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
Cleanroom, Microbiology and Sterility Assurance Practices for Drug and Device Manufacturers
Sterility assurance and contamination control depend on how well a cleanroom is designed, qualified, run and monitored. This 90-minute cleanroom, microbiology and sterility assurance training cove…
Industry: FDA Compliance Duration: 90 Minutes
By: Kelly Thomas
Recorded Session
Establishing Appropriate Quality Metrics and Key Performance Indicators (KPIs)
The right quality metrics do more than report on the health of your quality system. They shape behavior, build quality culture and improve individual and company performance.
This 90-minute …
Industry: FDA Compliance Duration: 90 Minutes
By: Kelly Thomas
Recorded Session
Writing Effective 483 and Warning Letter Responses
FDA inspections check that companies comply with the regulations and quality standards that apply to them, and even well-run firms can receive a Form 483 or warning letter. Because responses are d…
Industry: FDA Compliance Duration: 90 Minutes
By: Kelly Thomas
Recorded Session
Implementing a Robust Change Control Program - Key Elements for Process and Documentation Compliance
Regulators expect pharmaceutical and medical device companies to manage every change to facilities, products and quality systems in a systematic way. This 90-minute change control training explain…
Industry: FDA Compliance Duration: 90 Minutes
By: Kelly Thomas
Recorded Session
Aseptic Process Validation: Top-Tips for Compliance and Success
Aseptic process validation is what gives manufacturers confidence in a safe, effective finished product, and the work starts with achieving the right sterility assurance for active ingredients and…
Industry: FDA Compliance Duration: 90 Minutes
By: Kelly Thomas
Recorded Session
Analytical Method Validation and Transfer Course
Pharmaceutical decisions depend on analytical methods that produce valid data on a product's safety, identity, strength, purity and quality. This 90-minute analytical method validation and transfe…
Industry: FDA Compliance Duration: 90 Minutes
By: Kelly Thomas
Recorded Session
FDA Compliant Handling of Out-of-Trend Results in Pharmaceutical Quality Control
FDA's guidance on investigating out-of-specification (OOS) test results calls for failure investigations, and notes that much of it can also help when examining out-of-trend (OOT) results. This 90…
Industry: FDA Compliance Duration: 90 Minutes