Why Should You Attend:
Purchasing Controls has always been an integral part of the Medical Device Regulations (21 FCR Part 820 Section 820.50). It calls for medical device manufacturers to "ensure that all purchased or otherwise received product and services conform to specified requirements". However due to the recent incidents of contaminated heparin, peanut butter, and pre-filled syringes, melamine in milk, lead in toys and diethylene glycol in toothpaste, more emphasis is going to be placed on medical device manufacturers to have stricter controls over their suppliers. Moreover, warning letters with respect to supplier controls have increased over the last 3 years. A recent GHTF guidance document ( http://www.ghtf.org/documents/sg3/sg3final-N17.pdf ) describes the process and requirements. The new emphasis on supplier controls by the FDA is based on this guidance document.
It is the responsibility of the medical device manufacturers to provide the detailed requirements and specifications to their suppliers and exert the appropriate levels of controls (in terms of product quality, no change agreements, supplier audits, material tests and requirements etc.). The level of controls will depend upon the risk of the device and hence the criticality and risk of the components and parts that go into those devices.
This Webinar will discuss the importance of purchasing controls. What are the levels of controls that need to be exerted based on device and product risk and classification. The participant will also understand the elements of the supplier control process and develop and maintain appropriate procedures to control suppliers, materials and services.
Areas Covered in the Seminar:
Who Will Benefit:This Webinar is designed for people involved in the specifications and purchase of raw materials, components and services. This typically includes:
Dr. Vinny Sastri, Ph.D., is the President of WINOVIA® LLC and has over 25 years experience in new product development and quality management with a strong track record in the healthcare, medical device, electronics, plastics and the automotive industries. He is a certified Six Sigma black belt. WINOVIA assists companies increase their growth and profitability via customized solutions, strategies, training and implementation of effective, self-sustaining new product development and quality management processes. Areas of expertise include quality systems, product design and development, design controls, manufacturing and process validation, FDA and ISO quality systems for medical devices and pharmaceuticals, risk management, CAPA and materials.
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. ComplianceOnline 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.If you have any concern about the content of the webinar and not satisfied please contact us at below email or by call mentioning your feedback for resolution of the matter. We respect feedback/opinions of our customers which enables us to improve our products and services. To contact us please email [email protected] call +1-888-717-2436 (Toll Free).
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