GMP University
Zifo is exhibiting and speaking at GMP University taking place on October 22-24 in RTP | Stop by our booth
Featured Talks:
Date/Time: October 23 | 2:50pm
Title: Building a Quality Culture for Use of AI/ML in GMP Environment
Speaker: Loganathan Kumarasamy, Head – Informatics & Compliance Services @ Zifo
Abstract:
-ML Use Cases in GMP Environment
-Defining AI/ML vision with the organization
-Understanding the various personas of AI/ML usage
-Building a Quality Management System for effective and secure use of AI/ML
-Setting up of Required Policies / Procedures and WIs when utilizing AI/ML in GMP Environment
-Training and Continuous Improvements
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Date/Time: October 23 | 2:00pm
Title: Effective Use of Change Control Methodologies for Lean Documentation
Speaker: Vivekram Apparsundaram, Head of Commissioning, Qualification and Validation @ Zifo
Abstract:
-Role of change control in maintaining the integrity, quality, and compliance of validated systems and instruments.
-Principles of Lean Documentation
-Strategies for integrating change control processes with lean documentation principles.
-Risk-Based Change Management and associated documentation
-Levers of cohort validation (family approach) in instruments space
Takeaway Tools:
-Model cohort validation (family approach) workflow
-Documentation Requirements and Best Practices