Complaint Handling in Compliance with FDA and ISO Regulations

  • Friday
  • April
  • 30
  • 2021
Time:
12:00 PM PDT | 03:00 PM EDT
Duration:
60 Minutes
Jeff Kasoff Instructor:
Jeff Kasoff
Webinar Id:
50515

More Trainings by this Expert

Price Details
$149 Live
$299 Corporate Live
$199 Recorded
$399 Corporate Recorded
Combo Offers
Live + Recorded
$299 $348 Live + Recorded
Corporate (Live + Recorded)
$599 $698 Corporate
(Live + Recorded)
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Overview:

Negative customer feedback about a medical device's performance or safety is a strong indicator of whether a firm's manufacturing process is in control. This feedback is therefore subject to many requirements in both the QSR and ISO 13485. Failure to follow up on complaints about medical devices is among the most frequently cited observations on FDA-483s.

This session will discuss the best way to document customer feedback, what constitutes a complaint, and what do with "non-complaint" feedback. Also contained will be a suggested method on including complaint trending into your firm's CAPA program. Additionally, the application of risk management to a complaint handling system will be reviewed, and a specific risk management system explained.

Areas Covered in the Session:

  • FDA and ISO requirements for complaint handling
  • Establishment of complaint handling program
  • What constitutes a complaint
  • ISO-specific implications of complaint handling
  • The roles of investigation and corrective action in complaint handling
  • Complaint trending and reporting
  • Application of risk management to complaint handling program

Who Will Benefit:
  • Regulatory Management
  • QA Management
  • Customer Service Personnel
  • Sales Personnel
  • Consultants
  • Quality System Auditors


Speaker Profile
Jeff Kasoff, RAC, is the Director of Quality at Byrne Medical, a leading manufacturer of endoscopy and colonoscopy devices, where he oversees the operation of the quality system. In this position, Jeff is responsible for oversight of the document control system, including maintenance of regulatory documentation. Prior to this, Jeff spent 13 years at Life-Tech, Inc. as the Director of Regulatory Affairs, where he was responsible for compliance of the corporate quality system. Jeff received his regulatory affairs certification in 1996.


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