Medical Device Complaint Handling: Solving Your Toughest Reporting Problems

Instructor: Dennis Moore
Product ID: 701192
  • Duration: 60 Min

recorded version

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

Training CD

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


Read Frequently Asked Questions

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.

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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