Ms.Kelly Thomas

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 ...

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 ...

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 ...

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 ...

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 ...

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 ...

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 co ...

This course will provide an overview of the requirements for aseptic and bulk manufacturing operations, including facility design, contamination controls and acceptable personnel behaviours. Cleanroom classifications and the techniques for proper cleaning and ...

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. ...