Welcome and Opening Remarks

Leveraging Agile principles and CSA to streamline your validation program

In this session, we will explore the latest guidance on CSA and how this new paradigm shift impacts our clients in the industry. We will delve into the concepts of CSA and Agile principles and how you are able to leverage them in your validation program and get you one step closer to Pharma 4.0.

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.

Integra LifeSciences Case Study: Digitalizing CSV

In this session, we will have an in-depth case study with Integra LifeSciences, covering the digitalization of a manual computer system validation process. We will review the reasons behind moving to a digital process, the difficulties faced, value added, and next steps for further improvement of the CSV process.

Networking Lunch

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.

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