Pharma Analytical Method Validation (ICH Q2)
Kirit Ladage
About Me
A pharmaceutical R&D professional with over 30 years of experience in small-molecule development, specializing in analytical development, quality control, and GMP-compliant operations. Proven expertise in operational governance, project management, risk assessment, and process improvement, with a strong track record of delivering efficiency-driven initiatives. Extensive experience leading QC laboratories, including method setup, equipment calibration, preventive maintenance, and audit management. Successfully implemented a stage-gate process for new product development, reducing development timelines and improving productivity. Well-versed in global regulatory compliance across USFDA, TGA, WHO, MHRA, ANVISA, PMDA, and other major authorities.Courses by me
Plan and execute regulatory-compliant analytical method validation aligned with global expectations, reduce inspection observations linked to validation gaps, evaluate validation data to confirm method suitability and reliability, and maintain a validated state throughout the product life cycle.