Exclusive Event

Critical Thinking with Risk-Based Validation, presented by ValGenesis

Join us for a one-day special event to explore advances in quality risk management, computer software assurance, and cutting edge technology like AI. This is a free event for GxP professionals.
08 June

10.00 a.m. - 4.00 p.m.
(includes a networking lunch)

@ The Conference Center At Waltham Woods

Request a Seat

This is an in-person event and seating is limited.


10:00 AM

Welcome and Opening Remarks

10:15 AM

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.

11:00 AM

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.

11:45 AM

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.

12:30 PM

Networking Lunch

1:45 PM

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.

2:30 PM

Alkermes Initiates Modernization of Computer System Validation

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

3:15 PM

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.

4:00 PM

Closing Remarks


08 Jun

The Conference Center At Waltham Woods

The Conference Center At Waltham Woods

860 Winter Street
Waltham, MA
United States

Why Attend?

Networking opportunity with your peers

Learn how CSA flips the paradigm of validation

Discuss how the Pharma 4.0 framework affects risk management

See how to achieve a state of readiness and maturity that drives the manufacturing vision of the future in keeping with Pharma 4.0