From July 23 to August 1, registrations for this course must be completed via form submission while we upgrade our registration system. Please direct any questions to firstname.lastname@example.org. Thank you for your patience while we work to improve your online experience.
This 2.5-day course provides attendees with practical tools and techniques for process validation requirements for FDA’s Quality System Regulation and recognized process validation guidance from the Global Harmonization Task Force. The program includes industry best practices and real-life process validation examples. Topics include planning, protocol development, validation execution, monitoring & control and re-validation to meet the FDA’s expectations and the industry’s best practices.
Virtual Training Information
Our virtual training environment allows you to have direct interaction with your instructors and your fellow attendees. AAMI uses Zoom for virtual classes. You can test your connectivity and ability to use Zoom at zoom.us/test.
For virtual training courses, we request that you register at least one week in advance of the course start date to allow sufficient time for shipping of training materials and devices (Please allow two weeks for non-U.S. addresses). If you register within these time frames, AAMI cannot guarantee you will receive material prior to the start of the course but you will have access to digital versions of the materials. If you have any questions, please email email@example.com.
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President, Momentum Solutions, LLC
Andrew has over 25 years of experience managing quality, operations, design and development for large medical device companies, start-ups and as a contract manufacturer. He has proven expertise in quality systems, risk management, design controls, process validation, quality and reliability engineering. He has leveraged this expertise to help companies improve compliance, product quality and financial performance. He has a BS degree in Biology from Fort Lewis College, a Masters degree in Engineering from Northwestern and a graduate certificate in Systems Engineering from Arizona University.Andy is an ASQ member and a member of the International Council of Systems Engineering. He was an instructor in Statistics, and Quality and Productivity management at the University of Phoenix. He has published articles on Risk Management, Design Control and Process Validation. He is a frequent presenter in Risk Management, Design Controls and Supplier Quality at Medical Device Manufacturing conferences.