Learn how to use and how far to go with an effective and efficient approach for your CAPA investigation. This webinar will provide valuable assistance and guidance to all regulated companies that are preparing to use or are currently using risk-based tools for CAPA investigations and closing out investigations in a timely manner.
CAPA programs are critical for any manufacturer. FDA considers your program the immune system for your site business unit and determines how healthy or unhealthy you are. Industry is now using various risk-based approaches and tools to set-up, deploy and maintain their CAPA programs to help with the decision making process. Understand the emphasis on analyzing processes, work operations, concessions, quality audit reports, quality records, service records, complaints, returned product, and other sources of quality data to identify existing and potential causes of nonconforming product, or other quality problems...and the use of appropriate statistical methodology where necessary to detect recurring quality problems. Learn some of the new practices being used on how to conduct the CAPA investigation and the use these tools.
Learn how to use and how far to go with an effective and efficient approach for your CAPA investigation.
How to facilitate a product complaint investigation as part of your CAPA program?
What is a closed-loop investigation…cradle to grave approach?
How to conduct an investigation using a well-written CAPA policy and procedure?
Understand and comprehend what FDA is looking for in meeting minimum expectations…no band-aid solutions.
Why risk assessment and risk-based approaches, FMEA, FTA, HACCP, etc., are now the expectation in terms of good business practice.
Establish a priority system as related to major versus minor or high risk versus low risk classifications…to support your decisions.
CAPA programs are critical for any manufacturer. FDA considers your program the immune system for your site business unit and determines how healthy or unhealthy you are. Industry is now using various risk-based approaches and tools to set-up, deploy and maintain their CAPA programs to help with the decision making process. Understand the emphasis on analyzing processes, work operations, concessions, quality audit reports, quality records, service records, complaints, returned product, and other sources of quality data to identify existing and potential causes of nonconforming product, or other quality problems...and the use of appropriate statistical methodology where necessary to detect recurring quality problems. Learn some of the new practices being used on how to conduct the CAPA investigation and the use these tools.
Areas Covered in the seminar:
How to use FMEA effectively and calculating Risk Priority Numbers: How to Use the Criteria?Learn how to use and how far to go with an effective and efficient approach for your CAPA investigation.
How to facilitate a product complaint investigation as part of your CAPA program?
What is a closed-loop investigation…cradle to grave approach?
How to conduct an investigation using a well-written CAPA policy and procedure?
Understand and comprehend what FDA is looking for in meeting minimum expectations…no band-aid solutions.
Why risk assessment and risk-based approaches, FMEA, FTA, HACCP, etc., are now the expectation in terms of good business practice.
Establish a priority system as related to major versus minor or high risk versus low risk classifications…to support your decisions.
Who Will Benefit:
This webinar will provide valuable assistance and guidance to all regulated companies that are preparing to use or are currently using risk-based tools for CAPA investigations and closing out investigations in a timely manner. The employees who will benefit include:- All levels of Management for all departments
- QA/QC/Compliance/Regulatory Affairs
- Marketing & Sales
- Engineering/Technical Services
- Consultants
- Operations and Manufacturing
Course Provider
David Dills,
