February 19, 2024
This article has been updated since its original publication date. Navigating the complexities of Corrective Action / Preventive Action (CAPA) in the drug and medical device industries often poses a...
October 27, 2023
A typical post-merger integration (PMI) between two companies is challenging, time-consuming, stressful, and resource intensive. Even the companies most experienced with integration find these...
July 10, 2018
According to recent FDA updates on the implementation of the Safety and Innovation Act (FDASIA), nearly 40 percent of finished drugs are being imported, and nearly 80 percent of active ingredients,...
September 7, 2016
With the spotlight these days on Data Integrity, it may be easy to lose sight of some fundamental Quality Systems. Core Quality Systems include Document Management, Investigation Management, and...
May 11, 2016
Implementing and maintaining a Quality System is a complex challenge. It is as much as an art as it is a science. A company’s Quality System establishes the framework to manage and maintain...
March 9, 2016
As we’ve now moved on from another cold winter month, I was captivated recently thinking about Quality Assurance and our collective responsibilities. All kinds of things come to mind; Deviations,...
March 25, 2015
My apologies to you in the technical writing profession out there, but there are not too many topics that are as bland and unappealing as technical writing. Personally, I'd rather step on a sharp...
September 10, 2014
I had lunch in a restaurant the other day. During my meal, I noticed that there weren't many other customers. I didn't give it much thought until I walked out and read the restaurant's hygiene grade...
June 27, 2014
When it comes to the Healthcare industry (e.g. pharmaceuticals, medical devices, dietary supplements, etc.) who owns a company's Quality Assurance practices? Without a doubt the Quality organization...