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2020 ISPE APAC Pharma Manufacturing Virtual Conference


Out-of-Specifications (OOS) Investigations


Sep 23, 2020 6:15am ‐ Sep 23, 2020 7:30am

Description

Out-of-Specifications (OOS) Investigations | Why are regulatory inspectors still finding problems in Out-of-Specifications (OOS) investigations? Discussion of real examples will help you and your company to understand the difference between root cause analysis and CAPA. Learn how to establish a reliable and sustainable quality system.

Session Leader(s):

Speaker(s):

  • Jila Breeze, EVP, Global Head Quality & Compliance, SUN Pharmaceutical Industries, Inc.
  • Carmelo Rosa, PsyD, Director, Division of Drug Quality I, FDA/CDER/OC/OMQ
  • Jose E. Melendez, Consumer Safety Officer, FDA/ORA

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