This self-paced learning course provides comprehensive instruction on the Process Validation and Equipment Qualification in pharmaceutical manufacturing. The program is presented in three modules: - approximate course completion time = *4.5 hours. Once you finish the first module, you will automatically begin the next module within this course. Completing the three modules will provide learners with a holistic view of validation encompassing pre-validation studies, process development, and process evaluation, emphasizing 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 differences between active pharmaceutical ingredients, a bulk drug substance, and drug product
- Explain the r 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 important 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
*The course is self-paced so completion times are approximate, based on the amount of content in each section.
By completing/passing this course, you will attain the certificate Pharma Certificate
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