Amy M. Peterson

Speaker Profile :

Amy M. Peterson, MS has 18 years of quality assurance (QA) experience in the biotechnology / pharmaceutical industry. Her most recent years have been focused on bringing an understanding of how to take quality to the next level of robustness. She has extensive expertise: - MANAGING HUMAN ERROR - Designing robust QA systems, including the ehancement of a systems to MEASURE EFFECTIVE CORRECTIVE ACTION/PREVENTIVE ACTION (CAPA) - Designing quality systems which account for human system interaction, preventing human error from leading to a deviation (i.e., event, excursion, exception) that carries consequences. She adapted, implemented and evaluated an engineering and psychology based approach to managing human error in the industry with parallel success to the North America commerical nuclear industry where the approach was developed by academics and industry experts; now proven successful for over 20+ years. RESULTS ACHIEVED:  > $100,000 MILLIONs saved in just one facility (approximately 1200 employees)  Multiple company awards  > 80% REDUCTION in deviation rates (deviations per batch) Trained/mentored by a collegeage with 25+ years of experience working in North Americal commercial nuclear. MENTOR is a: - Senior Reactor Operator (SRO) - Nuclear Regulatory Commission (NRC) Certified expert in Human Error Management This specialized expertise with it’s application to CAPA effectiveness has tremendous benefits for all high risk industiries to provide error free services. Amy’s background also includes: - Evaluating and creating new quality systems - Product and system data analyses - Consent Decree remediation - Product recall management, 483 responses - Designing and implementing training systems - Technical writiting for controlled, instructional documents

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