March 28, 2023 || R. Filannino
EXECUTIVE SUMMARY The competitive market demands rapid introduction of new GMP products. Manufacturing organizations configure their production systems to achieve the necessary agility and flexibility to rapidly develop and manufacture new GMP products at full-scale. But the market also demands reliable and inexpensive sources of existing GMP products. Many manufacturing…
March 28, 2023 || Rich Tree
INTRODUCTION Following any tech transfer project, the subsequent startup of the manufacturing line is almost always full of challenges. The goal is to startup as soon as possible once the project is completed but also to achieve steady state throughput as quickly as possible after the startup begins. This type…
March 28, 2023 || Harry Benson
As capital projects and technology transfers wrap up and facilities grow nearer to startup, site leaders and team members may be filled with a sense of excitement or dread depending on their confidence in the site’s operational readiness. Among the many workstreams of focused effort required to achieve readiness, the…
March 28, 2023 || Jeff Hall & Lisa Hawkins
Start With Why Needing to develop or update your procedures? Are you sitting at your computer starting to write procedures for every subject discussed in regulations and standards, addressing each statement with a procedural step? Put the procedure template away. The first step to writing effective procedures is in understanding…
March 28, 2023 || Josh Hoops
EXECUTIVE SUMMARY Achieving Operational Readiness on any Capital Project is a milestone event and should be integrated into every aspect of the Lifecycle of Project Delivery. Historically, Capital Project Management focuses on the delivery of the facility, the equipment, and supporting infrastructure. A good Project Manager will manage the five…
