Artificial Intelligence in FDA-Regulated Manufacturing: From Foundations to Implementation
This intensive hands-on workshop bridges the gap between AI capabilities and regulatory reality in life sciences manufacturing. Participants will gain practical knowledge of how large language models work, learn to design AI systems appropriate for GxP environments, and develop validation strategies that satisfy regulatory expectations. Through a combination of instruction and collaborative design workshops, attendees will create a complete AI system implementation plan for their own use case—leaving with actionable frameworks and a roadmap they can present to their organizations.
Designed specifically for quality, regulatory, and technical operations professionals in pharma and biotech, this course cuts through AI hype to deliver pragmatic guidance grounded in real manufacturing experience and actual regulatory deployments.
| Dates | Course | Cost | Registration |
|---|---|---|---|
| May 12-13, 2026 | Artificial Intelligence in FDA-Regulated Manufacturing: From Foundations to Implementation | $1,500 | Register |
| May 20–21, 2026 | Hands-On Essentials of Automation for Biomanufacturing | $2,050 | Register |
| May 27–29, 2026 | Preparative Chromatography Column Packing: Lab to Process Scale | $2,500 | Register |
| June 3–4, 2026 | Applied Cleaning Validation Practices: A STERIS Master Class | $2,000 | Register |
| June 9–10, 2026 | Introduction to Biopharmaceutical Lyophilization | $1,975 | Register |
| June 11, 2026 | Essentials of Spray Drying and Powder Analysis | $995 | Register |
| June 16–18, 2026 | Fundamentals of Mammalian Cell Line Development | $3,100 | Register |
| June 23–25, 2026 | Biopharmaceutical Assay Essentials | $3,100 | Register |
| June 23–25, 2026 | Fermentation Engineering | $3,100 | Register |
| June 30–July 2, 2026 | Hands-On Principles of mRNA Technology | $2,500 | Register |
| July 8–10, 2026 | Downstream Biopharmaceutical Processes: Fundamentals and Design | $3,100 | Register |
| July 14–16, 2026 | AAV Quality Attributes: Theory and Practice | $2,975 | Register |
| July 14–17, 2026 | Hands-On cGMP Biomanufacturing Operations | $4,200 | Register |
| July 28–31, 2026 | Hands-On Biomanufacturing of Vectors for Gene Therapy | $4,500 | Register |
| Aug 6, 2026 | Design of Experiments for Biomanufacturing | $500* | Register |
| Sept 29–Oct 1, 2026 | Cell Culture Engineering | $4,200 | Register |
| Oct 13–16, 2026 | Applied Principles and Techniques of Depth Flow Filtration (DFF) and Tangential Flow Filtration (TFF) for BioPharm Purification | $3,995 | Register |
| Nov 10–12, 2026 | PAT for Real-time Culture Monitoring and Closed-Loop Process Control | $2,975 | Register |
| November 12-19 | Microbial Contamination Control in Bioprocessing Operations | $2,975 |
Register by 12 p.m. EDT on Friday, May 8
Attend and You Will Learn
By the end of this workshop, participants will be able to:
- Explain how large language models generate outputs and why probabilistic behavior matters for regulated applications
- Design system architecture appropriate for GxP environments (model selection, data strategies, control points)
- Develop validation strategies using risk-based frameworks (GAMP5, FDA CSA) tailored to Context of Use
- Apply data governance principles that maintain ALCOA+ integrity for AI systems
- Interpret current FDA, EMA, and EU regulatory expectations for AI in life sciences
- Create system prompts with appropriate guardrails and human oversight controls
- Construct implementation roadmaps including validation, governance, and risk mitigation strategies
- Evaluate AI vendor capabilities and build vs buy decisions for your organization
Who Should Attend
- Quality Assurance/Quality Control professionals
- Regulatory Affairs specialists
- Manufacturing and Technical Operations leaders
- Validation engineers
- IT and Digital Transformation teams
- Anyone evaluating or implementing AI in regulated environments
Prerequisite
Basic understanding of GMP/GxP concepts. No prior AI or programming experience required.
What You’ll Take Away
- Comprehensive slide deck covering AI fundamentals through regulatory compliance
- AI system design documentation for your own use case (architecture, data strategy, validation approach)
- Implementation roadmap ready to present to your organization
- System prompt examples you’ve written and tested (using provided LLM access)
- Regulatory reference guide (FDA, EMA, EU AI Act requirements)
- Vendor evaluation checklist for assessing AI solutions
- Email access to instructor for follow-up questions
Instructors
Chris Dayton is Co-Founder and CEO of QualityAssured.ai, where he builds inspection-ready AI systems for pharmaceutical and biotech manufacturing.
Chris spent nearly a decade in pharma manufacturing operations, progressing from production associate to leadership roles including Head of Upstream Process and Head of Technical Operations. He’s managed GMP facilities, navigated inspections, and dealt with the operational reality of pharmaceutical quality systems, experience that now informs how he designs AI for the industry.
This dual expertise, manufacturing leadership and AI system architecture, allows Chris to bridge the gap between what AI can do and what actually works in regulated environments. He designs AI platforms built to meet regulatory requirements, develops validation strategies aligned with GAMP 5 and FDA CSA frameworks, and helps quality teams implement AI with comprehensive compliance controls.
Chris specializes in making AI inspection-ready for GxP environments: air-gapped architectures, risk-based validation frameworks (GAMP 5, FDA CSA), and data governance that meets ALCOA+ principles. Through QualityAssured.ai, he’s helped pharmaceutical companies implement AI across quality operations: deviation and CAPA analysis, regulatory gap assessment, SOP authorship and review, audit response preparation, and risk management tools including FMEAs.
Why Chris teaches this workshop: Most AI training is taught by data scientists who’ve never worked in GMP, or by quality professionals who don’t understand AI architecture. Chris has done both—and knows what it takes to deploy AI systems that regulators accept and manufacturers can actually use.
Adam Pinkert
Senior Advisor: Quality and Regulatory – Quality Assured AI
Adam Pinkert is a senior Biotech quality consultant and executive with 30+ years of experience in compliance, FDA remediation, quality systems implementation, and regulatory strategy. Adam has a proven track record leading inspection readiness, supplier quality management, biotech/CGT operations, and aseptic manufacturing from Phase I through commercial launch. Adam has held senior leadership roles at Resilience, ADMA Biologics, Roche, and Genentech, where he drove regulatory approvals, developed scalable Quality Management Systems (QMS), and introduced lean processes. His expertise includes regulatory/PAI readiness, quality audits, CMC authoring and submission, quality risk management, contamination control, data integrity, tech transfers, and CDMO/CRO oversight, helping companies achieve inspection success and operational excellence.