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%)