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Quality Systems Insights

The Little "c" Isn’t What It Used To Be!

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 […]

Think Systems: Cause Quality

November, 2012 was celebrated as “World Quality Month.” ASQ CEO Paul Borawski asked this of industry: “What do you use as the best, most inclusive and illuminating definition of quality?” I followed the trail of replies as they posted, and it quickly became apparent to me just how diverse Mr. Borawski’s audience is, and how […]

Design and Validation – Drawing the Fine Line

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, […]

Cost Cutting and Quality

The last several years have been turbulent for the US pharmaceutical market.  Unfavorable economic conditions have hit all sectors of the global economy. Historically, the pharmaceutical industry has been relatively immune to the downswings of the global economic cycle because illness, which provides the opportunities for these pharmaceutical companies to create and produce drugs, never […]

The Biosimilar Guidance Documents; Industry Responds

Regulatory Summary In an effort to incentivize the market place to introduce competitively priced biologics, the Biologics Price Competition and Innovation Act, passed by the Senate in 2009, was signed into Federal Law as part of the Patient Protection and Affordable Health Care Act by President Obama in 2010.  Among other components the BPCI Act: […]

Quality Control: Overhead or Profit Center?

I have recently joined Coda’s team of Quality System bloggers.  My professional background is rooted in the development and management of Quality Control Laboratories.  The experience working to create, export, streamline, maintain, improve, and manage QC labs has not only been enjoyable, but has also given rise to many valuable insights and lessons.  With that […]

Risk Management: A Primer for Lean Quality Assurance

Several of our previous blogs have been devoted to critical concepts and tools of Quality Systems.  In this month’s installment of the Quality System series, we will take a closer look at what is becoming perhaps the most useful tool in the belt of today’s Quality professionals: Risk Management. This blog has been designed for […]

Change Management and Change Leadership: A Critical (and Neglected) Relationship

We have previously published blogs that speak to leadership and management interests, exploring topics such as:  THE SUSTAINABLE VALUE OF LEAN TECHNIQUES – 07 June 2011 METHODS FOR CALCULATING AND REDUCING THE TOTAL COST OF QUALITY – 25 July 2011 GLOBAL DEPLOYMENT OF QUALITY SYSTEMS – 24 February 2011 This blog seeks to supplement the […]

The Industrial Revolution: Redux

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 […]

Is Lean Still a Good Idea?

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 […]