ZenQMS Blog » Quality-culture
Timothy Reinhardt
By Timothy Reinhardt on November 17, 2020

Shifts in the landscape of quality management training

When I started in the pharmaceutical industry nearly thirty years ago, training meant collecting large numbers of various staff members into a conference room on a slow day and methodically walking through a high-level general presentation packed with incidental information. This exercise was repeated annually for my first three years, with what seemed to me to only contain tiny alterations to the training material. Proficiency, engagement, and creativity were not a driving factor in the sessions. It seemed more about filling an afternoon and checking a box.
Mike Kent
By Mike Kent
on November 12, 2020

Tenth grade. High school. Speech class. Six words that, to most of us, including me, bring back various thoughts and emotions. Maybe one of those emotions is “fear”? But what if I told you that back then, and still today, you and I both have everything we need to be able to speak in front of a group of a thousand strangers? We are able to manipulate our mouth and breath in such a way as to generate words in a certain language.

But is “ability” or “competency” the desired outcome? 

Steve Diedrich
By Steve Diedrich
on September 15, 2020

As part of the Quality Leaders Forum, we sat down (virtually) with Steve Diedrich for a primer on compliance vs. quality and how we might use Simon Sinek's framework of "finite and infinite games" to think about quality management. Register now for "Playing the Infinite Game in Quality," an interactive forum with Steve Diedrich. 

Celia Brown
By Celia Brown
on February 24, 2020

Data integrity is at the heart of quality culture and everything we do in the life sciences industry. It is a term that is often used synonymously with regulatory compliance but they are not actually the same at all.  Whether or not you are building- or intending to build- commercial products, the data you are generating will later inform commercial filings and applications that will add value for the business. And so that data- and the ability to defend that data all the way back to the source- is very important. 

Celia Brown
By Celia Brown
on February 20, 2020

Whether it’s your first or fifth or five hundredth audit, you can never be too prepared. We recently hosted a webinar on exactly this topic, hosted by quality and systems expert Ed Morris. Morris walked through tips for preparation for and day of your audit.