There are constant references in the regulations to the Quality Management System, or QMS, expected to be in place at every GxP-compliant site. The QMS is generally described in the Quality Manual and ...
India, 21st Oct 2024, - In the modern manufacturing landscape, ensuring that operations adhere strictly to Standard Operating Procedures (SOPs) is crucial for maintaining product quality and ...
Design is a commonly outsourced process. As with all services, it requires significant quality considerations. The ability to implement a seamless and sound quality management system (QMS) for a ...
Siegfried Schmitt, Principal Consultant, PAREXEL International, discusses standard operating procedures for the regulatory affairs department. Siegfried Schmitt, Principal Consultant, PAREXEL ...
Siegfried Schmitt, PhD, Principal Consultant at PAREXEL, discusses how to mitigate risk in a global regulatory environment. Q: During a recent inspection by the Chinese regulatory authority, we were ...
According to FDA, medical devices are distinguished from other discretely manufactured products because devices are “intended to affect the structure or any function of the body of man.” 1 By contrast ...
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