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Blog

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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

Comparability for Post-Approval Changes

Apr 20, 2023 9:52:47 AM | Today we want to take a fresh look into comparability for post-approval changes. How? We're thinking of a unique multiparametric approach.

Comparability for Post-Approval Changes

Today we want to take a fresh look into comparability for...

Finding a Root-cause in a Filter Clogging at Drug Product Filtration

This ValGenesis story is about how we helped a company...

Cleaning Validation Stage 1: On a Quest for Process Understanding

The key to control for any process resides in understanding...

Bioequivalence Studies: how to Streamline Generic Drug Approval Process

Generic products can be safe, effective, and lower cost...

Manual CPV vs Digital CPV: Why Should you Upgrade?

In our last blog posts about Continued Process Verification...

Computer Software Assurance (CSA): What are Assurance Needs?

This is the third post in a series of five summarizing a...

ValConnect 2022 – Day Two Round-Up

 

Welcome to day two of ValConnect 2022! We’re halfway...

6 Reasons Validation Projects Fail

Life sciences companies are under increasing pressure to...

Featured Content

Finding the Root Cause in mAB Production: a ValGenesis Story

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.

Sofia Santos

Written by
Sofia Santos

How to Accelerate Process Scale-Up With Effective Tech Transfer

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.

Sofia Santos

Written by
Sofia Santos

Risk and Data as Knowledge Enablers: A Lifecycle Approach

Quality Risk Management

Risk and Data as Knowledge Enablers: a Lifecycle Approach - ValGenesis

Read the industry insight on the topic of Quality Risk Management

Sandra Silva

Presented by
Sandra Silva

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

Your Guide to Computer Software Assurance (CSA)

FDAs Computer Software Assurance (CSA) – Part 3 of 3

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

Maximize the Use of Technology to Access Real-Time Clean In Place Data

Cleaning Validation Stage 1: On a Quest for Process Understanding

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.

Previously

The Pharma 4.0 Vision for Manufacturing Intelligence

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