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Welcome to the ValGenesis blog, your resource for timely insights from industry-leading experts on the trends, best practices, and new technologies impacting the life sciences.

Latest News

ICH Q12 Implementation: Enhancing PACM Agility

Nov 30, 2023 2:12:33 PM | Explore the key aspects of ICH Q12 and a 5-step structured framework for effective post-approval change management (PACM) agility.

All Blog Posts

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.

Comparability for Post-Approval Changes

Today we want to take a fresh look into comparability for post-approval changes. How? We're thinking of a unique multiparametric approach.

Creating a Post-approval Change Management (PACM) Protocol

In this blog post, we will give you all the steps about how to create a PACM protocol and how ICH Q12 supports you in it.

Featured Content

Finding the Root Cause in mAB Production: a ValGenesis Story

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.

Sofia Santos

Written by
Sofia Santos

How to Accelerate Process Scale-Up With Effective Tech Transfer

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.

Sofia Santos

Written by
Sofia Santos

Risk-Based Cleaning Validation: A Lifecycle Approach

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.

Kenneth Pierce

Written by
Kenneth Pierce

Trending Topics With ValGenesis Customers

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.

Previously

Unlocking Operational Capacity with Fully Digitalized Cleaning Validation

The Real Cost of Bottlenecks: Why Manual Cleaning Validation Increases Regulatory Risks

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.

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