Out-of-Specifications (OOS)/Out-of-Trend (OOT) Investigations for Analytical Testing
August 23 - 24, 2018 - Montréal ON CAInternational Pharmaceutical Academy (IPA)
enquiry@ipacanada.com
Phone:4164107402
One and a half days interactive presentation, case studies, exercises and workshop. Deficiencies of Out-of-Spec (OOS) investigations continue to be the major cause of warning letters in the pharmaceutical industry. FDA requires that all out-of-specification results must be investigated; therefore, an effective and compliant quality management system requires well-documented, thorough investigations for OOS. Key challenges for many companies are having a clear understanding of regulatory expectations on how to handle OOS investigations. Lack of consistency around investigations and root-cause analysis processes will lead to error and expensive laboratory activities. This session will discuss the Guidance for Industry on OOS investigation issued in October 2006 by the FDA. As testing becomes critical to determine the cause of OOS results, investigation process will be discussed and procedure that will minimize OOS. It will also discuss the documentation system as well as CAPA activities. Day 1 – August 23, 2018 | Time: 9AM-5PM - Determine failing analytical results - Investigation Process for OOS/OOT - Discussing case studies for OOS investigation Day 2 – August 24, 2018 | Time: 9AM-1PM Workshop on: - Develop an investigation plan for different types of data - Establish trends and Corrective Actions and Preventive Actions (CAPA) - Interactive discussions on trending and OOT investigation