This CAPA webinar will teach development and implementation of a corrective action plan and suggest how to verify effectiveness of corrective action so as to prevent occurrences instead of re-occurrences.
Corrective and preventive actions (CAPA) can be considered the "looking glass" of a company, by exposing to the FDA, ISO, and upper management the overall health of the operation, be it good or bad. Bad in the sense that multiple problems that have not been fixed expose how poorly a company's production and quality systems are operating, and good if multiple CAPA's have been closed showing due diligence and a keen understanding of how to solve problems, with no re-occurrences. Often times a CAPA program is used a depository for problems, eventually overwhelming the system with issues, which are not properly mediated due to a lack of technical understanding of what it takes to determine a true root cause, and fix an issue to avoid re-occurrence.
Companies solving problems effectively will be able to then grow by focusing on preventing occurrences, rather than re-occurrences. This session will review the inputs to a CAPA program, pitfalls when trying to correct problems, and walking through an easy to understand real life problem-solving example following a concise corrective action outline that can be utilized and understood by any level of employee. The technique and theory discussed can be utilized in any environment in or out of the workplace.
Areas Covered in the seminar:
- Review of the inputs of a CAPA system.
- Why corrective actions are necessary.
- Simple root cause determination.
- Documenting a correct problem statement.
- Developing and implementing a corrective action plan.
- Verifying effectiveness of corrective actions.
- Common CAPA mistakes.
- Prevention of occurrences instead of re-occurrences.
Who will benefit:
This webinar will provide valuable information to employees of any industry who are tasked with solving problems and/or are required to give input into a CAPA program. The employees who will benefit include:
- CAPA program managers
- QA employees
- Employees in a problem-solving capacity
Instructor Profile:
Phil Guarino, is a Managing Partner of Quality Solutions Now (QSN) a consulting firm providing regulated industries with expertise in project management, process improvement, quality system implementation and compliance, product and process development, as well as auditing and training support. Phil has entered his 22nd year working within FDA and ISO regulated industries. He has developed and implemented quality systems, performed over 200 cGMP audits, and has managed numerous FDA and ISO audits. Phil has developed and executed training programs for the medical device, Pharma, and food manufacturing industries throughout the US, Europe, Caribbean, and Asia.
