How to Avoid an FDA Warning Letter with a Strong CAPA 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

Instructor Profile:

John E. Lincoln is principal of J. E. Lincoln and Associates LLC, a consulting company with over 31 years’ experience in U.S. FDA-regulated industries, and 17 years as a full-time consultant. Mr. Lincoln has worked with companies from start-up to Fortune 100, in the U.S., Mexico, Canada, France, Germany, Sweden, China and Taiwan. He specializes in quality assurance, regulatory affairs, QMS problem remediation and FDA responses, new / changed product 510(k)s, process / product / equipment including QMS and software validations, ISO 14971 product risk management files / reports, design control / design history files, and technical files. He's held positions in manufacturing engineering, QA, QAE, regulatory affairs, to the level of director and VP (R&D). In addition, Mr. Lincoln has prior experience in military, government, electronics, and aerospace. He has published numerous articles in peer reviewed journals, conducted workshops and webinars worldwide on CAPA, 510(k)s, risk analysis / management, FDA / GMP audits, validation, root cause analysis, and others. Mr. Lincoln is a graduate of UCLA.

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