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Setting up ATMP Quality Management Systems: Strategies for Compliance and Success

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On demand
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1h
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ATMP
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English

This webinar will tell you more about how to prepare effectively a compliant ATMP Quality Management System. Discover the key elements required to establish and maintain a QMS that adheres to Eudralex Part IV regulations.

 

Gain valuable insights into the critical considerations involved in setting up and managing a QMS in alignment with Part IV guidelines. Don’t miss this opportunity to optimize your ATMP quality processes and ensure regulatory compliance.

 

Agenda

00:00 – Introduction
03:00 – QbD at a glance
06:32 – ATMP
11:00 – QMS
30:32 – QbD methodology
51:00 – Key conclusions

Webinar - Setting up ATMP Quality Management Systems Strategies for Compliance and Success - QbD Group

Speaker

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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