ComplianceOnline

How to Avoid an FDA Warning Letter with a Strong CAPA Program

Instructor: John E Lincoln
Product ID: 701085
  • Duration: 60 Min

recorded version

$229.00
1x Person - Unlimited viewing for 6 Months
(For multiple locations contact Customer Care)
Recorded Link and Ref. material will be available in My CO Section
Last Recorded Date: Mar-2015

Training CD

$399.00
One CD is for usage in one location only.
(For multiple locations contact Customer Care)
CD and Ref. material will be shipped within 15 business days

Customer Care

Fax: +1-650-565-8542

Email: customercare@complianceonline.com

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This CAPA program provides the framework for avoiding an FDA warning letter and increasing quality standards for your organization while keeping production levels high.

Description

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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Refund Policy

Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance. ComplianceOnline would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange.

Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time.

If you have any concern about the content of the webinar and not satisfied please contact us at below email or by call mentioning your feedback for resolution of the matter.

We respect feedback/opinions of our customers which enables us to improve our products and services. To contact us please email customercare@complianceonline.com call +1-888-717-2436 (Toll Free).

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