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Setting up ATMP Quality Management Systems

Strategies for Compliance and Success

During this webinar you will learn how to effectively prepare for a compliant ATMP Quality Management System. Discover the key elements required to establish and maintain a QMS that adheres to Eudralex Part IV regulations.

Pharma & Biotech

随时观看

60 分钟

Quality Assurance · Pharma & Biotech

Chinese

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Watch the webinar on demand

What you'll learn

Essential components of a compliant Quality Management System (QMS) for ATMPs
Key steps to align your QMS with Eudralex Part IV regulations
Critical considerations for setting up and managing a QMS for ATMPs
Strategies to optimize ATMP quality processes for regulatory compliance

向最优秀的人学习

演讲者

Join us as our expert speaker shares valuable insights and practical knowledge drawn from extensive industry experience.

Lieve De Wolf

Quality Management Expert

Lieve De Wolf is a highly accomplished and passionate ATMP (Advanced Therapy Medicinal Products) supply chain expert, armed with a degree in industrial pharmacy from 2014. With extensive experience as the ATMP core team leader within the QbD Group, Lieve is at the forefront of driving innovation and excellence in the field. Presently, Lieve holds a pivotal role in the EMEA region, where she oversees surveillance audits and the qualification of sites for the commercial launch of CAR-T therapies. Through her expertise, Lieve is making remarkable strides in ensuring the highest standards of quality and compliance are met, ultimately contributing to the successful implementation of ATMP supply chains.

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