Presented by: Sunil Patel, Director of Centre of Excellence, ValGenesis®

Cleaning validation is a complex process. Over the years, the industry has moved on with a structured risk based lifecycle approach following FDA Process Validation Lifecycle principal guidance. Using old processes, it remains a challenge to eliminate human errors. This presentation shows how to automate and digitize your cleaning validation program that will help users perform cleaning validation activities in consistent manner to ensure an efficient, safe, and compliant cleaning validation program.

Topics covered in this session:
– Pain Points of Paper-based Cleaning Validation
– Cleaning Validation Lifecycle Model following ICH9 Risk Management Principles
– Automated Product and Equipment Assessments
– Automated Worst Case Product and Equipment Identification
– Residual Limit Calculations with integrated Analytical Method Limits
– Critical Cleaning Matrices Development
– Manage Cleaning Validation Program
– Cleaning Validation Documentation

– How to digitize the end-to-end cleaning validation life cycle
– Project Management and Task Dependency
– Utilizing the power of data for the dashboard and quality metrics


Sunil Patel

Director, Center of Excellence, ValGenesis

Sunil has over 17 years of experience working in the engineering and validation fields of cGMP / FDA / EU / ISO regulated industry sectors. Sunil has a strong background in Cleaning Validation (CIP, COP, Manual), Process Validation, Process Design, Clean Utilities (WFI, PW, Clean Steam, Clean Air, Clean Gases), HVAC, Project Management, Sterilization and Processing Equipment Validation. Further expertise includes Process Optimization/Improvement, Regulatory Compliance and Risk Management methodologies for the pharmaceutical and biologics industry. Prior to joining ValGenesis, Sunil has had a variety of Validation roles as consultant and corporate employee with increased responsibilities within the Pharmaceutical and Biologics industry, including Catalent, Eisai, Pfizer, Teva and Novartis.

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