In the past, Coda’s blog has covered many initiatives undertaken by the Food and Drug Administration that were developed in order to improve regulatory strategies, and agency systems and tools.  These improvements were developed and implemented in the hopes of contributing to industries’ efforts to develop new and safe therapies as quickly as possible and […]

The Difference Between?  Working in such a tightly regulated and hugely competitive industry and dealing with technologies that can at times be controversial, I expect to hear heated debates or energetic discussions regarding the nature and/or value of regulations, cutting edge technologies, or free market price wars.  Because of the nature of our industry, I […]

My career began in typical fashion, in the corner of a QC lab working for a mid-sized multi-national pharmaceutical company.  But the path from that point forward was anything but typical; in less than a decade, the site was sold 4 times, technology was transferred in and out and then in again, and between owners […]

 Recently, several questions were submitted by readers, seeking clarity on the fine line between the stages of design and validation.  While preparing individual answers to each question, we noted that dealing with them as a group presented an opportunity to address fundamental concepts comprehensively. This month’s blog is dedicated to highlighting the very real differences, […]

In this blog we will examine what is perhaps the most useful tool in the belt of today’s quality professionals: risk management. Critical Terminology Prior to discussing the topic at hand, I like to provide context for the terminology integral to the concept. The first step on the road to effective system development is alignment […]

Market reports indicate that drug and device manufacturers have been adapting traditional models, trending toward heavier usage of contracted suppliers of critical functions such as manufacturing (CMOs) and research (CROs).  Trends suggest that this will continue over the next decade.  A review of figures for the last decade reveal that outsourced manufacturing by pharma and […]

Recently, a colleague who is a college instructor noted that one of his students asked, “Is Lean still a good idea?” This prompted the teacher to solicit opinions from those of us that toil each day in the world of manufacturing. I typed a short reply.  As I was typing, I realized that while the […]

I have worked within and around the life sciences community of Quality professionals for more years than I am ready to admit in a public post.  Early on in my career, I listened avidly to every experienced person that I worked with, eager to take in everything anyone had to teach me.  I was the […]

Too often Corrective and Preventative Action (CAPA) programs are considered solely with regard to Deviation Management programs. Modern Quality Systems, including CAPA programs, have been a focus of international harmonization efforts and the FDA’s 21st Century Initiative Program. Both initiatives seek to align the industry, and promote aggressive, proactive programs that drive toward continual process […]