Ms. Kelly Thomas

Area Of Expertise : Medical Devices
20 Years Of Experience
Training Industry : Life Sciences

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,  21 CFR Part 11, test method validation, equipment/automated processes and cleaning validation.

4 results Found
Live Webinar

How to Author an Effective 483 and Warning Letter Response

This course will discuss the importance of developing and submitting a robust, timely response to FDA 483 observations or warning letters; as well as, educate the audience on the essential elements of a thorough response. Additionally, this ...

  • Intermediate
  • 90 Mins
  • Apr 10, 2019
Live Webinar

Establishing Appropriate Quality Metrics and Key Performance Indicators (KPIs)

This course will discuss the importance of establishing metrics, how to distinguish Key Performance Indicators (KPIs), as well as, how to utilize those metrics to drive Quality Culture. Metrics for numerous departmental functional areas wil ...

  • Basic & Intermediate
  • 90 Mins
  • Apr 15, 2019
Recorded Webinar

Aseptic Processing Overview and Validation

This course will provide an overview of the requirements for aseptic and bulk manufacturing operations, including facility design, contamination controls and acceptable personnel behaviours. Cleanroom classifications and the techniques for ...

  • Basic & Intermediate
  • 90 Mins
Recorded Webinar

ASTM 2500: Lessons Learned Through a Decade of Implementation

This course provides detailed guidance on the concepts of ASTM 2500 and how to implement a validation program based on that approach. With limited guidance and experience, the industry has been left to interpret how to adequately comply w ...

  • Intermediate
  • 90 Mins