Sustainable Compliance for Out of Specifications

The CAPA system is an important QMS in the Pharmaceutical Industry, and is a critical tool to achieve sustainable compliance through continuous improvement. A robust CAPA system, supported by a thorough investigation to find a root cause helps in improving manufacturing operations, the company and the business. As per ICH Q10 Guidelines, the pharmaceutical company should have a system for implementing CAPA resulting from the investigation of complaints, product rejections, non-conformances, recalls, deviations, audits, regulatory inspections and findings, and trends from process performance and product quality monitoring. This seminar will discuss the data of exceptions during manufacturing operations and performing investigations into these observations using a structured approach with the objective of determining the root cause. The level of effort, formality, and documentation of the investigation should be commensurate with the level of risk, in line with ICH Q9 guidelines. Ways to implement corrections, corrective actions and preventive actions and a follow-up to monitor effectiveness and sustainability of these procedures will be described.

Throughout the course, specific examples with regard to achieving regulatory compliance during inspections and audits will be discussed. More importantly, the seminar will focus on understanding data of exceptions, including OOS, their impact on quality, finding a root cause in order to develop robust and effective CAPA procedures to achieve sustainable compliance.

Learning Objectives:

Upon completing this course the participants will understand:

• Role and Responsibilities of Quality Control Unit with regard to assuring manufacture of quality products consistently and to achieve sustainable compliance during laboratory operations
• Laboratory Quality Management Systems and their role in QC operations
• Data of Exceptions – Deviations, Non-Conformances, Out of Specifications (OOS), Out of Trend (OOT), Out of Frequency (OOF)
• Managing Data of Exceptions
• Biological Deviations
• Regulations, History, Background and Importance of OOS
• Uncertainty of Methods & Re-testing
• Re-test and Investigative Testing during OOS investigation
• Issues with Testing into Compliance
• Reportable Results and Averaging of Data
• OOS investigations for Microbiological data

Who Will Benefit:

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