Description

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 been 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. Additional assistance in developing UE/HF tests can be provided by HEP tools.

Areas Covered in the Session:-

• ISO 14971:2019 for Devices; and 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 Elements
• Use Engineering and the device "Interface."
• What and When Required
• What is HEP; common HEP tools, and possible Use Eng'g tests from HEP.

Background:-

How to develop, modify, and use the tools of the User/Patient Device Risk Management File per ISO 14971:2019 (a major requirement of the new QMSR), Pharma's ICH Q9, and Error Reduction with IEC 62366-1, Usability Engineering, with added HEP considerations.

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 for identifying those risks, and potential "use errors", and taking 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 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, 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, 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. How HEP can assist, especially in developing Useability tests. 

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