This Process Validation in Pharmaceuticals course provides a step-by-step understanding of validation principles, regulatory requirements, and industry best practices. You will learn about FDA, ICH, WHO, and EU GMP guidelines, different types of validation, and the validation lifecycle (Process Design, Qualification, and Continued Process Verification). The course covers equipment qualification, risk assessment, statistical tools, and troubleshooting techniques to ensure product consistency and regulatory compliance.

Key Topics:

✅ Introduction to Process Validation – Definition, importance, and regulatory requirements

✅ Regulatory Guidelines & Compliance – FDA, ICH, WHO, EU GMP standards

✅ Types of Process Validation – Prospective, Concurrent, Retrospective, Revalidation

✅ Validation Lifecycle – Process Design, Process Qualification, Continued Process Verification (CPV)

✅ Equipment & Facility Qualification – IQ, OQ, PQ explained

✅ Critical Process Parameters (CPPs) & Critical Quality Attributes (CQAs) – Identifying key factors

✅ Validation Protocols & Documentation – Master Plans, Reports, and Protocol Development

✅ Data Analysis & Statistical Methods – Control charts, process capability analysis

✅ Risk Assessment in Validation – Identifying, assessing, and mitigating risks

✅ Common Validation Challenges & Troubleshooting – Practical solutions and case studies