Kelly Thomas
Vice President, Americas Quality Operations at Stallergenes Greer
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.
Upcoming Webinar
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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 analysis can generate valid data upon which business and regulatory decisions can be made. FDA, ICH, and USP have each recognized the importance of this relative to the drug development process and have each expanded method validation requirements in recent years. However, with only limited guidance, the industry has been left to interpret how to adequately comply with the regulations. This course provides a comprehensive overview of the international regulatory authority requirements and expectations for test method validation of these assays.
Recorded Session Get life time access for one participant with download option!

Implementing the ASTM E2500 Validation Method
This validation training program will discuss regulatory requirements from the FDA, EU and ICH perspective, review all the detailed guidance on the concepts found in ASTM E2500 to help industry professionals understand how to implement a validation program based on the ASTM 2500 Approach.
Recorded Session Get life time access for one participant with download option!

Implementing 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. This course will also discuss the latest draft guidance from the FDA in regards to Quality Metrics.
Recorded Session Get life time access for one participant with download option!

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, maintain compliance to regulatory requirements and consistently meet established expectations. Therefore, it is essential pharmaceutical and medical device organizations develop and implement a robust supplier management program.
Recorded Session Get life time access for one participant with download option!

Establishing a Compliant and Effective Change Control Program
This Change Control training course will discuss regulatory expectations from the FDA, EU and ICH perspective, review all the required components of a thorough Change Control program; as well as, discuss the elements regarding successful management an effective Change Control system.
Recorded Session Get life time access for one participant with download option!

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