Exclusive Event
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.
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.
Agenda
10:00 AM |
Welcome and Opening Remarks |
|
10:15 AM |
Leveraging Agile principles and CSA to streamline your validation programIn 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 CansinoSenior 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 GanesanDirector, KPMG Life Sciences Solutions Practice |
11:45 AM |
Networking Lunch |
|
1:00 PM |
Data-Driven Risk Management: a Practical Approach to Minimize SubjectivityICH 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 FerreiraQuality and Risk Management Consultancy Service Lead |
1:45 PM |
Alkermes Initiates Modernization of Computer System ValidationAlkermes’ journey since launch of ValGenesis and our current and future roadmap |
Geetanjali AbbiDirector Digital Quality Assurance |
2:30 PM |
GxP 4.0 and the Power of Manufacturing IntelligenceGet an inside look at the ValGenesis product portfolio built to deliver comprehensive manufacturing intelligence to support your digital transformation initiatives. |
Hal PlantDirector of Sales |
3:15 PM |
Closing Remarks |
Venue
The Conference Center At Waltham Woods

860 Winter Street
Waltham, MA
02451
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