Blogs
Business Centric Solutions for meeting Regulatory Requirements
Struggle with explaining Regulatory Requirements to upper management? Regulated industries have two masters: the regulators and CEOs; so why not develop strategic tools to serve both? Let’s use a process approach to determine how well your current practices meet your…
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Quality is not Overhead
Early in my tenure at a new organization, I encountered a telling moment that reflects a common mindset in healthcare and life sciences. Three days into the role, I met the CEO in the elevator and introduced myself. He immediately…
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Striving for perfection
For Quality Executives, one of the most consequential leadership challenges is knowing when to pursue improvement and when to recognize the point of diminishing returns. A lesson I first encountered in a high school geometry class captures this well. While…
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Tag you’re it…Supplier Quality
The childhood game of “tag” may be harmless fun, but in product development it often takes a far less productive form: shifting responsibility to vendors and suppliers. Product developers frequently hear explanations such as, “the vendor did not process the…
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What is Essential is Invisible to the Eye
For Quality Executives, communication is not simply about information transfer; it is about insight, context, and judgment. One of the enduring lessons from The Little Prince captures this well: “It is only with the heart that one can see clearly;…
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Developing Quality Relationships
For years, I have been mentoring a successful Quality/Regulatory friend who recently asked for guidance on dealing with personal relationships, focusing on his career and personal relationships. We discussed how we have established goals and requirements in our business lives…
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Plan Now Pays Later
Typically, initial planning neglects to account for potential failures in manufacturing, clinical testing, or handling post-marketing complaints. This oversight can lead to significant setbacks. Prioritizing planning for success over acknowledging potential setbacks isn’t the most optimistic approach; instead, understanding the…
Read MoreNot All Combination Products Are Created Equal: The Prefilled Syringe (PFS) Challenge
Prefilled syringes may seem straightforward: select a syringe, fill it with drug product, and contract out manufacturing, but in reality, PFS development is a complex endeavor. Regulatory agencies like the FDA are placing increased scrutiny on PFS-related combination products, citing…
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