Amy M. Peterson, MS is a quality leader with 22 years of experience, designing, enhancing, remediating, implementing and managing award-winning robust, risk-based Food and Drug Administration (FDA) compliant quality systems in pharmaceutical, biotechnology, and medical device industries.
She is dedicated to relentlessly influencing and educating industry leaders and regulators on understanding how to raise quality standards to ensure consumers receive quality products.
Experienced at integrating proven techniques and tools from different industries into quality systems to achieve tremendous continuous improvement results; multi-billion dollar cost savings:
- Implementing effective corrective action(s) and preventive action(s) (CAPA)
- Increasing process efficiencies by >26%
- Decreasing deviation rates by >86%
- Deploying concepts, tools and techniques to manage human error, which have been proven successful for 20+ years in North America Commercial Nuclear
- Human factoring controlled documents and processes
- Training and implementing proven methodology to achieve procedural (SOP) adherence
- Bachelors in Chemistry from North Carolina State University (NCSU)
- Masters in Human Nutrition from East Carolina University (ECU)
- CURRENTLY earning Masters in Regulatory Science from Johns Hopkins University (JHU) [2016 to 2018]
Masters in Regulatory Science
The MS in Regulatory Science from Johns Hopkins University (JHU); curriculum developed through collaboration with the Food and Drug Administration (FDA) and includes lectures by both esteemed JHU professors and FDA staff.
Additionally, she is embarking on a personal and professional journey, authoring a book:
"I Have What?" A True Story of Being Diagnosed with a Rare Disease
In memory of my late and dearest best friend, whose wish was for her experience to be shared with others to raise awareness about how and where to get help when diagnosed with a rare disease.