Common Compliance Issues in a Quality Control Laboratory - Data Integrity, Out of Specifications (OOS), Corrective and Preventive Actions (CAPA) 2016

Key Topics

• Laboratory Quality Management Systems and their role in QC operations
• Role and Responsibilities of Quality Control Unit with regard to assuring manufacture of quality products consistently and to achieve sustainable compliance during laboratory operations
• Raw Data - Paper, Hybrid, Electronic
• Data Integrity issues and their Importance for public health
• Correcting and Preventing Data Integrity Issues
• Causes for Data Integrity Issues
• Managing Data of Exceptions
• Data of Exceptions - Deviations, Non-Conformances, Out of Specifications (OOS), Out of Trend (OOT), Out of Frequency (OOF)
• Regulations, History, Background and Importance of Out of Specifications (OOS)
• Biological Deviations
• Re-test and Investigative Testing
• Uncertainty of Methods & Re-testing
• Reportable Results and Averaging of Data
• Issues with Testing into Compliance
• Root Cause Analysis for Investigations from Deviations, Non-Conformances, Out of Specifications (OOS), Out of Trend (OOT), Out of Frequency (OOF)
• OOS Investigation - Phase I Investigation, Phase II Investigation, Re-testing, Re-Sampling, Outlier Tests
• Effectiveness and Sustainability of CAPA
• Correction, Corrective Actions and Preventive Actions

Who should Attend

• Biotech Industry
• Pharmaceutical Industry
• Analytical Development Managers and Scientists
• Managers and Scientists involved in Drug Development
• Quality Assurance Staff for Informed Review of Data and for Managing and Providing Oversights on data integrity, Investigations, CAPA, etc
• Quality Control Managers and Scientists
• Senior Management and Corporate Team