Amy M. Peterson, MS has 19 years of quality assurance (QA) experience in the biotechnology, pharmaceutical and medical device industries.

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:

• HUMAN ERROR : Managing human error during system interaction.
• CAPA: Designing robust QA systems, including the enhancement of a systems to measure EFFECTIVE CORRECTIVE ACTION/PREVENTIVE ACTION (CAPA)
• ROBUST QUALITY SYSTEMS: 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 commercial 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)

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 writing for controlled, instructional documents