1. Eventura World
  2. Courses
  3. Production & Process Validation - Merging 820.75 with ISO 13485, and EU Annex 15

Production & Process Validation - Merging 820.75 with ISO 13485, and EU Annex 15

2-DAY DIGITAL EVENT

Two focused days dedicated to recalibrating production and process validation planning under evolving QMSR, ISO 13485, and global expectations. This seminar restructures Master Validation planning, risk integration, and DQ/IQ/OQ/PQ execution into a coherent, resource-conscious validation system.

Designed for leaders responsible for validation governance, risk integration, and cross-functional execution within regulated product lines.

⌛ 2 Days    |  ðŸ“…  March 16 - 17, 2026    |  ðŸ•’  Eastern Time US: 10 AM to 3 PM US     |  ðŸ•’  GMT: 2 PM to 7 PM


How This Session Is Structured

The seminar begins with regulatory shift and risk-driven planning principles, then builds toward structured Master Validation design. It progresses from planning architecture into applied protocol execution, integrating equipment, process, and software considerations. The second day reinforces disciplined implementation, ensuring validation activities align with ISO 14971 and global regulatory expectations without duplication or waste.

DAY 1: Risk-Driven Validation Planning and Master Strategy

  • Regulatory Shift to QMSR – How validation expectations have evolved
  • Why Validation Keeps Failing – Lessons from FDA observations
  • Risk-Based Validation Thinking – Integrating ISO 14971 into planning
  • Purpose of Master Validation Plan – Why FDA expects it
  • Building an Effective MVP – Structure, scope, and intent
  • Risk-Driven V&V Planning – Linking hazards to validation depth
  • Avoiding Costly Validation Waste – Fixing upfront planning gaps
  • Field-Tested Planning Examples – What works with regulators


DAY 2: Execution, Integration, and Global Alignment

  • Executing the Validation Plan – Turning strategy into action
  • DQ, IQ, OQ, PQ Usage – When and how to apply
  • ASTM E2500 Concepts – Efficient validation with limited resources
  • Validation Matrices Explained – Preventing overlooked requirements
  • Software Validation Expectations – FDA’s ten required documents
  • 21 CFR Part 11 Placement – Where compliance truly belongs
  • Cybersecurity and QMS Validation – Integrating without duplication
  • Global Validation Alignment – FDA, EU Annex 15, Asia


Course Director

John E. Lincoln

John E. Lincoln brings over four decades of experience in FDA-regulated industries, including extensive work in process, equipment, software, and QMS validations. His background in ISO 14971 risk management and global regulatory remediation supports in-depth, applied seminars that connect Master Validation planning with practical execution across U.S., EU, and Asian regulatory environments.


What Happens After You Reserve Your Seat

Your registration is managed by our events team to ensure a coordinated and seamless experience.

  • A confirmation email outlines onboarding details and next steps
  • Access credentials are shared in advance so you are prepared before the session
  • Handouts (where applicable) are provided ahead of time
  • The training is delivered live via Webex with interactive participation and Q&A
  • Certificates of completion are issued following the session
  • For live + recording access, post-session availability is provided through TalkFDA
  • Event support remains available for any access or logistics assistance