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 Webinars
Chronicles
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
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
By: Kelly Thomas
Recorded Session
Aseptic Process Validation: Top-Tips for Compliance and Success
Validation of aseptic processes is essential to ensuring the successful end result for manufacturers – a safe, effective finished product. However, the process starts long before that.…
Industry: FDA Compliance Duration: 90 Minutes
By: Kelly Thomas
Recorded Session
Writing Effective 483 and Warning Letter Responses
The outcome of regulatory inspections is critical to an organization’s success. The FDA performs inspections to check that companies are maintaining compliance with applicable regulations an…
Industry: FDA Compliance Duration: 90 Minutes
By: Kelly Thomas
Recorded Session
Cleanroom, Microbiology and Sterility Assurance Practices for Drug and Device Manufacturers
This course will educate you about various key elements of sterility assurance and contamination control such as Cleanroom Regulations, Classification, Sources, and types of particles, Design Requ…
Industry: FDA Compliance Duration: 90 Minutes
By: Kelly Thomas
Recorded Session
Establishing Appropriate Quality Metrics and Key Performance Indicators (KPIs)
Establishing appropriate Quality Assurance metrics is important for several reasons. Metrics not only measure the health of your quality system, but they also have the ability to change beha…
Industry: FDA Compliance Duration: 90 Minutes
By: Kelly Thomas
Recorded Session
Implementing a Robust Change Control Program - Key Elements for Process and Documentation Compliance
Regulatory agencies require pharmaceutical and medical device companies to have a systematic approach to managing all changes made to their facilities, products, and/or quality systems. Give…
Industry: FDA Compliance Duration: 90 Minutes