Sustainable Compliance for Out of Specifications (OOS) Results 2021
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.
Upon completing this course the participants will understand: