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This webinar will guide you on how to develop, use and document Raw Materials Risk Management based on a Product Hazard Analysis and the Product Risk Management File and Report per ISO 14971 and ICH Q9.
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, and satisfy U.S. FDA cGMP and CE-marking / Notified Body expectations. 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 for Devices (with ALARP discussion)
ICH Q9 for Pharma
Product Hazard Analysis
Fault Tree Analysis
Design, Process, and Use[r] Failure Mode, Effects and Criticality Analysis
Suggested Risk Management File / Report, FMECA, FTA Templates
Driving Product Risk Management down to RM and Component Levels
Why and How to use the ISO 14971 "Model" in all Regulated Industries
The Team and Its Involvement ? Who, When and How
Using the Completed Document ? It?s Real Value ?In the Loop?
Who Will Benefit:
This webinar will provide valuable assistance to all U. S. FDA-regulated companies. It will assist in their developing / reviewing / modifying their product design / formulations, manufacturing processes, and use environment in light of product risk to the end user. Also in addressing their regulatory compliance stance in view of the areas the FDA indicates are of growing / future interest / emphasis. Its principles apply to personnel / companies in the Medical Devices, Pharmaceutical, Diagnostic, Biologics and Combination products fields. The employees who will benefit include:
Research and Development
QA / RA
All personnel involved in verification and/or validation planning, execution and documentation.
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