VOMP 3008 – Planning a Validation Strategy

Course Topics

LESSON 1: (8 Topics)

  • 1.1 Module Introduction and Overview
  • 1.2 What’s New in Quality and Validation – Introduction
  • 1.3 ICH Overview
  • 1.4 ICH Q8
  • 1.5 ICH Q9
  • 1.6 ICH Q10 Part 1
  • 1.7 ICH Q10 Part 2 and Q11
  • 1.8 ICH Regulatory and Industry Reaction

LESSON 2: (5 Topics)

  • 2.1 ASTM E2500 Part 1
  • 2.2 ASTM E2500 Part 2
  • 2.3 ISPE Part 1
  • 2.4 ISPE Part 2
  • 2.5 ISPE Part 3

LESSON 3: (2 Topics)

  • 3.1 FDA Process Validation Part 1
  • 3.2 FDA Process Validation Part 2

LESSON 4: (6 Topics)

  • 4.1 Module update and lesson 4 Overview 4.2 The Concept of Quality
  • 4.3 Evaluation of Regulation EU
  • 4.4 Evaluation of Regulation US
  • 4.5 Quality Management System
  • 4.6 The Quality Manual

LESSON 5: (5 Topics)

  • 5.1 Validation Master Plan Part 1
  • 5.2 Validation Master Plan Part 2
  • 5.3 Supplier and Vendors
  • 5.4 Supplier Qualification
  • 5.5 Process Validation -Introduction

LESSON 6: (3 Topics)

  • 6.1 Process Validation – CQA’s and CPP’s
  • 6.2 Process Validation Protocol
  • 6.3 Executing the Validation Study

LESSON 7: (4 Topics)

  • 7.1 Module Review and lesson 8 Overview
  • 7.2 Process Validation Report
  • 7.3 Cleaning Validation Overview
  • 7.4 Health and Safety at the Operator/Product Interface

LESSON 8

  • 8.1 Assignment Part 1, (30%)
  • 8.2 Assignment Part 2, (70%)