Within the Pharmaceutical Industry Corrective Actions and Preventive Actions are key elements to any Quality Management System that is focused on Continual Improvement and Customer Satisfaction.
A Corrective Action is based on a non conformance event that has happened in the past. Preventive Action is based on preventing a non conformance event in the future.
This programme provides an understanding of the basic concepts involved in Root Cause Analysis and the tools used to conduct detailed investigation and reporting.
The primary objective of this course is to develop an understanding of the principles and techniques involved in the practice of Root Cause Analysis. Emphasis is placed on the practical aspects of how to perform an analysis. In addition, this course will provide effective methods which can be used with a Corrective Action system to helps you and your team to ensure costly issues are resolved quickly and do not get dropped through the cracks.
Attendees will also learn advanced skills in root cause analysis, problem prevention, and continuous improvement. Included will be the identification of the characteristics and changes that have contributed to simple and complex problems and how to fix them, as well as, working with the tools and templates to capture all needed data to comply with CAPA reports.
Topics to be covered include:
- Efficient root cause analysis programs
- Developing effective training programs to ensure compliance
- Responding effectively to non-conformance s, failures, deviations and complaints by identifying root causes and implementing corrective and preventative actions
- Developing and implementing programs to prevent re occurrence
- Essential SOPs and Other Documentation
- Increasing accuracy through efficient documentation practices
- Areas of Regulatory Agency concerns
- Identifying and tracking deviations and non-conformances
- Responding to complaints and deviations with corrective and preventative actions
- Learning to analyze and trend data to identify existing and potential causes of non-conformance
- Integrating RCA with other systems: internal auditing, CAPA and complaint handling
- Gathering, organizing and managing the data required to conduct RCA
- Determining whether or not a complaint should go through a CAPA program
- Determining internal and external reporting requirements
- Writing effective SOPs
- Performing trend analysis and using effective RCA tools (Flow Charting, Fault Tree Analysis, Fishbone Diagrams, etc.)
- Analyzing FDA Warning Letters and common citations to avoid non-compliance
This course is intended for all personnel concerned with quality and the analysis & correction of problems. The material presented will be of value to varying levels of expertise among the participants, and will be pragmatic in emphasis. It will be particularly valuable to those newer to this field or those who wish to refresh their knowledge of these technologies.
About the Trainer
Finbarr Sheehy has over 25 years experience in the areas of Root Cause Analysis and Problem Solving. Finbarr has over 12 years CAPA experience within the Pharma industry. He has assisted in the design and redesign of Deviation Systems and Investigation Reviews.