Implementing a Risk-based Approach to Calibration
How does your organization determine calibration test points, tolerances, and frequency? A simple rule of thumb to calibrate instruments at 10, 50, and 90% of...
Read MoreFDA Quality Management Maturity Program
Drug shortages in the pharmaceutical industry is a significant concern that has far-reaching consequences for the industry, the regulators, the healthcare system, and ultimately the...
Read MoreThe Readiness Stage of Technology Transfer
During a pharmaceutical technology transfer (TT) project, the Readiness Stage plays a pivotal role by establishing the groundwork for a successful transition. This phase involves...
Read MoreThe Future of FDA Regulatory Inspections:
The Office of Regulatory Affairs (ORA) at the U.S. Food and Drug Administration (FDA) is currently buzzing with activity and exciting developments. Here's a snapshot...
Read MoreBridging the Gap: Role Clarity, Skill Investment, and the Battle Against Drug Shortages
As advancements in medical science continue to expand the array of available treatments, the demand for pharmaceuticals has surged. This surge has caused an alarming...
Read MoreChallenges Implementing a Dark Factory in Biotechnology Manufacturing
The concept of a "dark factory" conjures images of secrecy and clandestine operations, but in the world of biotechnology manufacturing, it represents an innovative approach...
Read MoreCAI: Evolving Past Commissioning
In the dynamic world of life sciences, companies that embrace change and adapt to changing market needs are the ones that thrive. Our journey began...
Read MoreEmerging Therapeutics and Personalized Medicine
A Personalized Medicines Overview Personalized medicine, also known as precision medicine, represents a paradigm shift in healthcare, emphasizing the customization of medical treatments to individual...
Read MoreUnlock the True Potential of Project Management: Power Skills Edition
Introducing the Game-Changing Power Skills for Project Managers In today's fast-paced and ever-changing world of project management, technical expertise alone is no longer enough. The...
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