Resources - CAI

Good Manufacturing Practices Audits

CMO Validation as a Service

Aseptic Expertise and Delivery of Services

Elevate Your Project by Going Lean: The Benefits of Incorporating Lean Methodologies into Project Management

By Pat Hayes

New EU Medical Device (EU 2017/745)

Facility Vision

ModelSync

Project Vision

Quality Operations Support

Delving into the FDA’s Guideline: An Overview of CAR T-Cell Product Development and Clinical Protocols

Digital System Implementation

POLITICS IN PROJECT MANAGEMENT: The Missing Power Skill

By Erik Adams

Regulatory Support and CTD Writing for Tech Transfer Project

Site Strategic Master Plan

By Luisa Puglisi

SAP S4HANA Implementation

By Connie Leech

Environmental Monitoring Performance Qualification (EMPQ) and Validation Support Services

By Connie Leech

Laboratory Equipment Qualification Process

Alofisel P3 Cell Therapy Facility

Optimizing Process Loads for VHP Decontamination – Takeda P3

Project Communication Management

By Patrick Hayes