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 products. 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. A suggested Field-tested and audited "model" format will be presented.

Areas Covered:-

• 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 Management File / Review, FMECA, FTA  Templates
• The Team and Its Involvement – Who, When, and How
• Using the Completed Document – It’s Real V,alue “In the Loop”

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 are 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, 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 its expansion to include a company`s entire QMS.

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