ICH Q13: Everyone Talks About Continuous Manufacturing. Almost Nobody Talks About the Batch.
When people first hear the term continuous manufacturing, they often assume that batches disappear. After all, if material is continuously entering a process and product is continuously leaving it, what exactly constitutes a batch? Surprisingly, one of the most important messages in ICH Q13 is that continuous manufacturing does not eliminate the need for batches. […]
Audits and Self-Improvement: Lesson’s From Peter Drucker on Quality in Combination Products, Medical Devices, Pharmaceuticals and Life
In this episode of Let’s ComBinate, we dive into the fascinating world of audits—a cornerstone activity for ensuring quality, compliance, and continuous improvement across industries. Whether you’re managing combination products, medical devices, or pharmaceuticals, audits are critical for assessing systems objectively and identifying opportunities for growth. As the year draws to a close, I reflect on my own tradition […]
Should You Study Bioengineering in 2025? Insights from a Decade in Pharma and Medical Devices
Choosing a college major is one of the most significant decisions you’ll make in shaping your future career. For many, bioengineering stands out as a promising path, blending cutting-edge innovation with the potential to make a meaningful impact on people’s lives. But is it the right choice for you? In this blog post, based on […]