Year after year, one of the top reasons cited by the FDA in 483s is “lack of or inadequate procedures” for CAPA. This course will give you the knowledge you need to eliminate warnings due to CAPA-related issues.
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-US 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.
”Having insightful faculty who have seen a variety of industry practice was very valuable. Additionally, I thought including the linkages to other quality systems, specifically management review, was a nice addition to just talking about the actual CAPA process. It is really a benefit in the FDA attending the course as well as providing some of the training.”
– Recent Course Attendee
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Lead: Art Ward
Art Ward, Ph.D., MBA, BSEE is the Founder of AJW Technology Consultants, Inc. His firm provides global regulatory, quality systems and technical support for medical manufacturing and development companies. Mr. Ward began his career as an engineer for a major medical optics firm. He then progressed into manufacturing and quality, becoming a Plant and Division Manager for a blood systems manufacturing company. Prior to starting his own consulting firm, Mr. Ward was Vice President of RA/QA for an anesthesia and respiratory products company. He has design control and validation experience with many medical products including software controlled devices. With 40 years of expertise in the medical field, his experience with quality systems has aided many firms achieve ISO 13485 Certification and FDA Compliance.