Kelly Thomas

Kelly Thomas
Ms. Thomas has over two decades of cGMP hands-on industry experience in both pharmaceutical and medical device manufacturing operations. Her experience covers all Quality Systems; as well as, all areas of validation; including, process/product validation, facilities validation, CSV and 21 CFR Part 11, test method validation, equipment/automated processes and cleaning validation.
Utilizing strategic thinking, risk based approaches, and Lean principles, she has demonstrated success in steering and managing complex projects within the pharmaceutical and medical device industries.
Live Webinar
Recorded Session
FDA Compliant Handling of Out-of-Trend Results in Pharmaceutical Quality Control
This webinar will discuss the FDA requirements and guidelines for investigating Out-of-trend (OOT) results in the pharmaceutical laboratory. It will also cover FDA-compliant documentation of OOT, …
Industry: FDA Compliance Duration: 90 Minutes
Analytical Method Validation and Transfer Course
This course will provide a thorough review of regulatory guidelines on method validation and transfer. It provides guidance on how to perform QC analytical test method validations and transfers.…
Industry: FDA Compliance Duration: 90 Minutes