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Planning for a Talented Workforce: Building a Staffing Plan for New or Expanding GMP Facilities
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Planning for a Talented Workforce: Building a Staffing Plan for New or Expanding GMP Facilities

Let’s contrast two very real scenarios: You are responsible for bringing a new GMP facility or line to full-scale production. Your board or shareholders expect...

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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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Emerging 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...

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Unlock 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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