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Modifications to a Cleared Device - FDA's 510(k) Guidance

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This 90-minute webinar will explain FDA's 1997 guidance on 510(K) for device modifications and show how to integrate the evaluation into your design change program. The webinar uses numerous Warning Letters to illustrate the points, and helps you learn from others.

Speaker
Instructor: Daniel O Leary
Product ID: 702595
Training Level: Intermediate to Advanced

Course "Modifications to a Cleared Device - FDA's 510(k) Guidance" has been pre-approved by RAPS as eligible for up to 1.5 RAC credits towards a participant's RAC recertification upon full completion.

In January 1977, the FDA issued a guidance document to help device manufacturers understand when changes require a new 510(k). In 2011, FDA issued a draft guidance, that included a number of new proposals, with the intention of replacing the 1997 version. But, a new law, signed by the President on July 9, 2012, instructs the FDA to take a new direction and leaves the 1997 guidance in place.

Now is the time to review the 1997 guidance and make sure that your quality management system implements it. This webinar will help you identify the kinds of changes to consider, understand the regulation, and apply the guidance document.

The most important aspect of the webinar, however, is the approach to integrate the change control program across all the regulatory requirements. For example, do your complaint investigations lead to corrective actions, updates to your risk management file, product changes, and evaluation for 510(k) change? In the webinar, you learn how to make these links. You will also learn how to evaluate changes using the methods in the guidance, make the decision, and create adequate records.

At the end of the webinar, you will be able to implement a robust system that incorporates all the elements of product change control.

Why Should You Attend:

Your Quality Management System (QMS) should be able to address these questions quickly and easily. If not, then your team needs to attend this webinar!

Areas Covered in the Webinar:

Who will Benefit:

This webinar is for people involved in product change from recognition of a potential change to implementing the change to notifying FDA when required.

People in the following roles can especially benefit from the knowledge in this webinar:

Instructor Profile:

Dan, is the President of Ombu Enterprises, LLC, a company offering training and execution in Operational Excellence, focused on analytic skills and a systems approach to operations management. Dan has more than 30 years experience in quality, operations, and program management in regulated industries including aviation, defense, medical devices, and clinical labs. He has a Masters Degree in Mathematics; is an ASQ certified Biomedical Auditor, Quality Auditor, Quality Engineer, Reliability Engineer, and Six Sigma Black Belt; and is certified by APICS in Resource Management.

Topic Background:

When you make a change to a cleared device, some regulations come into play. They include all the elements of design change control, 820.30(i), including verification, validation, review, risk management, and the design history file. Because the evaluation of a significant change or modification in design, components, method of manufacture, or intended use is in Part 807, many companies miss it as part of design change.

Section 807.81 contains the requirements and the guidance document tells the manufacturer how to implement it. The guidance has flow charts that lead you through the analysis process by using decision points based on questions in the guidance. Generally, the flow chants will lead you to one of two decisions: document the analysis or file a new 510(k).
The specifications, performance, size, or composition of the device to an extent greater than the specified limits

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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 only 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."
For substitution, please email editor@complianceonline.com or call +1-650-620-3937.

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