Guest Columns

1. Process Validation: Optimizing Operational Excellence In Pharma And Medical Devices 7/3/2025

   Process validation is often viewed as a costly regulatory formality. However, it is actually a strategic investment that, when integrated into business planning, delivers measurable outcomes in productivity, compliance, speed-to-market, and profitability.

2. Cleaning Process Capability: Risk-Based Cleaning Process Performance Qualification 7/1/2025

   A cleaning validation professional must know how many process performance qualification runs are necessary. Here's how to go about demonstrating this with a high degree of assurance while minimizing the number of qualification runs.

3. Navigating FDA Regulatory Changes: Policy Shifts, Deregulation, Restructuring, And Future Oversight 6/23/2025

   Recent shifts within the U.S. FDA reflect an increasingly complex tension between scientific rigor and accelerating political and economic pressures. Here are the newest developments and emerging focal points.

4. How Is RIM Software Transforming Regulatory Compliance? 6/20/2025

   Regulatory information management (RIM) software tools streamline global regulatory processes on a single cloud-based platform throughout the entire product life cycle.

5. What To Expect When You Move Into Production For The First Time 6/17/2025

   In medical device development, things don’t go quite as you planned the first time around. This article shares what to really expect when you take your device into manufacturing.

6. Key Regulatory Landscapes For SaMD Around The World 6/13/2025

   As the use of medical device software and software as a medical device (SaMD) grows, regulatory bodies around the world are evolving to keep pace.

7. A Look At Elsa, The FDA's New AI Digital Assistant 6/12/2025

   The U.S. FDA recently launched its very own generative AI tool called Elsa. It's designed to assist FDA employees across various functions, from scientific reviewers to investigators.

8. Bracing For The Impact Of The Federal Workforce Reduction 6/9/2025

   The federal workforce reductions pose significant challenges for the life sciences industry, particularly for R&D, supply chain oversight, and industry workforce development.

9. Neuromodulation Dominates The U.S. Market For Neurological Devices 6/6/2025

   Neuromodulation devices are used to manage conditions such as chronic pain, neurological disorders, epilepsy, and more. New market research shares U.S. market trends.

10. Cleaning Process Capability: Understanding Populations, Samples, And Sample Size Requirements 6/6/2025

    This article examines the role of sample sizes in the determination of cleaning process capability or process performance in the manufacture of drugs/therapies and medical devices.