Process Validation LifeCycle

This training is intended to help you better understand and get familiar with best practices for Process Validation applicable for the highly regulated biological / pharmaceutical industry. This course is further intended to discuss the life cycle of the Process Validation system. You will learn when a process should be validated, the basic components of a Process Validation (IQ, OQ, and PQ) and how to write protocols and reports.

Learning Objectives:

•  Define the stages of the Process Validation Life Cycle
• Discuss what data should be included in the protocols/reports
• Analyze recent regulatory citations on pertaining to Process Validation

Areas Covered in the Session :

What is Process Validation?

• Regulatory Requirements
• Key Definitions
• The Stages of Process Validation

Process Validation Implementation

• Installation Qualification
  – Drafting the Protocol, Data Gathering, Writing the Report
• Operational Qualification

  – Drafting the Protocol, Data Gathering, Writing the Report

• Performance Qualification
  – Drafting the Protocol, Data Gathering, Writing the Report

Case Studies

• FDA 483 Citation Review
• Warning Letter Review

Who Should Attend:

• Research and Development Departments
• Quality Assurance Departments
• Quality Control Departments
• Manufacturing Departments
• Engineering Departments
• Operations Departments
• Production Departments
• Documentation Departments
• Validation Teams