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Kelly Thomas

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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

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By: Kelly Thomas

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  

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By: Kelly Thomas

Recorded Session

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