Medical Device Complaint Handling: Solving Your Toughest Reporting Problems


Instructor: Dennis Moore
Product ID: 701192

  • Duration: 60 Min
This Medical device training will review the sections of the QS Reg. Complaint handling rules and will help you avoid FDA 483’s and warning letters.
Last Recorded Date: Feb-2009


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Read Frequently Asked Questions

Many companies are confident that their complaint handling systems are compliant to the Quality System Regulation, yet FDA conducts an inspection and FDA 483 complaint handling cites are written and warning Letters, seizures or worse ensue. This presentation will review the sections of the QS Reg. Complaint handling rules. Actual field complaint/FDA data will be discussed, and trends from FDA will be discerned from the data. FDA investigator techniques regarding complaint handling investigations will also be discussed.

Areas Covered in the seminar:

  • What processes are key in producing a compliant Complaint Handling System?
  • QSIT audit processes regarding CAPA/Complaint sytem investigations.
  • How do I counteract a possible FDA 483 cite?
  • Where does risk management fit in?
  • How do I correct the FDA compliance gaps in my complaint handling process?
  • How do I better audit my complaint handling systems?
  • How do I train my staff in complaint management compliance?

What Will Students Learn:

  • How do I answer an FDA 483 cite?
  • What type of resource commitment is there achieve complaint handling compliance?

Who will benefit:

This webinar will provide your firm with key insights on how to identify compliance gaps in your complaint handling processes. The webinar will help you avoid FDA 483’s and warning letters the employees who will benefit include:

  • Regulatory Managers
  • QA Managers and employees
  • Government Auditors
  • Quality System Auditors
  • Industry Consultants
  • ISO 13485:2003 auditors

Instructor Profile:

Dennis M. Moore, is the President CEO and Founder of AUK Technical Services LTD (ATS). a worldwide consulting firm which specializes in Quality Systems and submissions for medical device and pharmaceutical companies. Mr. Moore is a former 22 year FDA credentialed Government investigator, Retired Peace Officer and author of many articles on quality system concepts. Mr. Moore has performed hundreds of FDA device and drug inspections, and written many FDA 483 and warning letter citations. He also has industry experience on the manufacturer side of the auditing desk.

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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. On-Demand Recording purchases will not be refunded as it is available for immediate streaming. However if you are not able to view the webinar or you have any concern about the content of the webinar 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 [email protected] call +1-888-717-2436 (Toll Free).




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