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Out-of-Specifications (OOS) Investigations
Date
September 23, 2020
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
President & CEO, Lachman Consultant Services
Speakers
EVP, Global Head Quality & Compliance, SUN Pharmaceutical Industries, Inc.
Carmelo Rosa, PsyD
Director, Division of Drug Quality I, FDA/CDER/OC/OMQ
Consumer Safety Officer, FDA/ORA
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