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A Unified Approach to Complaints, Servicing, and FDA Reporting

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This FDA inspection training webinar provides practical advice on the FDA requirements for complaints. It explores the problems that can trigger FDA reports such as Medical Device Reports (MDRs), Corrections Reports, and Removals Reports. On the servicing side we explain the requirements to analyze service reports, show how they can trigger MDRs, and automatically become complaints.

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

As an added bonus, the webinar will include the newly proposed regulations for electronic filing of MDRs, the eMDR program

Why you should Attend:
The “new” FDA, under Dr. Hamburg, is increasing enforcement activities. The FDA districts are increasing the inspection frequency, meaning you are more likely to be inspected. The new rules on Warning Letters means you are more likely to be cited based on the observations from an inspection. The very best approach is to ensure you understand the requirements and have them fully implemented. You must understand the full set of regulations so you can cover all 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!.

This FDA compliance course provides the attendees with the information to implement an effective system for managing and reporting adverse events. We break down the regulatory requirements into plain English, and describe them using common quality tools such as flow diagrams and fault tree analysis. This approach helps you understand the essential parts of the regulations.

This compliance training will provide complete descriptions of the interlocking systems that the FDA requires you to implement. These systems include:Complaint Management, Medical Device Reporting, Corrections and Removals Management and Reporting, Corrective Actions, Corrective Action Statistical Analysis, Risk Management , Service Reports, Service Report Statistical Analysis.

As these requirements are spread across multiple parts of the FDA regulations, are not always implemented in unison. The presentation unites the systems to make their implementation easier and more effective.

You 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. You will see 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.

Areas Covered in the seminar:

Learning objectives:

The integration of multiple processes relating to adverse events can significantly improve a company’s regulatory compliance as well as reduce total cost. Participants will learn how to implement this integrated approach. You will see the regulations transposed to plain English, which will help you formulate your approach to full compliance. In addition, the presentation provides technical details, using common quality tools, to help you develop your procedures.

Who will benefit:

This seminar is designed for quality, regulatory, service, sales, and design people who may become involved in adverse events. In addition, Sales and Service employees are often the first to become aware of post-production problems. Design employees are often the first to recognize the need for field action. The FDA has stringent requirements for reporting, so people who may impact the timeline need to understand the requirements.

Attendees should understand service, problem reporting, corrective action, and field action processes. In addition, people in Sales or Service must recognize and report complaints or potential MDRs. Because of the cross functional and cross discipline aspects, this is an ideal opportunity for team attendance. You need to ensure that all parties get the same message. People in the following roles can especially benefit from the knowledge in this webinar:

Instructor Profile:
Daniel O'Leary, 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.

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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 or call +1-650-620-3937.

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Training Options Training Duration = 60 Min
$299.00 Access Recorded Version Only
One Person - Unlimited viewing for 6 Months
(For multiple licenses contact Customer Care)
Recorded Link and Ref. material will be available in My CO Section
$500.00 Get Training CD Only
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