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A Unified Approach to Complaints, Servicing, and FDA Reporting

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This webinar will provide practical information on the FDA requirements for complaints, but expands the traditional scope to include closely linked, but often overlooked processes. It will explore the problems that can trigger FDA reports such as Medical Device Reports (MDRs), Corrections Reports, and Removals Reports. On the servicing side, the course will detail the requirements to analyze service reports, show how they can trigger MDRs, and automatically become complaints. This webinar will minimize the use of regulatory language and easily illustrate how participants can implement an effective and unified system. As an added bonus, the webinar will include information on the UDI rule and the eMDR rule.

Instructor: Daniel O Leary
Product ID: 701455
Training Level: Intermediate to Advanced

Why Should You Attend:

This course will provide attendees with the information needed to implement an effective system for managing and reporting adverse events. The webinar instructor will break down the regulatory requirements in a simple format, and describe them using common quality tools such as flow diagrams and fault tree analysis for better comprehension of the regulations.

Further, the instructor will provide complete descriptions of the interlocking systems that the FDA requires you to implement. These systems include:

These requirements are spread across multiple parts of the FDA regulations, so they are not always implemented in unison. The presentation will unite the systems to make their implementation easier and more effective. Participants will learn when written procedures are required, when (and how) to name designated individuals, when (and how) to formally designate units, what records you must keep, and when you must report to the FDA.

Other key illustrations include statistical techniques that can be used to analyze corrective actions and service reports. These include histograms, scatter plots, check sheets, Pareto charts, and cause-and-effect diagrams. Because these regulations may also span your organizational structure, this webinar is especially suited for cross functional and cross discipline teams.

Learning Objectives:

Areas Covered in the Webinar:

Who Will Benefit:

Instructor Profile:

Daniel O'Leary is the president of Ombu Enterprises, LLC, a company offering training and execution in operational excellence, focused on analytical skills and a systems approach to operations management. Mr. O'Leary 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 master’s 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:

The FDA continues to focus on post-market surveillance. One of the leading Warning Letter citations is failure to implement an effective complaint management system. In addition, complaints can lead to MDRs, Corrections, and Removals. Warning Letters often cite failures, or even no implementation, of these other systems. Firms don’t always create a unified approach, because these related systems are not in Part 820, QSR. As a result, they may be misunderstood or ignored.

The best approach to an FDA inspection is to understand and implement the regulations. You must understand the full set of regulations so you can cover all the requirements. The FDA has stringent requirements for reporting, so people who may impact the timeline need to understand the requirements. This webinar will give you the tools and techniques you will need to avoid receiving an FDA 483 or Warning Letter in this area.

If your Quality Management System (QMS), through its documented procedures, cannot answer these question quickly, and without hesitation, then you, and your team need to attend this webinar:

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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.

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Training Options Training Duration = 90 Min
$229.00 Access Recorded Version Only
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Recorded Link and Ref. material will be available in My CO Section
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CD and Ref. material will be shipped within 15 business days