The FDA 21 CFR Parts 820 Quality Systems Regulations requires that quality is designed into the product to ensure the production of safe and effective devices for the intended use.
Thus it is important to identify the critical parameters that will affect the key properties of a finished device. Once these critical parameters or components have been identified, they should be controlled all the way from receiving, during manufacturing and assembly, and, in the finished device. Identifying the critical components should occur during product design (Design Controls). Component quality and consistency should be tested and evaluated from the suppliers (Purchasing Controls) and during production (Production and Process controls). This Webinar will highlight importance and methods of identifying critical parameters during design and controlling them during production to ensure the safety and efficacy of the device.
Areas Covered in the seminar:
Who Will Benefit:
This webinar will be of value to those who want to understand how to identify and control the critical parameters that affect the safety and efficay of a device. Functions that will benefit from this webinar include:
Dr. Vinny Sastri, President of WINOVIA® LLC, and has over 20 years experience in new product development and quality improvement with a strong track record in the healthcare, medical device, electronics and consumer goods industries. He is a certified Six Sigma blackbelt. Winovia LLC a consulting company that provides sustainable solutions new product development, quality improvement and high performance materials with the goal of strategic market penetration, improving efficiencies of products, processes and services, streamlining business processes, reducing operational costs, improving margins and increasing revenues and profits for its clients.
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