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Joe W. Simon
Growing up in International Falls, Minnesota (“the icebox of the nation”), Joe started his studies at St. Olaf College but transferred to Bemidji State University where he earned his bachelor of sc...показать большеGrowing up in International Falls, Minnesota (“the icebox of the nation”), Joe started his studies at St. Olaf College but transferred to Bemidji State University where he earned his bachelor of science degree in chemistry (with honors). He later earned a master of business administration (MBA) degree through Jones International University. He has been a member of the American Society of Quality (ASQ) since 2008.
Starting out as a bench chemist performing environmental and nutritional labeling testing, Joe rewrote almost every analytical method he touched and developed a few new ones. It was during this time that he learned the importance of accuracy, linearity, range, and (especially) system suitability (for example, reagent blanks, matrix blanks, duplicate samples, blank-spikes, matrix spikes, check samples, etc.) for a test method. He also performed minimum detectable limit (MDL) studies for a battery of herbicides and pesticides. This also introduced him to the concepts of good laboratory practice (GLP) and FDA requirements.
He eventually transitioned into pharmaceutical quality assurance and quality control. Working for five years at a pharmaceutical company that was under the FDA’s Application Integrity Policy (AIP), he learned the importance of being transparent with your quality problems and your processes. During his time in pharma, he became familiar with AQL sampling tables and started developing quality trending and metrics.
In 2005, Joe started consulting, and his first project was helping a large, multinational medical device manufacturer build process FMEAs for all its products. In the intervening years, he worked with numerous companies to build or improve their complaint analysis, trending, postmarket surveillance (PMS), nonconformance (NC), corrective action/preventive action (CAPA), stewardship, and risk management processes.
With more than 25 years of experience, Joe recently retired from consulting. As a manager, he was responsible for direct management of the consulting personnel as well as ensuring the competency, quality, experience, project management, and service excellence of the engagement teams. He helped many companies by teaching them how to be more compliant and efficient. Now that he’s retired, he gets to enjoy spending more time with his family.показать меньше
Книги автора Joe W. Simon
Risk Management for Medical Device Manufacturers: [MD and IVD]