Five Keys to Successful Facilities Management
Facilities Management is a critical aspect of maintaining a safe and efficient workplace. It involves a wide range of tasks, from maintaining the physical infrastructure...
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LESSONS LEARNED FROM IMPLEMENTING THE FDA’s CSA GUIDANCE: PART 1 – PLANNING
After several years of conversation with drug manufacturers and consultants about the state of computer system validation, the FDA issued a draft of the Computer...
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Remote Regulatory Assessments – Q&A: Here to Stay
On January 26, 2024, the Food and Drug Administration (FDA) provided notification of a revised draft guidance on Remote Regulatory Assessments (RRAs). The FDA has...
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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...
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FDA 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...
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The 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...
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The 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...
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Bridging 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...
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Challenges 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...
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CAI: 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...
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