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Nice response to my questions and good suggestions for moving forward.

Some of these sessions are too basic - this one had a good mix of basic and details. The tips are helpful. One comment: a little more discussion regarding the use of Detection in FMEAs would be useful since many do not advocate its use. Thanks,

I especially liked that the Q&A session after the webinar was long enough to not only address my own questions but also to learn from the questions from the other participants in the webinar.

Very thorough understanding of the history/progression of the guidances, and very helpful evaluation of current and potential directions. Excellent presentation skills, very engaging.


 Speaker Profile


Vincent M. Dailey
Executive Vice President, Quality Assurance Systems, Inc.

Mr. Dailey is current serving as the Executive Vice President of Quality Assurance Systems, Inc. (QAS), a GXP consulting and professional research services firm based in Bonsall, CA, USA. QAS service areas include Quality Systems Development, Quality Assurance, Inspection Readiness Assessments, training, retrospective data review & collection and expert testimony. Since joining the firm in 2000, Mr. Dailey has served more than 40 biomedical and medical device companies in over 25 countries worldwide in the product areas of drugs, biologics, vaccines, antibiotics, and ophthalmics and product development stages of pre clinical through post marketing. Mr. Dailey and has performed technical service provider, laboratory, investigational site, sponsor-monitor, database, clinical report, submission, process, computer systems and validation audits, and general consulting in the US and internationally. Before joining QAS, Mr. Dailey served as a GCP Compliance Specialist for Innovative Clinical Solutions, Inc. and as a CRA for Quintiles. He received a BA in psychology from the University of Toledo and his Master’s degree in neuroscience from the Medical College of Ohio.

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