Pre-Conference Workshop Day

Tuesday, September 5, 2023

Workshop A | 9.00am - 11.00am | A Practical Guide to Maintaining Digital Validation in the Life Sciences Industry

Too often, validation becomes a barrier to innovation in life sciences because of the time and resources required. However, validation and compliance impact the success of the entire company, and prioritizing digital validation is key to a robust transformation strategy.

In this workshop you’ll hear from colleagues who will share how putting validation at the forefront has resulted in working better, smarter, and more efficiently.

Join this workshop to learn about:

  • Dismantling organizational silos and empowering the exchange of information
  • Distributing the responsibility of compliance across the organization
  • Limiting resource constraints for harmonization across teams and workstreams

Workshop Leader:


Bryan Ennis
CEO & Co-Founder

Workshop B | 11:30am - 1:30pm | Applying Critical Thinking to Compliance & Business Capability

GAMP® 5 Second Edition strongly emphasizes the need to apply critical thinking within the scope of engineering and compliance activities. Beyond the system and the application, critical thinking should be the enabler to consider the data, application, and system in wider scope covering the supported processes in their entirety.

Join this workshop to learn about:

  • What the extent and impact of critical thinking are and what it really means
  • The need for rigor and a systemic approach to securing efficiency and consistency
  • How to plan, perform and report critical thinking through system and data life cycles

Workshop Leader:

Yves Samson

Yves Samson
Director and Founder
Kereon AG, Basel
ECA Data Integrity & IT Compliance Group 

Workshop C | 2:30pm - 4:30pm | This is Not Your Grandmother’s Validated State: What Medical Device Functions Running in the Public Cloud can Teach the World of GxP

The tech vendors creating cloud and other modern computing technologies continually impress us with the speed of their endless upgrades. However, this non-stop approach to platform enhancement isn’t readily compatible with MedTech’s traditional approach to regulated change management. This is especially relevant since these cloud-based regulated software functions are being placed on public cloud computers that are not under the direct control of the companies hosting and using the systems.

We can’t ignore this contradiction and hope it just goes away. Instead, we need to adapt to a new set of architectural approaches, best practices, and systems thinking, and embrace a more modern approach to systems safety and the meaning of the validated state. By shifting to a new paradigm, companies that make and use regulated software systems in MedTech and the life sciences, the regulators that oversee them, and the providers and patients that use them can all be more confident that the systems we all depend on are state-of-the-art, reliable, safe and effective.

Join this workshop to learn:
• About the first-ever guidance around this topic – AAMI CR:510(2021) and the in-process AAMI TIR115. Also, via a hands-on case study format, analyze the potential application of the public cloud to software regulated under GxP and/or 13405/62304.
• An overview of the opportunities and challenges facing MedTech and life sciences as we incorporate the cloud and other modern computing technologies into our regulated software systems.
• An overview of a new, industry-consensus-based framework that stakeholders in our industry (including cloud computing services providers) can use to start thinking about smart approaches to appropriately seizing new technology-enabled opportunities while still responsibly mitigating risks.

Workshop Leader:

Randy Horton
Co-Chair of Cloud Working Group and Technical Information Report

Cabell Maddux

Cabell Maddux
Director of Software Engineering
Day Zero Diagnostics