K Bangarurajan | Deputy Drugs Controller West Zone CDSCO | India
Conference Day 2 @ 14:10
Ensuring uniformity of GMP inspections in biologics manufacturing
Biologics ManufacturingCountries across the globe are concerned about the safety and efficacy of the drugs supplied. As India expands its biologics supply globally, there is an increased emphasis in ensuring uniformity in inspection requirements for drugs manufactured in India. This panel discusses how global regulators such as US FDA, EMA can work closer together with CDSCO in ensuring uniformity in GMP inspections.
Overview of India’s inspection landscape and updates
Understanding the differences and overlaps in current standards
Exploring ways for various regulators to work closer together, including more combined inspections for newly recruited CDSCO inspectors
Chandra Sekhar / Ensuring uniformity of GMP inspections in biologics manufacturing
Chandra Sekhar, Vice President of Quality Pharma, Reliance Life Sciences
Chandra Sekhar is currently Vice President-Quality-Pharma at Reliance Life Sciences based in Navi Mumbai. Prior to that, he was looking after the Data Integrity function at Ranbaxy. He is a Certified Quality Auditor from American Society for Quality (ASQ). He has Pharma QC, QA, Compliance...