and software validations, ISO 14971 product risk management files / reports, Design Control / Design History Files, Technical Files, CAPA systems and analysis.

He’s held positions in Manufacturing Engineering, QA, QAE, Regulatory Affairs, to the level of Director and VP (R&D). In addition, John 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. He writes a recurring column for the Journal of Validation Technology. John is a graduate of UCLA.

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