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.

6 results Found
Recorded Webinar

REACH and ROH Overview

REACH and RoHS conformity has banned problematic toxic and environmentally hazardous elements such as lead, mercury, cadmium, hexavalent chromium, polybrominated biphenyls (PBB), and polybrominated diphenyl ether (PBDE) in quantities not exceeding a maximum of ...

  • Intermediate
  • 90 Mins
Recorded Webinar

Developing And Managing An Effective Change Control Program

Regulatory agencies require pharmaceutical and medical device companies to have a systematic approach to managing all changes made to a facility, its product, or a quality system. Given the fact that changes are inevitable, it is essential that companies have ...

  • Basic & Intermediate & Advanced
  • 90 Mins
Recorded Webinar

Establishing A Robust Supplier Management Program

Regulatory expectations are clear about manufactures’ responsibility regarding supplier quality oversight.All regulatory agencies agree that pharmaceutical and medical device manufactures are responsible for ensuring their suppliers adhere to quality standards ...

  • Basic & Intermediate
  • 90 Mins
Free 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 will be discussed; incl ...

  • Intermediate
  • 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 disclosing foods th ...

  • Basic & Intermediate & Advanced
  • 60 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 with the regulations. ...

  • Intermediate
  • 90 Mins