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Developing Effective Procedures

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 WHY you are writing that procedure.

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FEATURED

Blog

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 you to have thought of everything that requires funding without excessive capital or operational budget overrun.

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FEATURED

Case Study

Performance Dashboards Development

A biotech company, preparing to launch its first drug batches, needed to implement performance measurement. CAI's global team helped identify key KPIs and built a two-level dashboard for tracking, analyzing, and reviewing results, ensuring alignment with site objectives before commercial production began.

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Blog

Reimagining Pharmaceutical Manufacturing: Why the latest E2500-25 Standard Revision Demands Immediate Action

September 5, 2025

Speed to patient is a primary driver behind the industry’s shift toward modern commissioning and qualification (C&Q) practices, while still ensuring product quality and...

E-Publication

Role-Based Talent Planning for Operational Readiness

September 3, 2025

As capital projects and technology transfers wrap up and facilities grow nearer to startup, site leaders and team members may be filled with a...

Blog

EU GMP Annex 1 Compliance: Global Requirements & PIC/S Alignment

August 21, 2025

The 2023 revision of EU GMP Annex 1 reset the global standard for sterile manufacturing. It expands the guidance, tightens contamination-control expectations and aligns...

Blog

WINDSOR FRAMEWORK: WHAT IS IT?

August 13, 2025

The Windsor Framework (WF), which came into effect on January 1, 2025, is a significant agreement between the UK and the EU that replaces...

Blog

CAI Appoints Jamie Robertson as Vice President of Mission Critical to Drive Innovation and Operational Excellence Across Global Infrastructure Projects

August 11, 2025

August 11, 2025 – Indianapolis, IN — CAI, a global leader in operational readiness and excellence for high-stakes, regulated environments, is proud to announce...

Case Study

Contamination Control: Generation of a Contamination Control Strategy

August 1, 2025

A small-scale parenteral nutritional compounding facility in Europe engaged CAI to support remediation efforts required by its local Regulatory Authority. The client site had...