ISPE Product Manufacturing Quality Metrics Initiative
ISPE commenced its Quality Metrics Initiative in June 2013 after the US Food and Drug Administration (FDA) announced its Quality Metrics Program in a February 2013 Federal Register notice. To assist in the evaluation of product manufacturing quality, FDA is exploring the broader use of manufacturing quality metrics.
WHITE PAPERS & CASE STUDIES
Clinical Trial Logistics In Africa: Ensuring Quality, Compliance And Control
Today’s Africa has increasingly become a source of fascination for pharmaceutical researchers drawn to the study and control of both communicable diseases such as malaria, tuberculosis and HIV/AIDS as well as diseases of the developed world like cancer, diabetes, hypertension and chronic respiratory disease. By World Courier
Exceeding GMP Of Medical Devices At Each Step In The Production Continuum
Through years, ATL has emerged as a leader in the manufacture of disposable medical devices. ATL is an FDA-registered medical device company whose custom disposable medical components are manufactured and shipped worldwide.
3 Tips For Safe, Secure Healthcare Shipping
All businesses need their shipments to go smoothly — nothing damaged, lost or late, and no last-minute surprises. And this is especially true in the healthcare sector, where a shipping mistake can cost not just dollars, but the health of a patient. By FedEx Custom Critical
Improving Quality Processes For Medical Device Development And Manufacturing
Organizations that consistently develop and launch new products efficiently in an environment of increasing regulatory scrutiny, successfully manage regulatory risk. By Mike Kuehne, ACSYS, Inc.
Selecting, Implementing, And Using FDA Compliance Software Solutions
We begin by asking the question, “Is the Quality Management Software market evolving to be easier, or more complex?”
eTMF And The eClinical Universe
How Electronic Trial Master Files (eTMFs) Work With Other eClinical Systems To Help You Meet Regulatory Requirements.