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.
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.
Welcome and Opening Remarks
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.
Owner / President
Business Application Manager
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.
Senior Director Product Marketing
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.
Senior Validation Engineer
Principal Validation Engineer
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.
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.
Director, KPMG Life Sciences Solutions Practice
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.
Enterprise Account Executive
Crowne Plaza San Francisco Airport
1177 Airport Blvd
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