Complaint Handling Best Practices – Compliance with FDA and ISO Regulations

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. Also, discussed will be 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 of 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.

Why You Should Attend:

This session’s streamlined review of the regulations enables detailed focus on recommended contents of complaint records and root cause investigations. Methods for trending of complaints are included, as well as forms on which to document risk.

Most complaints include terminology that is unlikely to withstand an FDA or ISO audit, such as “product didn’t work,” “isolated occurrence” and “low risk.” Further, from a business perspective, how do you let your customers know that you received their complaint when you know that their next question may be the dreaded “What did you find out?” A compliant quality system has, as one of its supports, a robust complaint system that is both compliant and business-savvy. This webinar will address all of these issues and more.

Areas Covered in the Session :

  • FDA and ISO requirements for complaint handling
  • Establishment of complaint handling program
  • What constitutes a complaint
  • “Non-complaints”
  • The roles of investigation and corrective action in complaint handling
  • Complaint trending and reporting
  • Application of risk management to complaint handling program
  • Benefits/Detriments of a Reply to the Customer
Who Should Attend:

  • Regulatory Management
  • QA Management
  • Customer Service Personnel
  • Sales Personnel
  • Consultants
  • Quality System Auditors

FDB2531

Jeff Kasoff

Jeff Kasoff, RAC, CMQ/OE, LBB, is the Principal at Lean to Quality, LLC. He has more than 30 years in Quality and Regulatory management. Over that time, Jeff has implemented and overseen quality system operations and assured compliance, at all sizes of company, from startup to more than $100 million in revenue. This multi-faceted experience makes Jeff uniquely qualified to address compliance issues across the entire range of company sizes.

Jeff has also been primary liaison with FDA inspectors and notified body auditors, giving him first-hand experience with the most common issues surfaced by regulatory agencies. Jeff has the following certifications: Manager of Quality and Organizational Excellence certification from ASQ, Regulatory Affairs Certification from RAPS, and Lean Black Belt from IIE.

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  • Login Information with Password to join the session, 24 hours prior to the webinar
  • Presentation Handout in .pdf format
  • Presentation from the Speaker
  • Feedback form
  • Certificate of Attendance
  • Recording access Information with Password to view the webinar, will be sent 24 hours after the completion of the Live webinar.
  • Presentation Handout in .pdf format
  • Certificate of Attendance
.