Tiffany A. Baker

Consultant, Valsource Inc

Tiffany Baker is a Senior Consultant at ValSource, LLC, specializing in development and implementation of innovative approaches to quality risk management (QRM), QRM program design, creating a risk-focused culture, and developing risk-based approaches to support contamination control strategies. Tiff is an active member of ISPE and the Parenteral Drug Association (PDA), a faculty member for PDA’s Training Research Institute, and an instructor for the PDA courses on quality risk management foundations, practical application of QRM tools, and QRM for the design, qualification, and operation of manufacturing systems. She is co-lead for the PDA Task force on remote audits and inspections. Additionally, she was an author for the revision to ISPE Baseline guide 5 - Commissioning and Qualification, incorporating QRM into the process as well as a chapter on Principles of QRM for Validation in the recently published “Process Validation in Manufacturing of Biopharmaceuticals, 4th Edition”. She has a BS in microbiology from the University of Rhode Island and an MBA from Providence College. She can be reached at