ValConnect Innovation Day Princeton: A Glimpse into the Digital Future of Life Sciences
ValConnect Innovation Day Princeton brought Bayer, GSK, Cardinal Health, Transcat & Hansa Biopharma together to explore AI & Smart GxP™ in life sciences.
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How Integrating Risk Assessment and CPV Increases Patient Safety
May 16, 2024 10:00:00 AM | Integrating risk assessment and continued process verification with digital technology enhances patient safety and optimizes processes in the pharma industry.
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How Integrating Risk Assessment and CPV Increases Patient Safety
Integrating risk assessment and continued process verification with digital technology enhances patient safety and optimizes processes in the pharma industry.
Let's Move Beyond Spreadsheets for Risk Management
Discover why Excel is no longer sufficient for effective risk management in the pharma industry and why transitioning to specialized software is crucial.
Better Tech Transfers: A Digital Transformation Approach
Learn about rising drug development costs, the role of CDMOs, and how a digital-first strategy can revolutionize tech transfer in the pharma industry.
Digital Quality Risk Management: A ValGenesis Story
Learn about ValGenesis iRisk, an advanced tool for digital quality risk management, and its impact on vaccine development at a top biopharma company.
6 Ways to Make Your Risk Management More Effective
Improve the efficacy of your risk management process with these 6 strategies inspired by the ICH Q9 quality risk management guideline.
ICH Q12 Implementation: Enhancing PACM Agility
Explore the key aspects of ICH Q12 and a 5-step structured framework for effective post-approval change management (PACM) agility.
How Can You Simplify Regulatory Approval for PAC?
Learn how to simplify regulatory approval for post-approval changes and discover the benefits of implementing a PACM protocol and using a QRM platform.
Removing Bias from Risk Assessment
Discover how to leverage digital CPV to apply the ICH Q9 (R1) data-driven approaches and enable bias-free risk assessment in pharmaceutical manufacturing.
3 Huge Benefits of Integrating Process Data with Risk Management
In this post, we’ll look at 3 benefits of integrating process data with risk management and how it increases organizational efficiency and competitiveness.
Are You GMP Annex 1 Revision Ready?
Learn about the requirements of the Annex 1 revision and how to ensure compliance with a digital risk management platform.
It's Time to Implement ICH Q9(R1)
In this blog post we'll look into what steps you may need to take to make sure you are compliant with the ICH Q9(R1) guideline.
The 3 Types of Quality Risk Management Tools Used in Pharma
Explore the three types of quality risk management (QRM) tools in pharma and learn how to assess, prioritize and control risk across the product lifecycle.
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.
Is Analytical QbD the Future of Method Development?
This blog post will give you an overview of Analytical QbD and why it's important to implement it in your method development.
How to Align Analytical QbD With the new ICH Q14?
How to connect already existing AQbD with the new ICH Q14? Jean-François Dierick and Claudia Magagnoli from GSK explained us how!
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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
Catalent's Journey of Continuous Improvement for CSV Excellence
Are You Aligned with FDA's Computer Software Assurance Methodology?
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.
Cleaning Validation Limits Explained: HBEL/MACO, 10 ppm, and 'Visually Clean'
Explore the complexities of cleaning validation limits, including HBEL/MACO, 10 ppm, and visually clean to ensure patient safety and product quality.
Previously
Change Impact Assessments in ValGenesis iClean™: A Framework for Consistency
Unlocking Operational Capacity with Fully Digitalized Cleaning Validation
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