New England AGXPE Presents "Quality Intelligence - Regulatory Considerations for Advanced Data Analytics

Quality Intelligence - Regulatory Considerations for Advanced Data Analytics

As FDA pushes industry to demonstrate "vigilant monitoring of inter- and intra-batch variability" in response to increasing number of drug shortages & safety recalls, one solution has been the development of Quality Intelligence Dashboards, which are designed to evaluate existing data sets in new, user-friendly formats to prevent quality related delays in our critical pharmaceutical supply chain.  In this discussion we will provide some examples of simple software solutions, followed by the potential regulatory expectations and requirements for use of such data solutions in a regulated GXP environment.

BIO:

Peter E. Baker, President, Live Oak Quality Assurance LLC, has been consulting nationally and internationally since April 2019.  Prior to consulting, Peter spent 11 years as a U.S. FDA Drug Investigator, with 7 of those years spent working in FDA’s overseas offices located in India, China and Chile.  Peter was named FDA Investigator of the Year in 2013 for his work uncovering serious breaches in data integrity and has special interest in big data management and compliance with 21 CFR Part 11. Live Oak focuses on training and employee empowerment in critical thinking, with the goal of improving the quality of medicines through good data management. 

Peter holds a Bachelor of Science (B.S) degree in Biology-Chemistry from Point Loma Nazarene University, a Master’s of Science (M.S.) in Chemistry from San Francisco State University, and is an active member of PDA and ISPE. 

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