Session Details

Quality and Operations Track Session 2 – Applied Risk Assessment
Thursday, May 30, 2019 03:45 PM - 05:00 PM
Room 213
Risk assessment is a valuable tool that can be used throughout all stages of the product life cycle. This session shall demonstrate via practical examples, the value applied risk assessment can bring to product development, apheresis site selection and qualification and scenarios that can occur during typical cell therapy manufacturing processes.

Gerry McKiernan, Cell Therapies Pty Ltd, Australia

A Risk Based Approach to Product Development
Jean Stanton, Janssen Pharmaceuticals, United States

Learning objectives:
• To introduce the concept of risk based approach and its use in product development
• Provide practical application of risk assessment tools through a case study
• Demonstrate how a risk based approach can be used to develop a systematically defined control strategy.

How Risk Management Is Applied to The Cellular Starting Material Used in The Manufacturing of A CAR-T Product
Jeanette Ripper, Novartis Australia, Australia

Learning objectives:
• Understanding that there are many risks associated with the cellular starting material used to manufacture a CAR-T product
• Understanding that there can be considerable challenges in standardising a critical starting material from a large and diverse network of global sites to align with manufacturing process needs
• Understanding that a well-developed risk-based approach is required to ensure that all patient cells received for CAR-T manufacturing meet established acceptance criteria

Reactive Risk Assessment Applied to Issues During Manufacturing
Susan Cheong, Cell Therapies Pty Ltd, Australia
In this session we will step through working examples looking at how we can use various Risk Assessment tools to determine the impact to products and the appropriate next course of action to mitigate reoccurring risks. A variety of Risk Assessment tools shall be demonstrated to show how different techniques can be used depending on the type of event encountered.