Conference Compendium

18th Annual Validation Week | IVT

IVT has been in the forefront of promoting good validation practice for the last three decades. Today, new global regulations, technology advances and industry case models have shaped how to develop, implement and deploy validation procedures company-wide. IVT's 18th Validation Week was a four-day event covering validation from A to Z, including; process, computer, equipment, method, facility, cleaning and much more.

Presentations include topics on:

  • Outlining new global regulations including FDA’s Process Validation Guidance
  • Streamlining the validation process
  • Developing a process validation roadmap
  • Developing acceptance criteria for process validation
  • Quality virtual networks and cloud computing.

Short Courses

  • Validation Week Bootcamp
  • Quality Control Lab Statistics for the Process Validation Guidance

General Sessions

  • Keep Up with Evolving FDA and Global Process Validation Guidance
  • The Impact of Current Regulatory Trends on Analytical Instrument Qualification
  • Understand and Overcome Challenges of Global Validation and GMP Regulations

Workshops

  • Incorporate Continued Process Verification and Continual Improvement into Your Validation Plan
  • Develop a Lifecycle Approach for Cleaning Validation
  • Establish Acceptance Criteria for Process Validation
  • A Roadmap to Computer System Development Lifecycle for GxP Systems

Sessions:

  • Equipment Qualification — Fit for Intended Use
  • Understand the Interface between the Quality Management System and Validation
  • Best Practice to Implement Process Validation in Drug Manufacturing Enterprise-Wide 
  • Best Practices to Implement Process Validation in Device Manufacturing Enterprise-wide
  • Lean Validation — Validation Cost Reduction
  • Construction of an Effective Validation Master Plan (VMP) — From Principles to Practice
  • Change Control and Configuration Management
  • Manage Risk in Cleaning Validation
  • Introduction to the Tools and Techniques of Auditing
  • Reduce Variability — Increase Production and Improve Quality and Compliance
  • Qualification of Virtual Network and Cloud Computing
  • Analytical Method Validation
  • Qualify Facilities, HVAC and Water Systems 
  • Role of Statistics in Process Validation
  • Conduct a Gap Analysis of a Validation Program
  • Implement Risk Management in the Validation Process
  • Standardize Validation Practices in a Global Organization
  • Prepare for and Handle FDA Validation Inspection
  • Validation Training — How Do I Do It?
  • Application of Quality by Design (QbD) Principles to Stability Validations for Combination Products — A Medical Device Perspective
  • Audit Vendors on Validation Practice
  • Strategies to Validate Computerized Legacy Systems

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