Conference Compendium

21st Annual Validation Week

IVT's Validation Week is gold standard for the industry, and the 21st iteration of this flagship event was no different. Featuring speakers and delegates from the top of validation's fields, this conference was a hive of learning, idea sharing, and benchmarking. Read the agenda here.

Sessions include:

  • Process Validation—A Lifecycle Approach that Overcomes the Top Ten Validation Challenges
  • Introduction to Statistics in Lifecycle Process Validation
  • Implement Quality Risk Managment (QRM) into GMP and Validation Environments Enterprise-wide
  • Lifecycle Managment of Qualification and Validation—Implement EU's Annex 15 while Harmonizing with U.S. GMPs and Guidelines
  • Understand the FDA's Quality Metrics 2015 Guidance and the Effect on Validation—What You Need to Know!
  • Validation Sampling Plans and Acceptance Criteria
  • Challenges, Opportunities, and Strategies, for Green (Paperless) Validation
  • UnderstandDocumentation Requirements and Best Practices
  • DEVICE SPECIFIC: Develop a Successful and Comprehensive Road Map for Medical Device Process Validation
  • QUALITY SYSTEMS: Develop, Implement, and Maintain Effective Change Control in GMP and Validation, Environments
  • Implement a Risk-based Compueter and Software Validation (CSV) Program Company-wide
  • BioPharma Lifecycle Process Validation—Beyond the Basics
  • Detect and Control Validation
  • Validation Strategies for Shared Facilities—Manage Risk in Multi-product Manufacturing Areas
  • Validation Strategies for Aging Facilities
  • Audit Vendors on Validation Compliance
  • Validation Strategies for Aging Facilities
  • Data Integrity Validation
  • Develop a Remediation Plan for Equipment Validation Programs
  • Callibration in the Laboratory
  • Using QbD in Validation (ICH-Q8)
  • Continued Process Verification (CPV)—Maintain a Qualified State

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