Moving the Goalposts?

April 5, 2018 ||
Can a standard Corporate Scoring Framework be applied across the spectrum of Quality Risk Management?

In Review: Facilities of the Future Conference

February 27, 2018 ||
ISPE held its second Facilities of the Future conference.  The conference brought together over 160 professionals from pharmaceutical and biotech manufacturing, equipment suppliers, academics, and regulators.  Jim Breen, Vice President Lead Biologics Expansion, Janssen Pharmaceuticals, was the Program Planning Chair.  

Data Centers are Constantly Evolving

February 7, 2018 ||
Growing up, we did not have a home computer in my family until I was 11 years old. We were fortunate enough that my momma brought home an Apple desktop over the summer; my sister and I dedicated all of our computer time to Oregon Train and Number Munchers. (“Like”…

The Low Down on a New Packaging Serialization Standard

January 4, 2018 ||
Nine vendors and one end user recently conducted pilot tests to develop, evaluate, and validate a new serialization standard, PSS 1.0, officially released in November 2017. This group, known as the Open Serialization Communication Standard Group (Open-SCS), advocates that PSS 1.0 minimizes customization of plant-to-enterprise interfaces (Levels 3 and 4),…

Applying Six Sigma Principles to Client Operations: Waste

November 30, 2017 ||
Waste shows up in many forms and in all projects. This happens regardless of industry, product, or service being provided. Nothing is perfect, no matter how hard we try. That doesn’t mean that the effort to reduce waste is for nothing. Anytime waste can be removed from a product or…

Applying Six Sigma Principles to Operations: The Cost of Poor Quality

November 29, 2017 ||
The principles and methodology of Six Sigma are applicable to multiple industries and processes. In all cases, the primary reason these principles are implemented is to eliminate errors, to the greatest extent possible, before they happen. The only way to accomplish this is by starting with an honest assessment of…