Ms.Kelly Thomas

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 ...

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 ...

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 ...

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 ...