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October 14–16, 2020
San Diego, CA

Pragmatic Approaches for Achieving Regulatory Compliance and Ensuring Quality

The gold-standard event for validation and quality professionals across the life sciences, providing critical information on new regulations, technology advances and industry best practices.

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Register by June 19, 2020 and Save $300!

What to Expect in 2020

Practical Expertise and Risk-Based Approaches to Validation
  • Integrate Quality-by-Design Lifecycle into Process Validation, Qualification and Quality Systems
  • Develop a Strategic Lifecycle Approach to Validation and Risk Management
  • Leverage Data Integrity Audits to Eliminate 483s and Warning Letter Observations
  • Pragmatic Approaches to Third-Party Risk Management and Validation Oversight
  • Identify Key Learnings and Common Roadblocks to Ensure Successful Audits
  • Practical Approaches to Supply Chain Validation and Verification
Driving Innovation and Ringing in a New Era of Quality and Validation
  • Explore the Convergence of Global Regulatory Trends Impacting Quality Management
  • Assess the Paradigm Shifts in Early Phase Bio/Pharmaceutical Manufacturing
  • Compliance Factors for Cloud Validation
  • Mastering Automated Validation Testing — Principles and Best Practices
  • Advanced Therapy Medicinal Products (ATMPs) — A Journey into Uncharted Territory
Empowerment, Diversity and Inclusion Summit — Paving the Way for Progress in Validation
  • Discuss the challenges and experiences of women advancing their careers in quality
  • Reflect on ways to elevate diversity and inclusion in internal teams
  • Past Discussion Leaders Include:

Connie Hetzler, Global Validation Head, Alcon Labs

Lizzandra Rivera, Assistant Director, Quality – Systems, Standards & Compliance, CSV Program Manager, Alexion

Valerie King-Bailey, CEO, OnShore Technology Group

Kimberly A. Trautman, MS., Executive Vice President Medical Device International Services, NSF Medical Devices

Michelle Hickey, Director, Validation, Clovis Oncology