Compliance
Supplier Management
July 10, 2018
Implementing a Risk-Based Supplier Management Program
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,...
FDA
CAPA
January 11, 2017
CAPA is not a difficult concept, so why do many companies have difficulty managing it?
CAPA is not a difficult concept, so why do many companies have difficulty managing it?: If keeping up with CAPA is a challenge for your company's cGMP quality system, I hope that this article...
Quality Assurance
Life Science Consulting
September 7, 2016
Does Your Training Program Have Traction?
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...
Quality Assurance
Life Science Consulting
May 11, 2016
Does your Quality System stand up to the challenge?
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...
Quality Assurance
Life Science Consulting
March 9, 2016
Gravity and Quality Assurance
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,...
Quality Assurance
Life Science Consulting
March 25, 2015
CAPA and the Importance of Effective Technical Writing
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...
Quality Assurance
Life Science Consulting
September 10, 2014
Sneak Preview: What Will the Quality Metrics Initiative Look Like?
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...
Quality Assurance
Life Science Consulting
June 27, 2014
Who Owns Quality?
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...
Quality Assurance
Life Science Consulting
November 26, 2013
Why Measure and Report Quality Metrics?
A wise man recently told me that “honor and respect should be given freely, but trust is earned”. Whether it’s in politics, friendships, church, marriages, parenting or even the business world,...