Customer Testimonials
|
|
Subscribe NewsletterProduct Risk Management Under ISO 14971 and FDA-ICH Q9
Product Id
:
600620
Overview: 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. 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.
Why you should 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”.
Areas Covered in the Session:
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. 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.
Why you should 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”.
Areas Covered in the Session:
- The Revised ISO 14971:2007/9 for Devices
- ICH Q9 for Pharma
- Product Hazard Analysis
- Design, Process, and Use[r] Failure Mode, Effects and Criticality Analysis
- Fault Tree Analysis
- Suggested Risk Management File / Report, FMECA, FTA Templates
- The Team and It's Involvement – Who, When and How
- Using the Completed Document – It's Real Value "In the Loop"
- Senior Management in Drugs, Devices, Biologics, Dietary Supplements
- QA
- RA
- R&D
- Engineering
- Production
- Operations
- Consultants; others tasked with project leadership responsibilities