This CAPA program provides the framework for avoiding an FDA warning letter and increasing quality standards for your organization while keeping production levels high.
This course is appropriate for professionals who work within and manage a quality discipline for their organization.
A strong and manageable CAPA program is critical in an FDA regulated environment. Over 50 warning letters have been issued to manufacturers in the medical device industry because of inadequate quality system procedures. This CAPA program provides the framework for avoiding an FDA warning letter and increasing quality standards for your organization while keeping production levels high. How to Avoid an FDA Warning Letter with a Strong CAPA Program integrates FDA requirements and guidelines while offering tips and techniques for effective investigations, documentation, and data collection- all in the understandable language necessary for a successful CAPA (Corrective and Preventive Action) program.
This course is appropriate for professionals who work within and manage a quality discipline for their organization.
A strong and manageable CAPA program is critical in an FDA regulated environment. Over 50 warning letters have been issued to manufacturers in the medical device industry because of inadequate quality system procedures. This CAPA program provides the framework for avoiding an FDA warning letter and increasing quality standards for your organization while keeping production levels high. How to Avoid an FDA Warning Letter with a Strong CAPA Program integrates FDA requirements and guidelines while offering tips and techniques for effective investigations, documentation, and data collection- all in the understandable language necessary for a successful CAPA (Corrective and Preventive Action) program.
Areas Covered in the Webinar:
- Understand the FDA’s requirement for a strong quality system and key focus points for improvement.
- Examine common areas of the quality system where critical mistakes are made.
- Understand your role and the FDA’s requirements and expectations during a quality inspection.
- Learn how to identify timely and accurate Corrective and Preventive Actions(CAPA) within the quality system.
- Discuss tips and techniques for investigating and documenting non-conformances.
Who Will Benefit:
This course is appropriate for professionals who work within and manage a quality discipline for their organization.- Engineers
- Investigators
- QA/QC Professionals
- Manufacturing Supervisors
- Technicians
Course Provider
John E Lincoln,
