Welcome and Opening Remarks

CSA Adoption: Where we came from, where we are today, and what lies ahead

In this session, we will explore the origins of CSV, the challenges of CSV today and how it is difficult to scale with the changing quality landscape, and how CSA will change how we validate. At the end of the session, you will have a clear idea of the 6 Ts to CSA adoption which are important to consider when transforming your validation approach from CSV to CSA.

Data-Driven Risk Management: a Practical Approach to Minimize Subjectivity

ICH Q9(R1) introduced the need to manage and minimize subjectivity in risk management to enhance scientifically sound, risk-based decision making. In this presentation, we'll explore a practical approach in the context of a production process risk management.

Changing the Paradigm: Examining the Role of Quality - From Enforcement to Partnership

In an evolving digital landscape, that increases in complexity and its dynamic nature, the quality organization plays a key role in influencing innovative decisions. Despite its significance, the quality role is seen as a strict enforcer in many organizations. Let’s examine how to change your organization’s view of quality and its quality culture to make a lasting increase on your organization’s ROI.

Networking Lunch

Digitization of CSV: How Can You Get Ahead of the Curve and Implement CSA?

In this in-depth session, we'll cover computer software assurance (CSA) and why it is so important to life sciences. You'll learn the key differences between CSA and CSV as well as the key considerations to digitize your CSA and CSV processes.

Alkermes Initiates Modernization of Computer System Validation

Alkermes’ journey since launch of ValGenesis and our current and future roadmap

GxP 4.0 and the Power of Manufacturing Intelligence

Get an inside look at the ValGenesis product portfolio built to deliver comprehensive manufacturing intelligence to support your digital transformation initiatives.

Closing Remarks