This webinar will discuss setting up statistically justified sampling plans for process validation. Discussion will also involve using the sampling plan to set acceptance criteria for process validation. Setting acceptance criteria for test method validation will also be presented.
All companies in the pharmaceutical and medical device space are required to implement formal and statistically justified sampling plans and acceptance criteria for validation. Many companies do not have dedicated statistics departments, so it is up to the validation or quality engineer to develop sampling plans. This training will a simple step by step method of developing statistically justified sampling plans and acceptance criteria.
This webinar will discuss methods for setting up sampling plans depending on the risk profile of the final product or production step. It will go into using the sampling plan to set statistically justified acceptance criteria for the validation. Also presented will be setting confidence levels and spreading that confidence level out over multiple runs. Setting statistically justified acceptance criteria for test method validation will also be discussed.Areas Covered in the Webinar:
from Medical Device and Pharmaceutical Companies
Principal, Design Quality Consultants
Alan 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. Alan’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. Alan retired from Abbott in 2018 and now runs Design Quality Consultants, providing training, workshops and seminars in many areas of quality assurance. Alan 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.
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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