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 wherein 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.
March 05 2024
12 : 00 PM EST
This workshop will explore the topic of setting appropriate sampling plans and using those plans to set appropriate acceptance criteria for process validations. Using a 5 step method, the attendee will come away with a good understanding of sampling for validation including using risk to make sampling decisions. It will also explore using variance to set acceptance criteria for test method validation. Lastl..
In this program, we will discuss the common statistics tools and techniques used in validation. Through real world examples and interactive exercises, we will demonstrate the basic concepts of statistics and how to apply them to your validation projects. Discussion will center around measures of variance, sample distributions, and expressions of variance. The session will conclude with a discussion of the c..
This session will be highly interactive with audience members actively participating in an open discussion of their audit experience. Through discussion and examples, participants will gain an understanding of how to prepare for an audit, strategies to conduct and support a successful audit, and ways to respond to audit observations. Special consideration will be given to virtual audits as a result of the C..