Speaker: Dr. Pauline L. McGregor

Seminar will be conducted online via Zoom @ 5:30 pm EDT

Abstract

Medicinal products are released to patients based on decisions that claim they are of the required  identity, purity, quality, safety and efficacy for the intended use. These decisions are supported by the generation, documentation and review of any data associated with the product, including the source of materials, the manufacturing process and methods of testing. Data governance, good data/ record management practices and ensuring the integrity of the data are therefore critical components of a company’s quality system.   

This presentation provides an overview of regulatory expectations in a GMP environment for data management programs and presents an insight into data integrity, data governance, and good documentation practices for paper and electronic data. Although the focus is on a GMP environment, the data practices discussed, are also relevant and can be applied across the product lifecycle.

About Speaker

Pauline holds a PhD in organic, analytical chemistry and has fulfilled a variety of roles in over thirty years in the pharmaceutical industry.  She founded PMcG Consulting in September 2006. 

She is an expert in quality systems and procedures, GMP regulations and analytical chemistry.  

She brings a technical expertise to laboratories and manufacturers which enable her to assist them to develop, transfer, verify and validate analytical procedures and manufacturing processes, and also optimize efficiency with regards to operations and troubleshooting both in development and GMP environments. Pauline also has the experience and ability to customize and install the quality systems required to allow new manufacturing and testing companies to operate to GMP regulations and review and improve on current quality systems to allow more efficient operations. 

She is a renowned trainer in her areas of expertise, a valuable consultant, and a detailed oriented auditor. She has utilized her skill set globally in the UK, Canada, US, Jordan, Brazil, and China and has helped companies prepare for a GMP inspection to gain their European/Health Canada/FDA GMP licenses. 

Pauline has been involved in the development and evolution of lifecycle management for analytical procedures since 2010. She  was a member of the USP expert panel for Validation, Verification and Transfer of Analytical Procedures and a member of a USP Chemical Medicines expert review committee. She continues to be a USP volunteer Expert Advisor and is a Member of the Royal Society of Chemistry , UK.