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. - 3.15 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

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.

Emmanuel Cansino

Senior Director Industry Solutions

11:00 AM

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.

Madhavi Ganesan

Director, KPMG Life Sciences Solutions Practice

11:45 AM

Networking Lunch

1:00 PM

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.

Pedro Ferreira

Quality and Risk Management Consultancy Service Lead

1:45 PM

Alkermes Initiates Modernization of Computer System Validation

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

Geetanjali Abbi

Director Digital Quality Assurance

2:30 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.

Hal Plant

Director of Sales

3:15 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