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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.

Take Advantage of our Advanced Pricing Discount...

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