Proper change management practices play critical role in GMP facilities. The change management during GMP operations is part of Quality Management System and is generally well defined and understood. But the change management during initial stages of facility life cycle is often a gray area. Misconceptions and improper CM practices can subsequently lead to issues ranging from inefficient facilities and even product quality risk.
This webinar focuses on the change management right from the beginning phases. Understand the CM approaches through different stages: when the project is created, requirements are being defined, through conceptual-preliminary-detail design stages, during transition from project execution to C&Q, during C&Q, subsequently during plant operations.
What guidance is available in industry’s public domain documents?
What are some of the insights based on real-life experiences? Potential pitfalls and gaps if CM is not adequately defined and implemented during initial stages. Examples from biopharma facility.
Sanjay B. Shah, VP Global Engineering, Hyde Engineering + Consulting, India/USA
Sanjay has over three decades of diverse experience with prominent multi-national biopharmaceutical and engineering consulting organizations; he has spent 16+ years in the US and later in Asia. Sanjay worked for Eli Lilly, Amgen, and Kvaerner in the US; and for DRL, Syngene and Intas in India. Prior to rejoining Hyde, Sanjay worked as VP with Pfizer Global Engineering.
Sanjay is a recognized SME in process engineering and design, process automation for biopharmaceutical and sterile injectables facilities. He led projects and has firsthand experience right from inception through design, execution, start-up/CQV, upgrades, and improvements of biotech facilities. He has also led manufacturing operations, site engineering and validation functions at large pharma sites. His experience seamlessly bridges from creation through operations lifecycle.
Sanjay holds Master’s in Chemical Engineering from the US. And Bachelor’s in Chemical Engineering from India.