Published Articles

Tunnell’s subject matter experts have written a number of informative pieces. Here are a sampling of articles that have been published in leading industry publications.

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,

Integrating Technology Transfer and Facilities Startup for Biologics

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

Manufacturing’s True North: The Quality Compass

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

Quality Agreements for Contract Manufacturers

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

Operational Excellence: More Than Just Process Improvement

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

State of Quality and Compliance in the Biopharmaceutical Industry

Have FDA initiatives improved manufacturing quality and patient safety?

Connecting QbD, Knowledge Management and Supplier Quality Management

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

Through the Lens of Lean

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

Reduce Analytical Testing and Costs Without Compromising Compliance

Unnecessary analytical testing can lead to unnecessary costs.

Risk Based Decision Making

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

QbD: Time to Market

Are you factoring in the potential cost of unexpected failure?

Impact of cGMP on Supply Chain

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