Qualification and Validation principles to meet revised schedule M requirements

About the Webinar
The Webinar will provide the objective and scope to detail the basic principles of qualification and validation, that can be applied to equipment, utilities, facilities and software within the life sciences industry. The qualification and validation principles are based on a lifecycle approach with the application of risk management principles.
The webinar will discuss the following topics broadly.
The current Regulatory expectations on delivering a typical project.
Basic principles of Lifecycle Management and the distinct phases.
Development of governance documents and Quality Management Systems
Implementation of a Science-based and Risk-based approach to the project\
Stay focused on Product Quality and Patient Safety
Requirements for Commissioning, Qualification & Validation activities.
Requirements for acceptance & release and continuous improvement
About the Speaker
Sundar Chellamani is Founder and Director, Plimco Limited Ireland. Sundar has a master’s in engineering and a certificate in Pharmaceutical Auditing. He is a highly capable hands-on Technical Engineer and Project Manager with more than 30 years of international experience in various senior roles specialising in Lifecycle Management and C&Q in countries such as Singapore, China, Poland, India and Russia with global companies such as Merck, Viatris and Pfizer.