The CMTI students met with Dr. Dirk E. Stevens, Sr. Vice President of Quality Systems and Regulatory Affairs at Fresenius Medical Care as a guest speaker in BME432.
Dr. Stevens spoke about Manufacturing Processes and Controls. His presentation touched on: Good Manufacturing Practices (GMP), Establishment Registration, Validation, CAPA, and Risk Management.
Fresenius Medical Care North America is the premier health care company focused on delivering the highest quality care to people with renal and other chronic conditions. Worldwide, more than 2.5 million patients with this disease regularly undergo dialysis therapy, a vital blood cleansing procedure that substitutes the function of the kidney in the case of kidney failure.
Fresenius Medical Care encompasses an industry-leading network of more than 2,200 dialysis facilities, outpatient cardiac and vascular labs, and urgent care centers, as well as the country’s largest practice of hospitalist and post-acute providers.