23 – 25 June 2026
13 – 15 October 2026
TRAINING TIMES
Understand how AI is transforming regulatory intelligence, submissions, and quality systems before it becomes the new compliance baseline.
Learn practical ways to integrate AI tools into QMS, audits, and documentation processes — saving time while improving consistency and oversight.
Gain insider insights on FDA and EU perspectives, ISO 42001, and emerging standards shaping the governance of AI in regulated environments.
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.
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.
Assess how AI-driven tools can improve efficiency and consistency across compliance and auditing processes
Identify where and how AI technologies are transforming regulatory intelligence, submissions, and quality systems
Understand FDA, EU, and ISO 42001 perspectives on the use and governance of AI in regulated environments
Learn how to manage transparency, accountability, and ethical considerations in AI-enabled quality systems
Use AI insights for trend detection, predictive audit planning, and risk-based prioritization
Strengthen the competencies needed to confidently lead AI adoption within regulatory and quality functions
Designed for professionals who want to enhance their expertise and advance their careers
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.
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“James provided practical and evidence supported materials that will help our team on next steps for implementing AI in our quality Systems”Julie Underdahl
“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
“James' balance of conceptual thinking connecting to real work use cases, specifics for the group was extremely helpful. ”Anita Seidner