Speed To Market And Beyond

March 28, 2023 || R. Filannino Leave your thoughts
 
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…

Role Based Talent for Operational Readiness

March 28, 2023 || Harry Benson Leave your thoughts
 
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…

Developing Effective Procedures

March 28, 2023 || Jeff Hall & Lisa Hawkins Leave your thoughts
 
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…

Assess and Execution: Operational Readiness

March 28, 2023 || Leave your thoughts
 
Why CAI? A Cell Therapy Company is building a manufacturing facility in Newark, CA to produce novel CAR-T therapeutic products and sought an Operational Readiness partner with expertise in Cell & Gene Therapy facilities and CAI was selected. Project Overview Allogenic C&GT company built a manufacturing facility in Newark, CA…

Operational Readiness Through The Lens Of Capital Project Management

March 28, 2023 || Josh Hoops Leave your thoughts
 
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…