This text, based on workshops led by instructor and author James Vesper, provides practical tools for both a thorough understanding of risk-based CAPA investigations and regulatory acceptable applications.
Beginning with topics such as why and how much investigations matter, regulatory requirements, roles and responsibilities, the text then progresses to the big picture. It discusses the initial discovery, applying risk-based thinking to quality events and deviations, and moves on to specifics discussing:Models used in describing incidents
Human Errors and Human Factors
Methods and Tools
Immediate actions and corrections
Corrective actions and preventive actions
The author then explains training as a corrective action, evaluation of techniques, writing the report, review and approval, and communication and management responsibilities. It is the perfect companion for your library shelf or computer or, perhaps, both.
"Understanding how to properly plan and perform investigations, how to decide on effective means to address the outcome of such investigations, and how to use the knowledge gained from the experience are key to process reliability and improvement. That makes this book so important and the approaches presented in it so valuable. Enjoy the book. Learn from the journey".
Table of Contents:
Click here to download >>>Detailed Table of Contents
- Why Investigations and Corrective Actions Matter
- Regulatory Requirements and Expectations
- Roles and Responsibilities
- The Big Picture: Investigations and Corrective Actions
- The Initial Discovery of an Event
- Applying Risk-Based Thinking to Quality Events and Deviations
- Models Used in Describing Incidents
- Human Errors and Human Factors
- Methods and Tools Used When Conducting Investigations
- Immediate Actions and Corrections
- Corrective Actions and Preventive Actions
- Procedures: Causes of Problems and Potential Corrective Actions
- Training as a Corrective Action
- Corrective Action Evaluation and Effectiveness Checks
- Writing the Report
- Review and Approval of the Investigation and Report
- Learning From Successes and Failures
- Management Responsibilities
About the Author
James Vesper has worked in the pharma/biopharma industry for more than 35 years starting out at Eli Lilly and Company where his last position there was leading the GMP training initiative. For 24 years, he was President of Learning Plus, a training consultancy and, in 2017, he joined ValSource as Director of Learning Services. Dr. Vesper has written numerous books, book chapters and articles and also speaks and teaches at international conferences and workshops as well as consults for the World Health Organization. He received his Ph.D. in education from Murdoch University, Perth, Western Australia.