Second Family
On the friendships we build at work and the one I lost six years ago today. Six years. I think about it every September 18th, and the time passed doesn’t make it less difficult. On...
Read MoreJackie Torfin
Printing Electronic Data Doesn’t Solve Your Data Integrity Problem
And in 2026, that misunderstanding costs more than ever It happens at least a few times a year as I work with pharma, biotech, and medtech clients. We start talking about computerized system use or...
Read More
60 and Still a Queen: Reflections on a Life in Quality
It’s my 60th birthday. For many, this is a time to slow down, to look back, and to maybe even relax. But if you know me, you know that’s not quite my style. Yes, I...
Read More
The Best Lessons I Ever Learned Came From a Man With a Meat Cleaver
A Father’s Day reflection on ribs, risk, and raising a quality leader My father could break down a side of beef before most people had finished their morning coffee. He was a butcher, a craftsman...
Read More
The First Quality Leader I Ever Knew: Lessons from Mom
In medical devices and pharmaceuticals, we talk a lot about quality systems, CAPAs, and regulatory compliance. But after thirty-five years in this industry, from the clinical lab to the boardroom, I’ve realized that the most...
Read More
The FDA’s New Playbook: Preparing for Inspections Under the QMSR
As of February 2, 2026, the medical device industry officially entered a new regulatory era. The long-anticipated transition is complete: the Quality Management System Regulation (QMSR) has modernized 21 CFR Part 820 by integrating ISO...
Read More