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.

10 results Found
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
  • Dec 19, 2019
Recorded Webinar

Food Safety Modernization Act Prevention Controls: Cross Contact and Cross Contamination

About 48 million people in the U.S. (1 in 6) get sick, 128,000 are hospitalized, and 3,000 die each year from foodborne diseases, according to recent data from the Centers for Disease Control and Prevention. This is a significant public hea ...

  • Basic & Intermediate & Advanced
  • 90 Mins
Recorded Webinar

USDA New Proposed Rule on BioEngineered (GMO) Food Disclosure

The USDA announced the National Bioengineered Food Disclosure Standard on December 20, 2018. The National Bioengineered Food Disclosure Law, passed by Congress in July of 2016, directed USDA to establish this national mandatory standard for ...

  • Basic & Intermediate & Advanced
  • 60 Mins
Recorded 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
Recorded Webinar

Implementing a Robust Data Integrity Program

Data integrity is defined as the maintenance of, and the assurance of the accuracy and consistency of, data over its entire life-cycle.  Data Integrity is a global issue with both FDA and the European Regulatory Agencies majorly focusing on ...

  • Basic & Intermediate & Advanced
  • 90 Mins
Recorded Webinar

Overview of FDA's Risk Evaluation and Mitigation Strategy (REMS)

Risk Evaluation and Mitigation Strategy (REMS) is a drug safety program that the U.S. Food and Drug Administration (FDA) can require for certain medications with serious safety concerns to help ensure the benefits of the medication outweigh ...

  • Basic & Intermediate & Advanced
  • 90 Mins
On-Demand 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
Recorded 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
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