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, in-person event for GxP professionals.
24 May

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

@ Crowne Plaza San Francisco Airport

Request a Seat

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


10:00 AM

Welcome and Opening Remarks

10:15 AM

Different Perspectives for Implementation

Hear from Arnold Asuncion (Total Validation Services) for a perspective of Green Field implementation of ValGenesis VLMS as a pass-through SaaS approach for client companies to initiate qualification while simultaneously considering or implementing the ValGenesis platform themselves. Shawn Phillips (Genentech) will offer a perspective on implementing ValGenesis VLMS for an entire organization, while standardizing business processes along the way to meet long-term company objectives.

11:00 AM

Diving Into the Nexus of Life Sciences and Next-Gen AI

For life sciences, cyber, physical and biological technological advancements has made guided human therapeutics viable. But what if AI got ahold of it? Could ChatGPT generate protocols and run tests? Could an AI image generator produce objective evidence to support a regulatory filing? What about algorithms in Software as Medical Device (SaMD)? We'll explore what's real, what's artificial, and what matters.

11:45 AM

Building a Modern Biotech Company: The Advantages of a Digital-First Approach

Theragent, Inc. is a Cell and Gene Therapy CDMO focused on advancing next-generation cancer and rare disease treatments. Adopting a digital-first approach as a startup strategic objective, Theragent has eliminated all paper-processes which includes an electronic validation platform to reduce errors and gain efficiencies as a Pharma 4.0-ready connected plant. Join us to learn about the benefits of a digital-first approach and why it's critical for any organization, especially startups, as part of managing resources efficiently.

12:30 PM

Networking Lunch

1:45 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.

2:30 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.

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


24 May

Crowne Plaza San Francisco Airport

Crowne Plaza San Francisco Airport

1177 Airport Blvd
Burlingame, CA
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