Description: By applying the principles of ICH Q9 to equipment qualification, pharmaceutical, and biopharmaceutical manufacturers can optimize their qualification processes, allocate resources more effectively and enhance product quality while maintaining compliance with regulatory requirements. It provides a systematic approach to identifying, assessing, and managing risks associated with pharmaceutical processes, including equipment qualification. It’s important to note that Risk-Based Equipment Qualification is just one component of a broader quality risk management approach advocated by ICH Q9.
Risk-Based Equipment Qualification based on ICH Q9
August 30, 2023
12:00 - 13:00 CET
Organisation:
BiOZEEN
Mr. Devak Padmanabhan M.K.
Head of Quality Assurance & Management Representative for Quality Systems, BiOZEEN
Devak Padmanabhan, a passionate Biotechnologist, stands as a dynamic force in Quality Assurance. With a robust academic foundation, he wields expertise in intricate regulations like 21 CFR Part 11, ICH, WHO and ISO in shaping compliant practices. Having overseen the qualification of over 300 global equipment pieces, his meticulous approach and grasp of standards from ASME to CE underscore his capacity to unify excellence worldwide.
Beyond technical prowess, Devak’s diverse experience in Regulatory Affairs, Audits, and Quality Assurance showcases his risk-based thinking & holistic problem-solving skills. His proactive engagement with paperless validation and leadership in the Pharma 4.0 movement portrays his visionary adoption of emerging paradigms. Devak Padmanabhan's career symbolizes an amalgamation of regulatory grasp and innovative zeal, steering biotechnology into a future defined by precision, compliance, and cutting-edge advancement.
