Handling OOS Test Results and Robust Investigations

🎤  G. Sundar ‎ ‎ ‎       |  📅  October 29, 2024   |  🕒  11 AM Eastern Time US

AREAS COVERED IN THE SESSION:    Introduction Determining Potential Product Impact through OOS investigation The Investigation – Trigger (OOS-How from day to day today analysis) Root Cause Analysis –Flow with Investigation Tools RCA Tools with Case studies Documentation of OOS with Phase-wise check list, (Failure Investigation Report) Handling of OOS-Investigations. A detailed SOP with OOS form Corrective and Preventive Action Tracking and Trending Recent OOS Regulatory agencies cited examples by USFDA/MHRA Key Elements of the Investigation Report (RCA Report) Questions and answer section

Description:

When regulatory authorities audit drug manufacturers, one of the most common issues they uncover is the inadequate investigation of failures, particularly those arising from Out of Specification (OOS) results. Authorities expect thorough investigations to uncover non-compliance, followed by effective interventions and a review of those interventions' success. Without a proper investigation and root cause analysis (RCA), organizations struggle to implement successful corrective actions, often wasting significant resources on ineffective solutions.

Many manufacturers face challenges complying with FDA, EU GMP, and WHO standards regarding Corrective and Preventive Actions (CAPA). Given that CAPA impacts nearly every facet of manufacturing operations, it's essential for all employees to understand the fundamentals—what CAPA is, why it matters, and how it works. However, simplifying the complexities of failure investigations and CAPA can be a daunting task, especially when non-compliance issues escalate to severe regulatory concerns.

Why You Should Attend:

Current Regulators expectations is that “A firm’s primary goals in investigating a Failure incident should include both discovering its cause and ensuring it does not reoccur”.

Regulators now expect that manufacturers prioritize discovering the cause of a failure and ensuring it doesn’t reoccur. This advanced training focuses on Out of Specification (OOS) failures, failure investigations, and root cause analysis (RCA), providing participants with the skills to conduct thorough investigations that reveal the true cause and develop CAPA strategies that prevent recurrence. This course also delves into current regulatory expectations regarding failure investigations, RCA, and implementing CAPA to improve Good Manufacturing Practices (GMP) and Quality Control (QC) systems.

Who Should Attend:

• Quality Assurance Departments
• Quality Control Departments
• Research and Development Departments
• Regulatory Affairs Departments
• Manufacturing Departments
• Engineering Departments
• Operations Departments
• All API and Formulation Companies