What Are Some Critical Elements to Ensure Full Transparency between Industry & Regulatory Agencies?

The global pharmaceutical industry continues to face unexpected challenges in responding to the world’s pandemic. The impact on normal operations has been felt in companies of all sizes, with varying manufacturing capabilities, no more intensely than in the Asia Pacific region.

The 2021 ISPE Asia Pacific Pharmaceutical Manufacturing Conference will address this impact and the most critical issues, with a special emphasis on practical application using a series of case studies implementing quality risk management (QRM) principals.

Register now to benefit from unparalleled real-time engagement with regulatory leaders and industry during interactive sessions and panel discussions as they share their perspectives on how to:

  • Implement QRM principles in addressing OOS investigations, cross contamination, data review, and aseptic processing controls
  • Navigate distance assessments, audits, and alternative avenues for reviews
  • Develop comprehensive responses to regulatory actions - And more

In this clip, hear from Carmelo Rosa, PsyD, Program Co-Chair, Director, Division of Drug Quality I, FDA/CDER/OC/OMQ, as he answers the question: What are some critical elements to ensure full transparency between industry and regulatory agencies?

Learn More & Register

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