Published Articles - Tunnell Consulting

Quality Culture: Getting it Right the First Time

“Minimum viable product” may work well for software, but pharma needs to get it right the first time, and develop a culture of quality,

The key to successful technology transfer and facility startup is in strong project management, and it may make all the difference.

Biopharma needs to combine a “culture of quality” with value-added process improvements in manufacturing.

A well-constructed quality agreement can be an important tool to enable effective collaboration between owner and CMO.

By embracing efficiency and quality, biopharmaceutical organizations can work better and achieve better work.

Have FDA initiatives improved manufacturing quality and patient safety?

Understanding overall supplier capability versus the critical-to-quality attributes of your product can reduce both risk and cost.

October, 2012 – Lean may have been designed for manufacturing, but it can also transform quality control labs.

Unnecessary analytical testing can lead to unnecessary costs.

Focusing on how risk affects the entire organization can improve the business bottom line.

Are you factoring in the potential cost of unexpected failure?

Incorporating regulatory requirements into the product life-cycle plan is crucial for supply chain security and patient safety.