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  3. AI Systems in Quality & Regulatory Affairs
AI Systems in Quality & Regulatory Affairs
Medical Devices
Combination Products
Artificial Inteligence

AI Systems in Quality & Regulatory Affairs

23 – 25 June 2026

Price available after dates are announced

TRAINING TIMES

  • 13:00 - 16:00Vienna
  • 12:00 - 15:00London
  • 07:00 - 10:00New York
  • 04:00 - 07:00Los Angeles
Online Training

WHY SHOULD YOU ATTEND?

Stay Ahead of the Curve

Understand how AI is transforming regulatory intelligence, submissions, and quality systems before it becomes the new compliance baseline.

Turn Automation into Advantage

Learn practical ways to integrate AI tools into QMS, audits, and documentation processes — saving time while improving consistency and oversight.

Decode Regulator Expectations

Gain insider insights on FDA and EU perspectives, ISO 42001, and emerging standards shaping the governance of AI in regulated environments.

Future-Proof Your Expertise

Build the competence and confidence to lead AI adoption in QA/RA roles, positioning yourself as a trusted voice in the next era of compliance and quality.


OUR ONLINE TRAINING EXPERIENCE INCLUDE

Two days of expert-led Zoom sessions packed with discussions, Q&As, and real-world scenarios.

All slides, tools, and supporting materials available in our CLIENT ZONE before, during, and after the course.

Receive a digital certificate (also Linkedin-ready) that verifies your skills in strategic trial planning.


LEARNING OBJECTIVES

Learning Objective

Evaluate Automation Opportunities

Assess how AI-driven tools can improve efficiency and consistency across compliance and auditing processes

Learning Objective

Understand AI Applications in QA/RA

Identify where and how AI technologies are transforming regulatory intelligence, submissions, and quality systems

Learning Objective

Interpret Regulatory Expectations

Understand FDA, EU, and ISO 42001 perspectives on the use and governance of AI in regulated environments

Learning Objective

Apply Risk and Governance Frameworks

Learn how to manage transparency, accountability, and ethical considerations in AI-enabled quality systems

Learning Objective

Leverage Data for Smarter Decisions

Use AI insights for trend detection, predictive audit planning, and risk-based prioritization

Learning Objective

Develop Future-Ready Skills

Strengthen the competencies needed to confidently lead AI adoption within regulatory and quality functions


WHO IS THIS TRAINING FOR?

Designed for professionals who want to enhance their expertise and advance their careers

Regulatory Affairs

Quality Assurance and Control

Device Engineering & Manufacturing

NB Reviewers


KEY TOPICS

Applying machine learning to enhance QMS processes and CAPA management
How AI transforms regulatory intelligence through automation and real-time insight
Leveraging predictive analytics for smarter, risk-based auditing and inspections
Ensuring governance, trust, and compliance with ISO 42001 and transparency principles
Developing the future-ready skills needed to lead AI adoption in QA and RA

TRAINER

James Pink

James Pink

Health Sciences and Medical Devices Consultant

James Pink has over 25 years of experience in the medical devices industry including 10 years as a healthcare technology expert and lead auditor for a leading European notified body. He began his career as a product designer in the oil tools industry moving into medical physics and clinical engineering at the Royal Hallamshire Hospital in Sheffield, UK. His industry experience includes managing product development and quality assuranceprograms for active and non-active implantable and combination products. James is a contributor to several medical device standards committees including ISO13485, ISO 14971 and various product-related standards.

Learn More →


TRAINING AGENDA

Training Agenda

AI Systems in Quality & Regulatory Affairs

Download the full training agenda to reveal complete session details, training takeaways, case studies, daily schedule, special features and full trainer bio.


TESTIMONIALS

“James provided practical and evidence supported materials that will help our team on next steps for implementing AI in our quality Systems”
Julie Underdahl
Principal Regulatory Affairs Specialist, AliveDX
“Truly appreciated the way and style of James' explanation, helped me understand more conceptually allowing easier digestion of a complex subject for a non-SME like myself. ”
AI Funaki
Director, Ambry Genetics
“James' balance of conceptual thinking connecting to real work use cases, specifics for the group was extremely helpful. ”
Anita Seidner
QA Manager / Deputy Responsible Person, Corza Medical