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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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Showing 1 to 11 of 11 (1 Pages)
$200.00
Analytical Method Validation and Transfer

 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..

$200.00
Cleanroom Microbiology and Sterility Assurance

 Kelly Thomas
 Recorded Webinar
 90 Minutes
Cleanroom Microbiology and Sterility Assurance

This course will educate you about various key elements of sterility assurance and contamination control such as Cleanroom Regulations, Classification, Sources, and types of particles, Design Requirements, Validation/Qualification, Operations, Environmental Monitoring Program requirements, Excursion investigations, DataTrending, Microbiological processes/methodology, Cleanroom cleaning/disinfection. The typ..

$200.00
Data Integrity 21 CFR Part 11 Compliance

 Kelly Thomas
 Recorded Webinar
 90 Minutes
Data Integrity 21 CFR Part 11 Compliance

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 data integrity issues. As a result, industry guidance and enforcement strategies are evolving. Regulatory concerns and warning letters have extended to..

$200.00
Establishing a Robust Supplier Management Program

 Kelly Thomas
 Recorded Webinar
 90 Minutes
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..

$200.00
Establishing Appropriate Quality Metrics and Key Performance Indicators (KPIs)

 Kelly Thomas
 Recorded Webinar
 90 Minutes
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 performance. This course will discuss the importance of establishing metrics, how to distinguish Key Performance Indicators (KPIs), as well as, how to utilize t..

$200.00
GMP for QC Laboratory Compliance

 Kelly Thomas
 Recorded Webinar
 90 Minutes
GMP for QC Laboratory Compliance

In the manufacture and quality control of medicinal products, compliance with the GMP rules is the decisive aspect of manufacturing high-quality products. For this reason, every staff member in the pharmaceutical industry has to be familiar with the basic GMP requirements.Learning ObjectivesThe Good Manufacturing Practice Program provides a comprehensive overview of the best practices regarding the manageme..

$200.00
New FDA Draft Guidance Part 11 Compliance

 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..

$200.00
Implementing a Robust Data Integrity Program

 Kelly Thomas
 Recorded Webinar
 90 Minutes
 Download Catalog
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 the topic during compliance inspections. Multiple FDA warning letters and EU GMP non-compliance reports have highlighted major data integrity failures and falsification w..

$200.00
Implementing Appropriate Quality Metrics and Key Performance Indicators (KPIs)

 Kelly Thomas
 Recorded Webinar
 90 Minutes
 Download Catalog
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 ..

$200.00
Understanding the Drug Supply Chain Security Act: Latest Regulatory Developments and Best Practices

 Kelly Thomas
 Recorded Webinar
 90 Minutes
 Download Catalog
Understanding the Drug Supply Chain Security Act: Latest Regulatory Developments and Best Practices

The Drug Supply Chain Security Act (DSCSA) outlines requirements for pharmaceutical manufacturers, repackagers, wholesale distributors, dispensers, and third-party logistics providers. Some requirements began in November 2014 and several key requirements began at various stages in 2015. The requirements, development of standards, and the system for product tracing will continue to be phased in until 2023. H..

$200.00
USDA New Proposed Rule on BioEngineered (GMO) Food Disclosure

 Kelly Thomas
 Recorded Webinar
 60 Minutes
 Download Catalog
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..

Showing 1 to 11 of 11 (1 Pages)