Overview
How to develop, modify and use hazard analysis and the Product Risk Management File and Report and in the QMS per ISO 14971:2019 and ICH Q9
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 is a required tool to drive and direct resource constrained product design, manufacture and validation activities in the company. High-profile field problems indicate that such activities are not yet adequately planned, executed, and visibility maintained by many companies. This points to 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. A suggested Field-tested and FDA- and Notified Body-audited "model" format will also be presented.
Why Should You Attend
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 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. 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 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, 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 .
Webinar Takeaway
- The Revised ISO 14971:2019 for Devices; key changes from - :2007/9
- ICH Q9 for Pharma
- Product Hazard Analysis
- Design, Process, and Use[r] Failure Mode, Effects and Criticality Analysis
- Fault Tree Analysis
- Suggested Risk Managment File / Review, FMECA, FTA Templates
- Residual Risk; Benefit / Risk Analysis
- The Team and It’s Involvement – Who, When and How
- Using the Completed Document – It’s Additional Real Value “In the Loop”
Who Will Benefit
- Senior management in Drugs, Devices, Biologics, Dietary Supplements
- QA
- RA
- R&D
- Engineering
- Production
- Operations
- Consultants; others tasked with project leadership responsibilities
Faculty John E. Lincoln
Principal of J. E. Lincoln and Associates LLC
John E. Lincoln is an internationally recognized FDA regulatory compliance, medical device quality systems, and validation expert with more than 40 years of experience in the life sciences industry. He specializes in FDA QMSR, ISO 13485, Design Controls, Software Validation, Process Validation, Risk Management (ISO 14971), 21 CFR Part 11, Data Integrity, and Medical Device Cybersecurity. John has trained thousands of professionals worldwide and is a respected author and conference speaker, helping pharmaceutical, biotechnology, and medical device organizations achieve regulatory compliance, improve product quality, and prepare for successful FDA inspections.
