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  4. FDA/PQRI Workshop: ANDA Quality with CDER’s Office of Pharmaceutical Quality - 03/20/2025
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Workshop | In Person

Event Title
FDA/PQRI Workshop: ANDA Quality with CDER’s Office of Pharmaceutical Quality
March 20 - 21, 2025

Scheduled
Date:
March 20 - 21, 2025
Day1:
Thu, Mar 20 8:30 a.m. - 05:00 p.m. ET
Day2:
Fri, Mar 21 8:30 a.m. - 05:00 p.m. ET
Website:
https://pqri.org/fda-pqri-anda-quality-workshop/

This FDA/PQRI Workshop will bring together experts from industry and senior leaders from CDER’s Office of Pharmaceutical Quality (OPQ) for interactive discussions on critical topics related to generic drug manufacturing and quality.

This workshop aims to facilitate interaction among stakeholders to:

  • Discuss real-world issues related to generic drug manufacturing, including drug substance and DMF, drug product, and facilities
  • Understand common problems with inspections and remote regulatory assessments
  • Discuss analytical testing, including compendial, in-house, and third-party testing

Additionally, this workshop will present opportunities to directly engage with OPQ senior-level experts and leaders through panel discussions and additional interactive components.

For more information, please visit the Product Quality Research Institute (PQRI) webpage.

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