Blog
March 17, 2023 ||
As St. Patrick’s Day approaches, we at CAI take great pride in celebrating the accomplishments of our agents in Ireland. Our Irish team has made invaluable contributions to our company’s success and growth, and we want to take this opportunity to acknowledge their hard work and dedication. Ireland has long…
February 3, 2023 || David Shenberger
INDIANAPOLIS, Feb. 2, 2023 – Commissioning Agents Inc. (CAI) announced Nick Armstrong has been named the Initial Senior Director of Digital Enablement, as CAI continues our investment in Digital Transformation for both our internal programs and our clients’ operations. Mr. Armstrong has 15 years of experience in the Biopharmaceutical, Food,…
January 3, 2023 || David Shenberger
INDIANAPOLIS, Indiana, January 2, 2023 – Commissioning Agents Inc. (CAI) announced that Wesley Vestal has been named CAI’s Chief People Officer. In this role, Wesley will be responsible for leading CAI’s global human resources team, utilizing his background in leadership development, strategic workforce planning, and systems implementation to transform clients’…
January 3, 2023 || David Shenberger
INDIANAPOLIS, Indiana, January 3, 2023 – Commissioning Agents Inc. (CAI) announces Erik Adams named Global Director of Program Project Management (PPM). In this role, Erik will be responsible for leading CAI’s global program and project management team, growing the PPM business services, and develop tools and processes to drive client…
December 8, 2022 || Laurent Saugrin
This article is the first of five (5) articles that fall under the umbrella of the paper “ISPE│GAMP5 – a risk-based approach to compliant gxp computerized systems, second Edition: PRESENTATION OF THE Major Changes” released in October 2022. INTRODUCTION The broad scope of digital health includes categories such as health…
October 24, 2022 || Jon Thompson
Building the Future of Validation Together was the title of a recent webinar co-presented by Rick Mineo, Director of Strategic Partnerships at Kneat and Aaron Roth, Associate Director, Global C&Q, CAI. The webinar can be found here: https://kneat.com/webinars/. This title perfectly sums up the growing relationship that was formalized just…
October 7, 2022 || Lana Caperton
From client project kick-off to ribbon cutting, a high-risk project can be controlled if quality behaviors and expectations are exercised and embraced by the Team throughout the process. Drivers for client projects include getting drug product to more patients at a lower cost (expansion of new process trains and scale…
September 19, 2022 || Laurent Saugrin
September 1, 2022 || Eric Collier and Laurent Saugrin
INTRODUCTION The scope of this article includes the major technical content changes that have been made in the newly released Second Edition of the ISPE│GAMP5 A Risk-Based Approach to Compliant GxP Computerized Systems guide. This article lists these changes, and points to the applicable sections and/or appendices that have been…
August 22, 2022 || Eric S. Collier
It’s here, it’s here! I’ve felt like Navin R. Johnson waiting for the new phone book to arrive. (You might have to Google this one if you’re under age 50.) The Second Edition of GAMP5 is out! My colleagues and I have had a chance to review and will be…
