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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QbD FAQs: Practical Answers for CMC Development
May 21, 2026 9:00:03 AM | Get clear answers to common QbD questions in CMC development, from QTPP and CQAs to design space, control strategy, digital QbD, tech transfer, and lifecycle management.
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QbD FAQs: Practical Answers for CMC Development
Get clear answers to common QbD questions in CMC development, from QTPP and CQAs to design space, control strategy, digital QbD, tech transfer, and lifecycle management.
Knowledge Management FAQs: Practical Answers on KASA, Data Integration and Knowledge Reuse
Get answers to common knowledge management questions in pharma, from tacit and explicit knowledge to KASA, digital infrastructure, and lifecycle reuse.
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Avoid Tech Transfer Delays: A Late-Stage QTTP, CQA, and CPP Mapping Guide
Learn what to capture in QTPP, CQA, and CPP mapping to prevent tech transfer delays and ensure late-stage readiness.
AQbD FAQs: Practical Answers to ATP, MODR, ICH Q14, and more
Get direct answers to common AQbD questions, from ATP and MODR to analytical control strategy, lifecycle management, and practical ICH Q14 implementation.
Why Spreadsheet-Based QbD Fails to Scale Across the Product Lifecycle
Discover why spreadsheet-based QbD quietly creates rework, risk, and delays—learn the five hidden costs and what to do instead.
Digitalizing QbD Frameworks: Setting Tech Transfers Up for Success
Digitalizing QbD frameworks enhances CMC development and tech transfer efficiency, transforming process knowledge into a strategic asset for faster manufacturing.
Why Manual QbD Leads to Delays, Errors, and Ongoing Frustrations
Manual QbD in pharma creates delays, errors, and frustrations. Discover how digital QbD frameworks enhance efficiency, accuracy, and compliance in drug development.
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How Spreadsheet Chaos Derails Quality by Design in Pharma
Learn how spreadsheet chaos undermines Quality by Design in pharma—and how digital QbD platforms support CMC manufacturing and development.
Building Control Strategies: It's Time to Go Digital
Discover the steps and benefits of digitalizing control strategies in pharma manufacturing to enhance compliance, efficiency, and product quality.
Digitalizing Pharma Control Strategies: A Roadmap
Transform pharma manufacturing with digital control strategies. Learn how to enhance product quality, streamline processes, and ensure regulatory compliance.
Better Pharmaceutical Development: A Case for ValGenesis iCMC
See how ValGenesis iRisk transforms pharmaceutical development by integrating QbD and AQbD, streamlining processes, improving quality, and expediting approvals.
How to Apply a Quality by Design Framework with ValGenesis iCMC
Learn how ValGenesis iCMC integrates Quality by Design principles with CMC lifecycle management to enhance pharmaceutical process development.
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.
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.
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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.
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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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