3-hour Virtual Seminar : Complaint Handling in Compliance with FDA and ISO Regulations



Speaker : Jeff Kasoff

Jeff Kasoff, RAC, is the Director of Quality at Medivators, a leading |  more...

Topic ID : 1361

Duration : 180 Mins

Attend Live Webinar
24-Apr-2017 : 1:00 PM EST

$ 299.00 Single Attendee

$ 599.00 3 to 5 Attendees
$ 799.00 6 to 10 Attendees
(For multiple locations contact Customer Care)


$ 599.00 Access Recorded Version online
Available for one viewer for 6 Months
(For multiple viewers, please contact Customer Care)

Recorded Link and Reference material will be available in My Account Section, 48 hrs after completion of Payment

$ 799.00 Buy Training CD-DVD
Recorded CD-DVD will be despatched after 72 hrs on completion of payment

Course Description:

Complaint handling is likely one of the more cross-functional parts of your quality system: Customer Service may receive your customer complaints, Sales and Marketing may need to reach out to the customer for additional information, Regulatory Affairs may determine whether the complaint is reportable, QA may perform the root cause investigation, R&D or Manufacturing Engineering may need to be involved in the corrective action, and Quality Engineering may need to trend the complaints! This session will include the requirements for all of the above responsibilities, which will include defining, documenting, and implementing a complaint-handling system, the requirements for complaint review, investigation, and corrective action, as well as ISO-specific implications.

Course Objective:

Also covered will be a discussion of what constitutes a complaint, and recommended practice on how to handle "non-complaint" feedback. Also covered will be a discussion on methods 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.

Course Outline:

  • FDA and ISO requirements for complaint handling
  • Establishment of complaint handling program
  • What constitutes a complaint
  • How to Handle “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
  • Reportability requirements and procedures

Target Audience:

  • Customer Service (your “complaint taker”)
  • Regulatory personnel
  • Quality Engineering personnel
  • Sales and Marketing personnel
  • Customer Service personnel
  • R&D personnel
  • Manufacturing Engineering
  • Executive Management
  • Consultants
  • Quality system auditors