ARTICLES BY KEVIN WALL
How To Stop Fighting Quality Fires Using Quality Risk Management3/23/2020
Do you like fighting quality fires? Do you enjoy generating meaningless metric reports that no one acts upon? Do you get the most from your quality risk management (QRM) program? This article provides three practical steps for integrating QRM into your quality system to ensure your organization stays on course.
3 CMC Mistakes That Could Cost You Billions2/24/2020
The end game for many small biotech startups is acquisition by Big Pharma. While CMC may not add zeros to the sales price, poorly documented development can remove them. These three due diligence keys can help preserve your company valuation.
Choosing A CDMO: If You Can’t Answer 'Yes' To These 3 Questions, Walk Away1/30/2020
Choosing the right CDMO is the most important factor in the success of drug product and process development, particularly for small and virtual companies. To choose the right CDMO, you must look past the opening presentation, the facility walk-throughs, and even the compliance audit.
When Should Formal Quality By Design Documentation Begin?12/23/2019
When is the best time to start quality by design (QbD)? This question is asked most frequently among many small firms. A better way to phrase it is: When should I formally document my QbD activities?
Debunking The Top 3 Myths About Quality By Design (QbD)11/8/2019
Pharmaceutical QbD and quality risk management principles have become mainstays, but prevalent myths stymie adoption of the concepts. Dismantling those myths enables more companies to capitalize on the benefits of QbD.