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Faculty: Danielle DeLucy


  • Date: 6/3/2021 01:00 PM - 6/3/2021 02:15 PM
  • Location: Online Event

Description

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