The Common Compliance Issues in a Quality Control Laboratory - Data Integrity, Out of Specifications (OOS), Corrective and Preventive Actions (CAPA) 2016 is a seminar that covers topics such as:
- 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
The Common Compliance Issues in a Quality Control Laboratory - Data Integrity, Out of Specifications (OOS), Corrective and Preventive Actions (CAPA) 2016 brings together:
- 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
