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...
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...
Read MoreReflecting Again on GMP Requirements for Marketing Authorization Holder
In July 2021, the European Medicines Agency (EMA) published their reflection paper entitled “Good Manufacturing Practice (GMP ) and the Marketing Authorisation Holder (MAH)”. This...
Read MoreState of Validation
CAI, Kneat Solutions, and others have partnered again in 2023 to conduct the annual State of Validation survey. The survey targets current professionals in a...
Read MoreBiotech’s QRM is All-Around Changes in the ICH Q9 Guideline
To foster greater success and reduce failure rates within the biotechnology industry, it has become imperative for companies to establish robust risk management plans. Quality...
Read MoreBiotech’s Compliance Odyssey: Navigating the Revamped EU GMP Annex 1 in the Age of Innovation and Accountability
In the dynamic world of biotechnology, where innovation is moving at a rapid pace and patient safety is paramount, compliance with regulatory standards is non-negotiable....
Read MoreSolving Drug Shortages With AI
Explore the positive impact of artificial intelligence (AI) on pharmaceutical manufacturing, addressing persistent drug shortages. Dive into the benefits of predictive analytics, quality control enhancements,...
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