Hetero is one of India’s leading pharmaceutical companies with a strong global footprint in over 126 countries. Founded with a vision to make healthcare affordable and accessible, Hetero has grown into a vertically integrated organization spanning Active Pharmaceutical Ingredients (APIs), Finished Dosage Formulations (FDFs), biosimilars, and branded generics. The company is recognized for its excellence in R&D, manufacturing, and regulatory compliance, supported by more than 36 state-of-the-art manufacturing facilities approved by stringent regulatory bodies such as the USFDA, EU EMA, TGA, and WHO-GMP.
This workshop was designed to provide an in-depth understanding of Computerized Systems Validation (CSV) aligned with GAMP 5 principles, tailored to the regulatory and operational realities of the pharmaceutical environment. The session aimed to enhance compliance readiness, reduce validation risks, and improve cross-functional collaboration between QA, QC, IT, and engineering teams.
The session focused on equipping participants with practical tools and a clear understanding of GAMP-based validation approaches. Through expert-led modules and real-world case studies, the workshop demystified CSV documentation practices and demonstrated how to embed compliance into system lifecycles—whether for lab equipment, enterprise platforms like SAP, or local manufacturing systems.
Key highlights included:
