Event Summary
Development of a Voluntary Quality Assurance (VQA)® Culture
A good quality culture is often described as one that puts the interest and safety of patients and consumers above all else and where people do what is right vs. what is good enough. To achieve this we must develop a simplified approach, so companies efficiently obtain a state of compliance and remain that way. We must begin to approach the quality question as a scientist would – with the same rigor and discipline found at the bench. It is important to break it down into its basic principles, so it can be accessible for general consumption and integrated into your company’s core values. This presentation describes the elements of a VQA® Culture and the tools to use to achieve a VQA® Culture.
Speaker Biography
Judy Carmody, Ph.D., is the founder and Principal Consultant of Carmody Quality Solutions, LLC. Dr. Carmody has 25+ years of specific expertise driving vision in operations, Quality assurance, control, systems, validation, and analytical development. She has held Quality leadership positions at several pharma/biopharma companies and built Quality management systems for both start-up and Fortune 500 companies. She is the former founder and president of Avatar Pharmaceutical Services, an FDA-registered contract research organization and registered manufacturer which was acquired by Vertex Pharmaceuticals in 2010.
Prior to founding Avatar, Dr. Carmody spent 10 years in the (bio)pharmaceutical industry, developing methods for small molecules and oligonucleotides, managing QC, Analytical, and Validation groups.
Dr. Carmody holds a Bachelor of Science degree in Chemistry from Worcester State University, and a Master of Science degree and a Ph.D. in Analytical Chemistry from Clark University in Worcester, Massachusetts.
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