Pharmaceutical Process Validation and Equipment Qualification Training
About This eLearning
This self-paced digital learning course provides comprehensive instruction on pharmaceutical manufacturing process validation and equipment qualification. The program is presented in three modules for approximately 4.5 hours* of content.
Completing NSF’s pharmaceutical process validation training will give learners a holistic view of validation encompassing pre-validation studies, process development and process evaluation. The course emphasizes modern approaches that apply principles of QbD, PAT and ongoing quality risk management (QRM).
Module 1: Introductory Topics (approximately 1 hour)
At the end of this module, you will be able to:
- Explain the purpose of equipment qualification and process validation
- Describe how performance supports product quality by reducing variability
Module 2: Intermediate Topics (approximately 1.5 hours)
At the end of this module, you will:
- Understand why, what and how to perform validation
- Learn the stages of process validation
- Understand the importance of change control in the context of pharmaceutical quality systems
- Recognize the importance of building in system safeguards (engineered or procedural)
Module 3: Advanced Topics (approximately 2 hours)
At the end of this module, you will be able to:
- Discuss modern process validation and guidance (FDA and ICH)
- Understand the importance of pre-validation studies to develop process knowledge
- Outline the importance of quality risk management and how it applies to process validation (ICH Q09)
- Identify the importance of validation design and how to reduce variability
- Outline a framework for reducing potential product quality and patient risks during commercial manufacturing and throughout the product lifecycle
*This online course is self-paced. Completion times are estimated based on the amount of content in each module.