Archives

Planning for a Talented Workforce: Building a Staffing Plan for New or Expanding GMP Facilities
Blog Post

Planning for a Talented Workforce: Building a Staffing Plan for New or Expanding GMP Facilities

Let’s contrast two very real scenarios: You are responsible for bringing a new GMP facility or line to full-scale production. Your board or shareholders expect...

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Erik Adams Named Global Director of Program Project Management

INDIANAPOLIS, Indiana, January 3, 2023 – Commissioning Agents Inc. (CAI) announces Erik Adams named Global Director of Program Project Management (PPM). In this role, Erik...

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Use of Artificial Intelligence and Machine Learning (AI/ML)

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...

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Kneat and CAI:  Building the Future of Validation Together

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...

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Quality Mindset on High-Risk Projects

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...

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Release of the FDA Draft Guidance “Computer Software Assurance for Production and Quality System Software”: Key Notes

INTRODUCTION Recently, the Compliance and Quality team at the CDRH of the FDA issued the long-awaited draft guidance: “Computer Software Assurance for Production and Quality...

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ISPE │ GAMP5 – A Risk-based Approach to Compliant GxP Computerized Systems, Second Edition: Presentation of the Major Changes

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...

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What’s New in GAMP5 Edition 2?

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...

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CAI Named AIBF All-Star Multinational Of The Year 2022

Leading Multinational Achieve Top Irish Business Accreditation CAI Named AIBF All-Star Multinational Of The Year 2022 Leading global engineering, technical and consulting company CAI have...

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CAI’s Kneat Gx System Qualified & Released for Use

June 17, 2022Indianapolis, IN Following the initial development of a strategic partnership with Kneat Solutions in early 2022, CAI has today confirmed its status as...

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New email domain, same CAI. We’re updating our emails to match our web domain. Full transition by October 3.