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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Reflecting 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...
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State 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...
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Compliance: Framing Success Utilizing PIC/S and EU GMP
Introduction PIC/S was founded in 1995 as an extension of PIC (Pharmaceutical Inspection Convention). They are a non-binding cooperative arrangement between 56 different Regulatory Authorities....
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Biotech’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...
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Biotech’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....
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Solving 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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Revolutionizing Drug Manufacturing: A closer look at pending Facility Applications for GMP Inspections
COVID-19 pandemic exposed vulnerabilities and challenges in pharmaceutical supply chains, leading to drug shortages and disruptions. Whilst certain aspects of the pandemic have gone away,...
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