Strong Data Is Generated By Strong People
By Joanna Gallant, Joanna Gallant Training Associates
In the event you’ve been living under a rock for the last several months, facility inspection information released by FDA has thrust data integrity into the spotlight. As someone who had responsibility for assuring laboratory data quality in the past, I find the recent spate of issues reported in FDA warning letters and 483s to be extremely disconcerting. Each subsequent revelation becomes more unbelievable. The good news is that steps to ensure data integrity are completely within our control – assuming we will put the time into executing them.
WHITE PAPERS & CASE STUDIES
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
Raising Expectations Of Excipients
An excipient’s role has traditionally been viewed as merely a filler or binder contributing to the stability of the end product. The full value that a formulation can bring to a final dosage form; or the real importance of ensuring an excipient’s quality and performance; are often underestimated, overlooked, misunderstood, or disregarded. In reality, the functionality of the excipient can help determine whether or not a drug succeeds or fails. By Fred Monsuur, Julia Poncher W. R. Grace & Co
Help Keep Pharmaceuticals Safe: Metal Detection Overview And Guidelines
Using metal detection as a means of identifying foreign object contamination has been prevalent in the food industry for decades. Although metal detection has also been in use to identify the presence of ferrous, non-ferrous, or stainless-steel contaminants throughout the past 40 years in the pharmaceutical industry, it has not been widespread.
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.
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
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?”