FDA's Quality Management Maturity Program: Why Should CDMOs Adhere to the New CDER's Rating System?

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Webinar Date/Time: Wed, Sep 27, 2023 11:00 AM EDT

Uncover the pathway to excellence in pharmaceutical manufacturing! Join the webcast with Rebecca Alcantara, Director of Global Supplier Quality & Compliance at Curia, as she reveals game-changing strategies through the FDA's Quality Management Maturity program and the CDER's rating system.

Register Free: https://www.biopharminternational.com/bp_w/quality-management-maturity

Event Overview:

The objective of this webinar is to explore the Food and Drug Administration’s (FDA’s) Quality Management Maturity (QMM) program and its benefits, including the rating system currently being developed by the FDA’s Center for Drug Evaluation and Research (CDER) to incentivize drug manufacturers to achieve QMM. This webinar will also review possible challenges that CDMOs may face in achieving high scores, as well as the steps to overcome these challenges to ensure the delivery of high-quality products.
As a contract development and manufacturing organization (CDMO), Curia’s primary goal is to produce high-quality pharmaceuticals that meet the needs of clients and ensure the safety and well-being of the final consumers, patients. To achieve this, it is essential to have an in-depth understanding of the Food and Drug Administration’s (FDA’s) Quality Management Maturity (QMM) program.


Key Learning Objectives:

  • Understand the FDA's QMM program and CDER's rating system.• Identify the advantages and benefits of adhering to the QMM program and rating system for CDMOs.
  • Learn how to overcome challenges and learn the steps for success in achieving high scores in the CDER's rating system.


Who Should Attend:

  • Quality professionals
  • CDMO and manufacturer site leadership
  • Regulatory affairs

Speaker:

Rebecca Alcantara
Director, Global Supplier Quality & Compliance
Curia

Rebecca Alcantara is the Director of Global Supplier Quality & Compliance at Curia Global, Inc. She has been a quality professional for over 10 years, working in both pharmaceuticals and healthcare. In her current role at Curia, she is responsible for introducing and informing audiences about the FDA’s new QMM program. Rebecca has been following the program since it was announced and has met with the FDA to provide feedback as Curia’s representative in the Bulk Pharmaceuticals Task Force (BPTF).

Register Free: https://www.biopharminternational.com/bp_w/quality-management-maturity

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