CSV and CSA FAQs: Practical Answers for Life Sciences Validation Teams
Get practical answers about CSV, CSA, risk-based testing, assurance needs, documentation, requirements, and ValGenesis support for software validation.
Latest News
Finding the Root-Cause in a Process: a ValGenesis Story
Apr 20, 2023, 10:37:17 AM | A light story about how ValGenesis joining on a quest to finding the root cause of a deviation in a process, how did we do it and what came of it.
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Finding the Root-Cause in a Process: a ValGenesis Story
A light story about how ValGenesis joining on a quest to finding the root cause of a deviation in a process, how did we do it and what came of it.
Finding a Root-cause in a Filter Clogging at Drug Product Filtration
This time we tell you how we helped a company finding a root-cause in a Filter Clogging and how we solved it.
Finding the Root Cause in mAB Production: a ValGenesis Story
Learn how we helped a customer find the root cause of a problem in monoclonal antibody (mAB) production and become stronger.
Optimizing a Perfusion Cell Culture: a ValGenesis Story
This is a post about optimising a perfusion cell culture, using a combination of Root Cause Anlysis and Corrective and Preventive Action.
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Featured Content
Quality Risk Management
Finding the Root Cause in mAB Production: a ValGenesis Story
Learn how we helped a customer find the root cause of a problem in monoclonal antibody (mAB) production and become stronger.
Written by
Sofia Santos
Tech Transfer & Process Scale-up
How to Accelerate Process Scale-Up With Effective Tech Transfer
There's a need to accelerate pharma product development and process scale-up. Having an effective tech transfer strategy can help you.
Written by
Sofia Santos
Cleaning Validation
Risk-Based Cleaning Validation: A Lifecycle Approach
Explore the evolution of pharmaceutical cleaning validation from compliance-focused practices to a risk-based, lifecycle-driven approach.
Written by
Kenneth Pierce
CSV and the Shift to CSA
CSA flips the paradigm of traditional CSV to "right-size" validation processes. Learn more about the benefits and principles of the CSA approach, which encourages critical thinking and automation.
Previously
ValConnect Innovation Day Princeton: A Glimpse into the Digital Future of Life Sciences
Catalent's Journey of Continuous Improvement for CSV Excellence
Cleaning Validation
Learn how digitization offers a consistent way to carry out cleaning validation lifecycle activities, ensuring your methods and procedures are risk-based and rooted in scientific evidence.
Reducing Over-Validation Through Worst-Case Selection
Learn how worst-case selection in cleaning validation can optimize efforts, reduce redundancy, and ensure safety in multiproduct pharma facilities.
Previously
Cleaning Validation in Pharma: FAQs on Limits, Risk, and Control
Dirty and Clean Hold Times: Setting Defensible Limits for Cleaning Validation
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