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GMP

IPA’s 22nd Annual / 22e édition annuelle de l’IPA

GMP UPDATE
BPF Mise à jour

October 6–7, 2026 | Montréal, Canada

6–7 octobre 2026 | Montréal, Canada

Conference Topics at a Glance

  • Overview of HPIL Priorities and Activities, Including RTR Initiatives
  • How Much Quality Is Enough? When and How to Scale Your QMS During Clinical Development
  • From Documentation to Organizational Behavior: Building a Quality Culture Where People Speak Up, Learn, and Act
  • Risk Management and Risk Analysis
  • GMP Inspection Trends FY 2025-2026
  • USP Nitrosamines: Latest Developments in Risk Assessment, Analytical Challenges and Solutions
  • Understanding ICH Q3E Guideline for Extractables & Leachables
  • Cleaning Validation in 2026: Recurring FDA Findings and Practical Solutions
  • Contamination Control Strategies
  • Digitized Does Not Mean Integrated – Why the Future of Commissioning & Qualification (C&Q) Depends More on Project Delivery Excellence Than Validation Technology
  • Raw Material Transportation in the GMP Environment: A Risk-Based Framework for Product Quality, Compliance, and Supply Chain Resilience
  • Cost of Quality related to Second-Party Audits and Common GMP Audit Findings
  • Digital Transformation and AI Applications in Quality Management
  • Pharma Quality Expectations for AI/ML Solution Providers and AI GxP Validation Frameworks
  • Beyond AI: The Human Decisions That Still Matter in Pharma – Expertise, Accountability and Trust in the Age of AI
  • AI in GMP, Made Concrete 

Panel Discussions 

Potential Discussion Areas:

  • Drug shortages & supply continuity
  • CAPA & deviation investigations
  • Quality Management Review, management oversight & quality metrics
  • USP General Chapter <1058> – Analytical Instrument Qualification (AIQ)
  • OOS/OOT Investigations & Trending
  • Data Integrity in the QC Laboratory
  • Analytical Procedure Lifecycle Management — ICH Q14 / Q2(R2)
  • Microbiological Control, Sterility Assurance & Environmental Monitoring
  • Is traditional CSV/CSA sufficient for AI?
  • Data Integrity 2.0
  • AI-generated/AI-assisted data
  • Cloud and outsourced systems
  • AI supplier qualification
  • Human-in-the-loop

Have a Topic You’d Like to Add to the Panel Discussion?

We welcome you to submit any topics or questions you would like the panel to address. To help us prepare, please click here to share your suggestions in advance so that we can ensure the panel is prepared to address them

We will make every effort to incorporate all submitted topics into the panel discussion. However, due to the limited time available, we may not be able to address every topic submitted.

And so much more to come!

Note: Agenda & Topics is subject to change without prior notice, please check back regularly or contact us at enquiry@ipacanada.com for updates

Exhibitors & Sponsors

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