Pharmaceutical Process Validation and Equipment Qualification Training

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.