This course will cover FDA approach on PPQ and CPV concept, rationale, writing protocols, reports and master validation plans, as well as the regulatory requirements of process validation that lead to risk-based, practical and scientific informed decisions and planned activities. It focuses on real work industrial scenarios. You will know how to initiate and conduct process validation studies in pharmaceutical and biopharmaceutical industries. You will also learn the related current process validation regulations and report writing for those validation studies.
PHARMACEUTICAL PROCESS PERFORMANCE QUALIFICATION