Ma Yiling   　

Manager of the Validation Test Service department of Austar Group

Mr. Ma Yiling (Peter Ma) has been engaged in the pharmaceutical industry for 15 years with an experience in validation activities for more than 10 years. He is the manager of the Validation Test Service department of Austar Group and is responsible for the validation team of Austar. He has worked as the project manager for international certification and validation projects for numerous large domestic pharmaceutical enterprises and joint ventures and such validation projects involve validation services for all such products as vaccines, biological products, sterile products, solid dosage forms and APIs. He has rich experience in project management and validation and is familiar with the operation of various kinds of validation instruments. He is very familiar with all kinds of validation activities in pharmaceutical enterprises and has the capability and knowledge in organizing his team in performing such validation activities as risk analysis, Validation Master Plan preparation, validation management, clean HVAC system validation, water system validation, equipment sterilization validation and automation system validation. He is a member of the Promotion Sub-committee of International Society for Pharmaceutical Engineering (ISPE).

Abstract of speech

Title: Application of EU and US Risk Assessment Methods in Biological Product Plants .

This paper mainly introduces the relevant regulations on risk analysis and how validation scope and extent are determined through System Impact Assessment (SIA) and Component Criticality Assessment (CCA). During the validation of a biological product plant, SIA is used first to determine which systems/equipment is critical, then CCA is used to identify the critical components, and at the end the critical components are analyzed to determine what kinds of risks exist and what kinds of measures shall be taken to reduce such risks.