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DTSTART:20200708T150000Z
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SUMMARY:Process and Test Method Validation, using variation and sampling to set acceptance criteria
DESCRIPTION:This webinar will describe using variance components and risk based statistical sampling plans to set acceptance criteria for test method and process validations.\nWebinar Outline:\n\nWhy validate\n\nBrief review of what validation means\nBrief review of regulations and guidance around validation\n\n\nThe concept of acceptance criteria\n\nWhat is it?\nWhy do you need it?\n\n\nSetting acceptance criteria for Test Method Validation\n\nConcept of process capability\nUsing capability to set acceptance criteria\n\n\nSetting acceptance criteria for Process Validation\n\nThe concept of acceptance sampling\nAcceptance sampling for process validation\n\nRisk based acceptance sampling\n\n\n\n\nUsing acceptance sampling to set acceptance criteria\n\n\nSpeaker:\nAlan Golden, MS, Principal, Design Quality Consultants, LLC\nAlan has over 30 years of experience in the medical device industry, both in basic research and in quality assurance. Alan spent 31 years at Abbott Laboratories. For the first 16 years as part of diagnostics R&D, he developed recombinant proteins used in diagnostics tests, received three US patents and published numerous papers and abstracts. Alan then transitioned to a quality assurance role where in both the Abbott Diagnostics and Abbott Molecular divisions, he was responsible for quality assurance for new product development, on-market product support and operations.\nAlan’s quality assurance experience extends from design control, change control, risk management, CAPA, process and test method validation and statistics. He has been lecturing on these topics worldwide for over 10 years.\nAlan retired from Abbott in 2018 and now runs Design Quality Consultants, providing training, workshops and seminars in many areas of quality assurance.\nAlan received his BS degree in Microbiology from the University of Michigan and his MS degree in Molecular Biology and Immunochemistry from the University of Illinois.\n\nWhy you should attend the session:\nSetting appropriate acceptance criteria for validation is critical to assure that the test method and process meets the needs of the product and end user.\nWho Will Benefit from this Webinar:\nThis seminar would be appropriate for Pharma, Biotech, and Medical Devices\nWho Should Attend:\nThis webinar is for professionals in the Pharma, Biotech, and Medical Devices industries with responsibilities in the following areas:\n\nQuality Systems\nQuality Assurance\nQuality Control\nEngineering\nValidation\n\n\nRegistration Information:\nThe registration fees for IPA webinars/online events are per person basis, whether delegates are attending together from a conference room or from separate locations.\n\n1 Attendee:  $208 + HST CAD per session\n2 Attendee: $356 + HST CAD per session\n3 Attendee: $488 + HST CAD per session\n4 Attendee: $589 + HST CAD per session\n5 Attendee: $658 + HST CAD per session\nTo register for a Group of 6 or more, please contact us at enquiry@ipacanada.com \nRegister Today!\n\nLog in information will be provided 24-48 hours prior to the webinar.\nAll participants will receive an e-Certificate of training 2 weeks after the live presentation.\n
URL:https://ipacanada.com/events/process_test_method_validation/
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CATEGORIES:Live Webinar
LOCATION:Online Training
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