E-Pub: The Importance of Annex 1
Annex 1 - "Manufacture of Sterile Medicinal Products." was first published in 1971. However, the first revision since then is currently in process. And this...
Read More
Why I Chose CAI to Incubate and Accelerate my Career
I have two guiding principles that I rely on when making career decisions. Compounding experience and future opportunity. (more…)
Read More
Moving the Goalposts?
Can a standard Corporate Scoring Framework be applied across the spectrum of Quality Risk Management? (more…)
Read More
Int’l Women’s Day: An Open Letter to my Most Inspirational Colleague
Have I ever told you how much I want to be just like you? I am so thankful for the opportunity to work alongside the...
Read More
In Review: Facilities of the Future Conference
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...
Read More
Data Centers are Constantly Evolving
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...
Read More
The Low Down on a New Packaging Serialization Standard
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...
Read More
Applying Six Sigma Principles to Operations: The Voice of the Customer
What is the “Voice of The Customer”? Is it only external customers? The end users? What about internal customers? Do they have a “voice” as...
Read More
Applying Six Sigma Principles to Client Operations: Waste
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...
Read More