Speaker Profile
KELLY THOMAS
Ms. Thomas has over two decades of cGMP hands-on industry experience. Her experience covers both Quality Assurance; as well as, Quality Control. Ms. Thomas holds a Bachelor or Science degree in Microbiology and a Masters Degree in Business Administration.
Utilizing strategic thinking, risk based approaches, and Lean principles, she has demonstrated success in steering and managing complex projects within the cGMP industries.
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Kelly Thomas
Recorded Webinar
90 Minutes
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 thi..
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Kelly Thomas
Recorded Webinar
90 Minutes
New FDA Draft Guidance Part 11 Compliance
This webinar describesAs part of the Case for Quality program US FDA noted how an excessive focus by the industry on compliance rather than quality may be diverting resources and management attention toward meeting regulatory compliance requirements vs. adopting best quality practices. There has also been a lower-than-anticipated investment in automation and digital technologies, which could greatly improve..
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Implementing 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, but they also have the ability to change behavior, drive quality culture, and improve both individual and company performance. This course will discuss the importance of establishing metrics, how to distinguish Key Performance Indicators (KPIs), as well as, how to ..
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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 that are or may be bioengineered. The standard will provide a uniform way for food manufacturers to disclose whether food or its ingredients were bioeng..