Pauline McGregor • Ph.D.
Pauline McGregor Ph.D. CChem MRSC founded PMcG Consulting in September 2006. She has over thirty years’ experience in the Pharmaceutical industry and holds a PhD in chemistry. She originally came to Canada from Edinburgh, Scotland in 1995 to carry out her postdoctoral studies at the University of Western Ontario. Pauline is currently a member of the Royal Society of Chemistry, UK and is listed on the RSC Directory of Consultants. She was also member of the original USP expert panel for Validation, Verification and Transfer of Analytical Procedures and a member of a USP Chemical Medicines expert committee.
Pauline is an expert in quality systems and procedures, GMP regulations and analytical chemistry. Her experience in these roles has enabled her to become involved in troubleshooting and improving manufacturing processes (mainly of solid dose forms) through her validation programs, phase 2 investigations of OOS results, evaluation of changes/improvements to the process, assess the impact of these on the product/patient and propose and execute necessary revalidation criteria.She brings a technical expertise to laboratories and manufacturers which enable her to assist them to develop, transfer, verify and validate analytical procedures/processes, and also optimize efficiency with regards to operations and troubleshooting in development and routine 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. Pauline is a renowned trainer in her areas of expertise, a valuable consultant and a detailed oriented auditor.
Pauline’s passion is in the field of analytical QbD and application of the enhanced approach for analytical procedures to ensure reliable performance throughout their lifecycle of use. She has been involved in the evolution and advocacy of this topic since 2010.
She has utilized her skill set globally in the UK, Europe, Canada, US, Jordan, Brazil and China and has helped companies prepare for a GMP inspection to gain their European/Health Canada/FDA GMP licenses.
Throughout her career, Pauline has identified the need for bridging communication and documentation gaps. She experienced the need for Universities and Colleges to understand what industry required of their graduates. She saw how important it was for the Manufacturing, Quality Control, R & D and Quality Assurance sectors in the Pharmaceutical Industry to understand each other and find a way to communicate in the same language so that realistic objectives could be met by all in a timely manner.
PMcG Consulting was started to help bridge these gaps. This is achieved through training, consulting, document review and auditing services