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Establishing a Comprehensive and Robust Quality Management Systems to meet cGMP Regulation Requirements by Integrated Implementation of ICH Q8, Q9, Q10
会议时间：
2019年04月27日-2019年04月27日
主办单位：
Chinese Antibody Society
主题介绍：
The goal of this webinar is to promote the understanding of Quality in a GMP environment through the introduction and discussion of 1) quality key concepts; 2) the FDA Quality System Model and inspection trend; 3) integrated implementation of ICH Q8, Q9, Q10 for improved product quality and regulatory compliance.
Think about the following questions:
Who is responsible for the quality of the product, is it the scientists who developed the product and process, the Corporate Quality head, the QA personnel who conducted batch record review and released the lot, or the operators and their supervisors on the floor?
Is Quality’s role firefighting or fire prevention?
What Quality activities are needed for R&D?
What is Quality by Design (QbD), where and when can it be applied?
Do you know your risks? How can risks be identified, communicated, and mitigated?
How to build a quality culture?
Is your company inspection ready?
Hopefully by the end of the webinar you will be able to reach the answers or at least know where to find them.
Think about the following questions:
Who is responsible for the quality of the product, is it the scientists who developed the product and process, the Corporate Quality head, the QA personnel who conducted batch record review and released the lot, or the operators and their supervisors on the floor?
Is Quality’s role firefighting or fire prevention?
What Quality activities are needed for R&D?
What is Quality by Design (QbD), where and when can it be applied?
Do you know your risks? How can risks be identified, communicated, and mitigated?
How to build a quality culture?
Is your company inspection ready?
Hopefully by the end of the webinar you will be able to reach the answers or at least know where to find them.
会议日程：
Time: April 27th, Saturday, 9-10 pm, EST (April 28th, Sunday, 9-10 am, Beijing Time)
Speaker: Dr. Susan Qu
In Thermo Fisher Scientific (TFS), Dr. Qu is responsible for the Quality as applied to Analytical Methods Development, Validations, Documentation Management, Quality Control, Change Control, Auditing, Supplier Quality, and other Quality Management processes that insures a consistent supply of fit for purpose analytical products to a variety of customers from research to pharmaceutical production.
Susan has over 15 years of progressive leadership experience in drug development, quality operations and risk management in the pharmaceutical industry. Prior to joining TFS, she worked at Takeda as the Associate Director of Quality Risk Management and R&D Quality Systems. Prior to that, Susan worked in the pharmaceutical industry with Sanofi and Altus Pharmaceuticals. Susan specializes in the Quality Management System and corporate standard creation and lifecycle management. She led the global quality Community of Practice teams to identify and resolve cross-site quality issues, streamline, harmonize, and standardize quality processes, and to improve site compliance practice and inspection readiness. In addition, Susan is an expert in analytical method development, validation, and tech transfer for biopharmaceutical products.
Susan holds a Master of Business Administration in Entrepreneurship from Babson College and PhD in Biomolecular Analytical Chemistry from Emory University.
Speaker: Dr. Susan Qu
In Thermo Fisher Scientific (TFS), Dr. Qu is responsible for the Quality as applied to Analytical Methods Development, Validations, Documentation Management, Quality Control, Change Control, Auditing, Supplier Quality, and other Quality Management processes that insures a consistent supply of fit for purpose analytical products to a variety of customers from research to pharmaceutical production.
Susan has over 15 years of progressive leadership experience in drug development, quality operations and risk management in the pharmaceutical industry. Prior to joining TFS, she worked at Takeda as the Associate Director of Quality Risk Management and R&D Quality Systems. Prior to that, Susan worked in the pharmaceutical industry with Sanofi and Altus Pharmaceuticals. Susan specializes in the Quality Management System and corporate standard creation and lifecycle management. She led the global quality Community of Practice teams to identify and resolve cross-site quality issues, streamline, harmonize, and standardize quality processes, and to improve site compliance practice and inspection readiness. In addition, Susan is an expert in analytical method development, validation, and tech transfer for biopharmaceutical products.
Susan holds a Master of Business Administration in Entrepreneurship from Babson College and PhD in Biomolecular Analytical Chemistry from Emory University.
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