Conference Agenda MOC
Every captured session in chronological order. Day one, 2026-09-15; day two, 2026-09-16; Raleigh, NC. Field notes Eric recorded between sessions are marked as such.
Day one (2026-09-15)
- Bill Gargano (RCM Data & Solutions), keynote - AI as force multiplier, validation moving from one-time event to continuous data process, FDA inspection priorities
- Panel: From Idea to Proof of Concept - Dori Gonzalez-Acevedo (ProcellaRX) moderating Tim Roy Kirkelie (Genari AI), Gaurav Walia (PQE Group), and Anant Agrawal (CIMCON Software) on POC hell, ROI framing, and human-in-the-loop
- Bharanitharan Rajendran (Validfor) - Reducing human risk in GxP: warning-letter statistics, six categories of human risk, five properties of defensible AI control
- Trust Is Not a Framework (Genari AI) - observability versus evaluation, LLM-as-judge qualification, golden sets with unhappy paths
- Shelly LaPointe - building a scalable, governable data estate for AI; agent identity as an access-control subject
- Ganesh Muralidharan (Vaisesika) - the AI pilot paradox, the sequencing diagnosis, the 5C framework, assist-augment-automate
- Abhishek Bachchan (Gilead) - defining acceptance criteria for AI validation: measurement systems, six acceptance-test buckets
- Field note: audit war rooms and mock audits - conversation with a regulatory-audit practitioner on how inspections actually run
- Field note: novel acceptance criteria via LLM - follow-up with Abhishek Bachchan on generalizing a grounded acceptance-criteria statement
- Ben O’Brien (Phanero) - intended use as the corporate governance foundation for GxP AI; four pillars and the domino effect
- Gaurav Walia (PQE Group) - turn quality metrics into action: quantified industry use cases, AI-driven CAPA, governance and validation
Day two (2026-09-16)
- Gaurav Walia (PQE Group) - aligning intelligent systems with FDA, EMA, and Annex 11/22 expectations; the regulators’ own AI tools
- Expert panel: AI misuse and regulatory actions - Abhishek Bachchan (Gilead) moderating Steve Ferrell (Valkit.ai), Madhavi Ganesan (PSC Biotech), and Joe Ault (Thermo Fisher Scientific)
- Vivekram Apparsundaram (Zifo) - modernizing internal audits: RADAR regulatory intelligence, governance dashboard, Part 11 assessment tooling
- Field note: vendor consultation - Eric evaluating an AI/LLM GxP validation platform: model cards, KPIs, golden datasets, the 48-hour validation claim
- Robert (Bob) Wherry (QACV Consulting) - ten steps to achieving AI regulatory compliance, from authorized-use policy to mock audit
- Binesh Prabhakar (One Vector) - twenty-four months of validating AI-assisted pharmacovigilance applications, told as lessons learned
- Field note: hallway conversation - GxP enforcement stories and Eric’s career arc from microbiology to clinical data science
- Carolyn Troiano (RiskCortex) - establishing continuous validation through real-time monitoring: playbook, coach, telemetry
- Panel: MVP for AI in GxP markets - Bryan Ennis (Sware) moderating Robin Stolzberg (Sapio Sciences) and Courtney Steele (DeepHow)
- Aarti (Amy) Arora (RxT), part 1 - strengthening AI systems with built-in cybersecurity and access control
- Aarti (Amy) Arora (RxT), part 2 - conclusion: four trust checks, the S.H.A.R.E. tabletop framework
- Yari Fontebasso (Systera Solutions) - from installation to validation: 113 local LLM experiments against GxP audit-trail review requirements