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.

15 results Found
Live Webinar

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, they have the ability to change behavior, drive quality culture and improve both individual and company performanc ...

  • Basic & Intermediate
  • 90 Mins
  • Jun 09, 2023
Live Webinar

Analytical Method Validation and Transfer

This course provides guidance on how to perform QC analytical test method validations and transfers. One of the most critical factors in developing and marketing pharmaceutical drug substances and drug products is ensuring that the analytical methods used for ...

  • Basic & Intermediate & Advanced
  • 90 Mins
  • Jun 12, 2023
Live Webinar

GMPs for Virtual Companies

Participants in this seminar will: Understand the GMP and GCP requirements all virtual companies must meet regardless of the extent of their outsourcing operations. Understand how to select, qualify and monitor CMOs, CROs and Contract Laboratories. Learn ...

  • Basic & Intermediate & Advanced
  • 90 Mins
  • Jul 11, 2023
Live Webinar

FDA 483s Warning Letters And Enforcement Trends

The fiscal year 2019 saw the most warning letters issued by the FDA to makers of finished pharmaceutical products in recent history. During the last 12 months, a total of 81 warning letters were issued to finished product manufacturers worldwide, the most sinc ...

  • Basic & Intermediate & Advanced
  • 90 Mins
  • Jul 31, 2023
Live Webinar

Establishing A Robust Supplier Management Program

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

  • Basic & Intermediate & Advanced
  • 90 Mins
  • Aug 08, 2023
Live 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
  • Aug 29, 2023
Recorded Webinar

Data Integrity 21 CFR Part 11 Training

The importance and amount of data being generated to ensure product quality and patient safety continues to grow, and proper controls around that data continue to be a subject of regulatory scrutiny. Regulatory agencies across the world are repeatedly citing d ...

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

Implementing 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 standar ...

  • 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
Recorded Webinar

Analytical Method Validation and Transfer

This course provides guidance on how to perform QC analytical test method validations and transfers. One of the most critical factors in developing and marketing pharmaceutical drug substances and drug products is ensuring that the analytical methods used for ...

  • Intermediate
  • 90 Mins