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.
Latest News
Why QbD Breaks Down After Approval (and What Leaders Miss)
Mar 19, 2026 2:22:43 PM | Learn why Quality by Design (QbD) often fails post-approval and how pharma leaders can ensure decision traceability for continuous improvement and success.
All Blog Posts
Why QbD Breaks Down After Approval (and What Leaders Miss)
Learn why Quality by Design (QbD) often fails post-approval and how pharma leaders can ensure decision traceability for continuous improvement and success.
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.
Cell & Gene Therapies: is Quality by Design Ready for it?
In this blog post, we want to discuss about the application of the Quality by Design for Cell & Gene Therapies. Are they suited for them?
Developing a Retrospective QbD: a ValGenesis Story
A story about this time we helped a company in the Post-Approval Change Management of a Legacy Product using a Retrospective QbD methodology.
Developing a Drug Product Using QbD: a ValGenesis Story
This story is about our project with Libbs Farmacêutica to successfully apply a QbD framework in the development of an oral drug product
Cell and Gene Therapies: Risk Management Processes
In this blog post, we talk about how can you implement Risk Management Processes for Cell and Gene Therapies to every aspect of your product.
Accelerate Time-to-market Using a QbD Framework: a ValGenesis Story
We write about how we helped a company in accelerating the time-to-market of a drug product using a Quality by Design (QbD) framework
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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
4 Conversations to Drive Your Business Case for Digital Validation
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.
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Change Impact Assessments in ValGenesis iClean™: A Framework for Consistency
Discover how ValGenesis iClean™ standardizes change impact assessments in cleaning validation, enhancing consistency and compliance across teams and sites.
Previously
Unlocking Operational Capacity with Fully Digitalized Cleaning Validation
The Real Cost of Bottlenecks: Why Manual Cleaning Validation Increases Regulatory Risks
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