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 (:2007) or as far as possible (:2012), given the ‘state of the art’ at the time. ISO 14971 (Devices) and ICH Q9 (Pharma) provide accepted methodologies by which to perform and document such an analysis and is accepted by the FDA. The newly revised Usability Engineering standard, IEC 62366-1, -2, references ISO 14971. These steps are required in Design Control (21 CFR 820.30) and Design and Development Planning (ISO 13485, 7.3). Their principles can be adopted (and have) to all regulated medical products. Both allow for a degree of options. These tools also help assess the degree of risk that 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 with expert speaker John E. Lincoln 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. He 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”. John will present an overview of the basic activities and documents to show compliance to this standard, in its two current versions, as expected by both the U.S. FDA, and European Union (and related) Notified Bodies. He will also examine the business advantages of these tools.
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.
This webinar will answer basic questions device manufacturers, start-ups, investors and other stakeholders have as to the basic medical device and pharmaceutical and other development process incorporating product Risk Management analysis, actions and their documentation in a Risk Management File and Report, for use in a CGMP environment, in the U.S., and EU / worldwide. You will be provided all suggested sample templates.
Who Should Attend?
Ask a question at the Q&A session following the live event and get advice unique to your situation, directly from our expert speaker.
- Casper E. Uldriks
John E. Lincoln is the Principal of J. E. Lincoln and Associates LLC, a consulting company; with over 35 years of experience in U.S. FDA-regulated industries, 21 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...
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