Validation, Commissioning & Design White Papers & Case Studies
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Advancing Compliance And Digital Strategy To Align With Pharma 4.0
11/21/2023
AmplifyBio sought to identify areas of its operation where digitalization could yield ROI in a short amount of time. Gain insight into the out-of-the-box solution that aligned with Pharma 4.0.
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Reliability Assessments And Benchmarking In Life Sciences
11/7/2023
Gain insight into how a prominent medical device manufacturer observed a significant improvement in its plant-wide OSHA recordable rate and cost of goods savings of over $100,000/year in just one year.
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The Role Of The Technical Transfer Executive Sponsor
10/30/2023
Explore the importance of understanding a CDMO’s flexibility and culture, models and scale of equipment, technical capabilities, regulatory support, quality system, and executive sponsorship model.
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Regulatory And Quality Consulting, Operational Readiness Services
10/5/2023
Learn how CAI aided a manufacturing company in merging food regulations with biopharmaceutical technology, allowing for the quick conversion of a small R&D facility into a GMP-compliant facility.
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Meeting An Aggressive Go-To-Clinic Timeline
9/27/2023
Finding an outsourcing partner capable of giving your company proper attention and meeting project milestones on schedule is crucial to ensuring patients in need receive treatment in a timely manner.
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Driving Efficiency In QC Labs
9/21/2023
Here, we examine the cause and impact of common errors in Quality Control (QC) labs, the strategy for reducing those errors with an intuitive chromatography system, and more.
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CAPA Management Improvement Process
9/15/2023
Gain insight into how a small team of experts worked to collect, trend, and understand the CAPA generation and completion process of a client struggling with on-time batch release, missed CAPA closure deadlines, and more.
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Could RFID-Based Unit-Level Traceability Be Key To Operational Excellence?
9/5/2023
Radiofrequency identification (RFID)-based unit-level tracking solutions for prefilled syringes are poised to help pharma manufacturers address key risks and costly bottlenecks related to the fill-finish process.
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Sterile Filtration And Quality Risk Management
8/31/2023
Process control is essential for manufacturing sterile products. Explore the role of filtration for bioburden control in quality risk management and contamination control strategies.
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Intro To USP <1062> - What It Is And Why You Should Use It
7/20/2023
Knowing how to use USP <1062> helps manufacturers manage the wide variety of factors that can exacerbate production costs, or result in no product at all.