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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
Digitalizing Pharma Control Strategies: A Roadmap
Sep 12, 2024 10:14:00 AM | Transform pharma manufacturing with digital control strategies. Learn how to enhance product quality, streamline processes, and ensure regulatory compliance.
All Blog Posts
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.
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.
Build an Effective Data Integrity Program with Risk Management
Understand why data integrity problems occur, and learn how to build an effective, risk-based corporate data integrity program to address them.
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.
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.
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 and What They Do Best
This post highlights the benefits and limitations of 3 types of QRM tools (simple brainstorming tools, simple risk analysis tools, and complex risk classification tools) and provides suggestions for their ideal application.
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?
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.
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!
How to Design a Control Strategy for Analytical Procedures
An efficient control strategy will ensure your processes performs always as expected. In this blog post we described the steps to design one.
Risk Management for Medical Devices
Many medical device companies have struggled with implementing a risk management process that results in risk being mitigated to the level of AFAP.
New ICH Q14 Guideline: key Implementation Aspects
The ICH released a draft version of the new ICH Q14 Guideline last March. This blog post will give you an overview of its key implementation aspects.
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Featured Content
Root-Cause Analysis
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
Process Digitalization
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
The Benefits of Automating Your Requirements Traceability Matrix
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.
Unlocking Operational Capacity with Fully Digitalized Cleaning Validation
Discover how fully digitalized cleaning validation boosts efficiency, ensures compliance, and transforms operational capacity in pharmaceutical manufacturing.
Previously
The Real Cost of Bottlenecks: Why Manual Cleaning Validation Increases Regulatory Risks
Digital Cleaning Validation: From Lifecycle Control to Real-Time Assurance
Pharma 4.0
Waves of new technology and thinking — IoT, AR, cloud, Agile — are transforming the very foundation of validation processes. Learn how to leverage them in a Pharma 4.0 world.
Unlocking Operational Capacity with Fully Digitalized Cleaning Validation
Discover how fully digitalized cleaning validation boosts efficiency, ensures compliance, and transforms operational capacity in pharmaceutical manufacturing.
Previously
Catalent's Journey of Continuous Improvement for CSV Excellence
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