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Develop a Product Risk Management File (ISO 14971, always required), and a Human Factors / Use Engineering File (IEC 62366-1, as required)
- The Revised ISO 14971:2019 for Devices; key changes from :2007/9/12 versions
- ICH Q9 for Pharma
- IEC 62366-1 and -2 Use Engineering, Human Factors "Process" Requirements
- Product Hazard Analysis
- Design Process and Use[r]-Failure Mode, Effects and Criticality Analysis
- Fault Tree Analysis
- Suggested Risk Management File / Review, FMECA, FTA Templates
- Suggested Use Engineering IEC 62366-1 9-Stage Process Templates
- Use Engineering and the device "Interface"
- What and When Required
Overview of the webinar
Expectations for meaningful hazard analysis, hazardous conditions, and 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 (always required) and Human Factors / Use Engineering (not always required) are the tools to drive and direct resource constrained product design, manufacture and validation activities in the company. To this has bee added the requirements to add risk management to important QMS activities as spelled out in the 2019 version of ISO 14971 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 / human factors tools. Effective use of such 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. Two suggested Field-tested and Agency / EU audited "model" formats will be presented, suitable to meet both US FDA CGMP and EU regulatory requirements.
Who should attend?
- Senior management in Drugs, Devices, Biologics, Dietary Supplements
- QA
- RA
- R&D
- Engineering
- Production
- Operations
- Consultants; others tasked with project leadership responsibilities
Why should you attend?
How to develop, modify and use hazard analysis and the Product Risk Management File and Report per ISO 14971:2019 and ICH Q9
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 potential "use errors", and take reasonable steps to mitigate them as far as practical and given the ‘state of the art’ at the time. ISO 14971, ICH Q9 (risk) and IEC 62366 (use / human factors) 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 procedures, provide and discuss suggested templates, necessary to develop or modify and then use the ISO 14971, Q9, and IEC 62366 models to perform and document such activities for any medical product. It will examine the additional actions necessary to make them useful product references, CAPA, root cause / failure investigation, and validation prioritization, and training tool, and how to maintain it as a “living document”. The latest change in ISO 14971:2019 will also be considered and discussed, including it's expansion to include a company's entire QMS.
Faculty - Mr.John E. Lincoln
John E. Lincoln, is Principal of J. E. Lincoln and Associates LLC, a consulting company with over 40 years experience in U.S. FDA-regulated industries, 27 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 including 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 ptublished 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.