Ms. Thomas has over two decades of cGMP hands-on industry experience in both pharmaceutical and medical device manufacturing operations. Her experience covers all Quality Systems; as well as, all areas of validation; including, process/product validation, facilities validation, 21 CFR Part 11, test method validation, equipment/automated processes and cleaning validation.
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 ...
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 ...
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 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 ...
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. ...
