Ms.Kelly Thomas

This webinar will discuss the FDA requirements and guidelines for investigating Out-of-trend (OOT) results in the pharmaceutical laboratory. It will also cover FDA compliant documentation of OOT, failure investigations, root causes and CAPA.

REACH and RoHS conformity has banned problematic toxic and environmentally hazardous elements such as lead, mercury, cadmium, hexavalent chromium, polybrominated biphenyls (PBB), and polybrominated diphenyl ether (PBDE) in quantities not exceeding a maximum of ...

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 ...

In the manufacture and quality control of medicinal products, compliance with the GMP rules is the decisive aspect for manufacturing high-quality products. For this reason, every staff member in the pharmaceutical industry has to be familiar with the basic GMP ...

The types of micro-organisms, typical mitigation steps in ensuring an effective contamination control through Personnel Training (Aseptic Practices, Cleanroom Behavior, and Contamination Control Procedures), Gowning Controls, Personnel Training, Cleanroom Traf ...

Regulatory agencies require pharmaceutical and medical device companies to have a systematic approach to managing all changes made to a facility, its product, or a quality system. Given the fact that changes are inevitable, it is essential that companies have ...

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 ...

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 ...