Acceptance Activities under the FDA's QSRs
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Instructor Profile Dawn Haake is the Senior Director of Global Quality Assurance for a leading developer of spinal orthopaedic surgical solutions in Southern California. With over 25 years of experience working within the quality field in organizations such as Infrasonic, Nellcor Puritan Bennett, Mallinckrodt and Covidien (formerly Tyco Healthcare), Ms. Haake has had extensive input into the creation, maintenance and regulatory presentation of Quality Management Systems designed to address a broad range of device applications and classifications, from complex Class II and III microprocessor controlled life support systems to high volume sterile disposables such as surgical kits and suture devices.
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Description This webinar will explain the FDA QSR requirements for acceptance activities related to medical device manufacturing. It clarifies FDA’s intent using the preamble to the regulations. We will analyze recent Warning Letters and provide tips to ensure that your acceptance activities fully complies with the regulatory requirements.
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Why should Attend This webinar will provide Acceptance activities are common in device manufacturing, but seem to cause problems for some manufacturers. These problems range from simple instances of lack of procedures or acceptance criteria to misapplication of statistical methods.
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Objectives Understand the regulatory requirements for acceptance activities. Explain the relationship between supplier selection and receiving acceptance. Know the required documentation when the supplier performs the inspection and tests. State the FDA expectation for quantitative data in acceptance activity records. Explain the use of sampling plans and describe the OC curve. State the FDA expectation on using components before completing acceptance activities. Understand the record keeping requirements for acceptance activities. State the requirements to release a device for distribution, including the DMR linkage.
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Who Can Benefit Quality Managers Quality Professionals Production Managers Production Supervisors Manufacturing Engineers Production Engineers Design Engineers Process Owners Purchasing Professionals Inspection and test Managers
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How this Webinar Works Username and Password will be sent to you 24 hours prior to the webinar Presentation handouts in pdf format will be mailed to you Login to the session using the username and password provided to you Get answer to your queries through interactive Q&A sessions via chat
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