Conference Compendium

19th Annual Validation Week | IVT

Validation Week is 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. Validation Week is a three-day event covering validation from A to Z, including; process, computer, equipment, method, facility, cleaning, and much more.

Topics included in the 19th Annual Validation Week compendium include outlining global regulations, including FDA’s Process Validation Guidance; methodologies for streamlining the validation process; developing a process validation roadmap; developing acceptance criteria for process validation; utilizing quality virtual networks and cloud computing.

Sessions

  • FDA Regulatory Trends, Warning Letters and Enforcement Actions Related to Process Validation
  • Ripped from the Headlines — Process Validation Landmines & Pitfalls
  • Strategically Communicate with Both Internal and External Stakeholders to Ensure a Smooth Audit and Inspection Process
  • Cost Effective Lifecycle Validation Management
  • Reduce Risks and Costs of Laboratory Equipment Qualification — A Global Approach
  • Understand the Interdependency between Change Control and Validation
  • Sessions
  • Method Validation — Develop Processes that Survive the Lifecycle
  • Process Validation Lifecycle Management — Principles, Policies and Practice
  • Quality by Design — The Path to Lean Validation
  • Good Practices for Computerized Systems in GxP Environment — PIC/S Guidance
  • Planning and Executing a Process Validation Study
  • Writing Effective Validation Protocols, Execution and Results
  • Senior-level Think Tank — Strategies for the Advanced Validation Professional
  • Best Practices for a Robust Cleaning Validation Program
  • Conduct Prospective Validation
  • Lean Validation — Reduce Costs in the Computerized System Validation Process
  • Showing Your Quality System to the Inspector — How to Successfully Navigate a GMP Inspection
  • Qualification and Routine Environmental Monitoring of Critical Utility Systems Qualification
  • Critical Cleaning Processes — Eliminate Residue, Rouging and Corrosion
  • 21 CFR Part 11 — Computerized Analytical Instrument Validation
  • Conduct a Gap Analysis of Your Validation Program
  • Statistics in Validation — Sampling Plans that Result in Statistical Confidence
  • Conduct a Retrospective Validation
  • Risk and the Risk Mitigation Continuum — The GMP Perspective
  • Validation Master Plan (VMP) Development — A Risk-Based Approach
  • Understand and Handle Variation
  • Detect and Control Variation
  • Reduce Waste in Process Validation
  • Implement Risk Management in the Validation Process
  • HVAC and Purified Water System Validation — Case Study
  • Establish Testing Criteria for Validation
  • The Establishment of an Effective Requalification Program
  • Equipment Qualification — Fit for Intended Use
  • Documentation Requirements and Strategy for Each Stage of the Process Validation Lifecycle
  • Manage the Validation Quality System
  • Align FDA’s Process Validation with ICH Q8, Q9, and Q10
  • Continued Process Verification – Periodic Review of Process Design, Development and Maintenance
  • Audit Vendors on Validation Practice
  • PQ Forum – Validation Documentation Challenges
  • Sampling and Testing of In-Process Materials and Drug Product – A Risk Based Approach

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