Faculty: Danielle DeLucy


  • Date: 11/1/2022 11:00 AM - 11/1/2022 12:15 PM
  • Location: Online Event

Tickets


Ticket Type
Qty
Live- Single
$250.00
0
For ONE Participant – Live session only
Live Corporate
$790.00
0
For Maximum of 10 participants – Live session only
Recording - Single
$390.00
0
Recording access for ONE participant (viewer) – Unlimited viewing access for 6 months
Recording - Corporate
$1400.00
0
Recording access (Multiple licenses) for up to 10 participants – Unlimited viewing access for 6 months

Total

$0.00

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