Best Practices in Lean Complaint Management in Compliance with FDA and ISO Regulations

Product Id : FDA28
Instructor : Jeff Kasoff
Jul 06, 2017 1:00 PM ET | 12:00 PM CT | 10:00 AM PT | 60 Minutes

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Overview

Best Practices in Complaint Management: Complaint Handling in Compliance with FDA and ISO Regulations

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 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 covered will be a discussion of the best way to document customer feedback, what constitutes a complaint, and what do with "non-complaint" feedback. The session will also highlight 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
  • 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 Will Benefit:

  • Regulatory management
  • QA management
  • Customer Service personnel
  • Sales personnel
  • Consultants 
  • Quality system auditors
  • Any personnel who may have direct interaction with FDA officials
Speaker Profile:

Jeff Kasoff, RAC, CMQ/OE has more than 30 years of experience 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 start-up 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 received his Regulatory Affairs Certification from RAPS, his Manager of Quality and Organizational Excellence certification from ASQ, and his Lean Black Belt from IIE.


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