How Do the FDA's CSA Guidance and GAMP 5 Align?
Learn how ISPE's GAMP 5 Guideline and the FDA's CSA Guidance play complementary roles in ensuring the integrity and reliability of computerized systems.
Latest News
Business Continuity in Pharma: the Role of Risk Management
Mar 22, 2023 11:59:27 AM | Assuring business continuity in pharma can be complex. Effective risk management strategies can help you operate during disruptions.
Business Continuity in Pharma: the Role of Risk Management
Assuring business continuity in pharma can be complex. Effective risk management strategies can help you operate during disruptions.
QRM Over Lifecycle Management
Using QRM within a Lifecycle Management framework ensures consistency at all levels where modern pharma operations are concerned.
Tech Transfer: Planning for Success
Tech Transfer is especially important. When switching facilities, you want to transfer the knowledge and reproduce the process smoothly.
Cell and Gene Therapy: How to Minimize its Risks?
There are still some challenges when it comes to minimizing the risks in Cell and Gene Therapy. Here, we give some thoughts on how to manage and minimize them.
Biosimilars Approval: how to Reduce Time to Market?
In this blog post, we tell what the most effective approach for your biosimilars approval to reduce its time to market is.
Adopting Continuous Manufacturing (CM): The Case of Biologics
Continuous Manufacturing brings quality and delivery many business gains when applied to biologic products.
Cell and Gene Therapy: the Benefits of PAT and QbD
Cell and Gene Therapy products are considered the future of medicine. PAT and QbD can bring many benefits to C>
Digital Transformation: Impacting Global QRM
A blog post about applying digital transformation to the QRM of the top-tiers of the Pharmaceutical Companies and how it can benefit them.
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.
Medical Cannabis: the QRM Practices that Improve Your Business
A blog post where we give you some tips on how Quality Risk Management can help you improve your Medical Cannabis business
All Tags
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
Quality Risk Management
Risk and Data as Knowledge Enablers: a Lifecycle Approach - ValGenesis
Read the industry insight on the topic of Quality Risk Management
Presented by
Sandra Silva
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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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.
Best Practices for Impact Assessments in Cleaning Validation
Explore best practices for impact assessments in cleaning validation, including strategies for using technology to streamline the assessment process.
Previously
Five Cleaning Validation Challenges Digitalization Solves
Game-Changing Tech Paves Way for Better Cleaning Validation Outcomes
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.
The X Factor for Successful Digital Transformation in BioPharma: People
This current era of biopharmaceutical manufacturing is a most challenging and exciting time for our industry. Technology breakthroughs, intensifying competition, and continually rising ...
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