This webinar about risk-based design control reviews the FDA’s and ISO’s guidance and regulations and provides practical ways to implement a robust risk-based design control in your company. It shows you practical ways to simply work and hand and enough spend time on actual risk management and mitigation.
Creating, managing, and maintaining all the information found in the various Risk Management documents and files isn’t easy because all of them are often redundant, repetitive, and clustered together in an award way. This webinar will provide you a totally different viewpoint and a very different approach that you can employ.
As a manager, you will learn new ways to make sure that your design and manufacturing staff do not spend too much time on documentation but instead send enough time on actual risk management and mitigation.Areas Covered in the Webinar:
Managers, Supervisors, Directors, and Vice-Presidents in the areas of:
From Medical device and combination product biotechnology devices
Principal Consultant, Atzari Enterprises
Jose Mora is a Principal Consultant specializing in Manufacturing Engineering and Quality Systems. For over 30 years he has worked in the medical device and life sciences industry specializing in manufacturing, process development, tooling, and quality systems.
Prior to working full time as a consulting partner for Atzari Consulting, José served as Director of Manufacturing Engineering at Boston Scientific and as Quality Systems Manager at Stryker Orthopedics, where he introduced process performance, problem solving, and quality system methodologies. During that time he prepared a white paper on the application of lean manufacturing methods to the creation and management of controlled documents and a template for strategic deployment.
Jose led the launch of manufacturing at a start-up urology products company as Director of Manufacturing for UroSurge, Inc. at the University of Iowa’s business incubator park in Coralville, IA, creating a world-class medical device manufacturing operation, with JIT, kanban systems, visual workplace and lean manufacturing practices.
Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance. FDATrainingAlert would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange.
Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time.
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