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10 Steps to Effectual Risk Analysis for US FDA and ISO 14971 Compliance
- The Revised ISO 14971:2007 vs: 2012 for Devices
- ICH Q9 for Drugs
- Product Hazard Analysis
- Design, Process and Use[r] Failure Mode, Effects and Criticality Analysis
- Suggested Risk Management File / Report,Narrative, FTA, 3- FMECAs, 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
Overview of the webinar
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 a 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. ALARP 2007 vs ALARP 2012. 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. It also provides the true foundation for a company’s Risk-Based approaches in all CGMP areas.
Who should attend?
- Senior Management
- Middle Management
- QA/RA
- CGMP Compliance Auditors
- Consultants
- Operations
- Production
- Engineering
- Marketing
Why should you attend?
The U.S. FDA has repeatedly 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 for identifying those risks and taking 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, although triggering heated arguments on Internet forums. What changes are necessary to better address patient hazards / risks? How to adapt to a “risk-based” activity? The degree of risk can be a determinant of 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. It will examine the additional actions necessary to make it a useful product reference, CAPA, root cause / failure investigation, validation prioritization, training tool and how to maintain it as a “living document”.
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.