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Complaint Handling in Compliance with FDA and ISO Regulations

Webinars - Complaint Handling in Compliance with FDA and ISO Regulations

By : Compliance Online

Date : 2012

Location : United States US / Palo Alto

Video 01h 09m
Description :

This webinar will show how you can handle customer complaints in compliance with FDA and ISO Regulations. We will discuss the best ways to document customer feedback, what constitutes a complaint, what do with "non-complaint" feedback, and how to include complaint trending into your firm’s CAPA.

Keywords :

Customer complaints, handling customer complaints, customer feedback management, customer complaint FDA regulations



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 include the requirements for defining, documenting, and implementing a complaint-handling system, including the requirements for complaint review, investigation, and corrective action, as well as the ISO-specific implications.


This complaint handling webinar 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.


Who Will Benefit:

This webinar will provide valuable assistance to all regulated companies, since complaint handling is a regulatory requirement across the Medical Device, Diagnostic, Pharmaceutical, and Biologics fields. The employees who will benefit include:

  • Regulatory management
  • QA management
  • Customer Service personnel
  • Sales personnel
  • Consultants
  • Quality System Auditors


Areas Covered in the Seminar:

  • 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.



Instructor Profile:


Jeff Kasoff, RAC, is the Director of Quality at Byrne Medical, a leading manufacturer of consumables and instrumentation in the endoscopy field. In this position, Jeff is responsible for oversight of the quality system, including phase approval of design history files. For the past 13 years, Jeff served as Director of Regulatory Affairs at Life-Tech, Inc., where he was responsible for corporate compliance. Jeff began his regulatory career as the first full-time employee of Optex Biomedical, a device start-up, where he initiated their regulatory policies and procedures and prepared their submissions. Jeff received his Regulatory Affairs Certification in 1996.


Recorded webinar and reference materials will be available on your account after purchase.

Complaint Handling in Compliance with FDA and ISO Regulations

Product Type : On Demand Webinar

Author : Jeff Kasoff

Video 01h 09m

Languages : English

Organizer : Compliance Online

ComplianceOnline is a Regulatory Affairs Professionals Society(RAPS) RA Professional Development Portal provider. ComplianceOnline is committed to enhancing the ongoing professional development of regulatory affairs professionals and other stakeholders through appropriate regulatory affairs learning activities and programs ComplianceOnline has agreed to follow RAPS-established operational and educational criteria