2021 - Sustainable Compliance for Out of Specifications (OOS) Results, Deviations, and Corrective and Preventive Actions (CAPA)

Day 01(10:00 AM to 5:00 PM EST)
Introduction – Roles & Responsibilities of Quality Control Unit and Overview of Laboratory Quality Management System
Quality Control Unit (21 CFR 211.22)
Reporting Structure
Responsibilities
Laboratory Quality Management Systems
An Overview
Data of Exception
Understanding Data of Exceptions
Deviations, Non-Conformances, Out of Specifications (OOS), Out of Trend (OOT), Out of Frequency (OOF)
How to Manage Data of Exceptions
Deviations & Non Conformances
Biological Product Deviations (BPD)
Out of Trend
Out of Tolerances
Out of Frequency
Out of Specifications (OOS)
Understanding OOS
Regulations, History and Background
FDA’s Citations on OOS in QC Labs
Uncertainty of Methods & Re-testing
Barr’s Case
Day 02(10:00 AM to 5:00 PM EST)
Out of Specifications (OOS), Continued
FDA Guidance Document on OOS
Phase I Investigation
Phase II Investigation
Re-testing
Re-Sampling
Outlier Test
Concluding the Investigation & Final Thoughts
Root Cause Analysis
OOS in Microbiological Testing
Challenges
Best Practices
Example – Investigation in Sterility Test Failure
Mitigating OOS Risk
Corrective and Preventive Actions (CAPA)
Definitions
Correction
Corrective Action
Preventive Action
Regulatory Requirements and Guidance
CAPA Process
Non Conformance/Deviation/OOS (Problem)
Root Cause Analysis
Identify Root cause (Critical for Effectiveness of CAPA)
Correction of Problem
Corrective Action
Implement CA
Preventive Action
Monitoring Effectiveness and Sustainability of CAPA
Review
Verify (Problem does not recur)
Analyze (Monitoring)
Making Change to Approved Applications (Change Control)