Complaint Handling Best Practices – Compliance with FDA and ISO Regulations

03:00 PM ET | 12:00 PM PT | 14:00 PM CT Duration 60 Minutes

Webinar Includes : All the training handouts , Certificate by the Speaker ,Q/A and 60 Min Live Webinar

"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"

How do you let your customers know that you received their complaint


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. 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 the application of risk management to a complaint handling system, and a specific risk management system explained.

Objectives of the Presentation

•      Understand what FDA and ISO complaints are
•      What are the FDA and ISO requirements for complaints
•      What are the documentation requirements
•      What are the reporting requirements

Why Should you Attend

Many complaints include terminology that is unlikely to withstand an FDA or ISO audit, such as "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 one of its supports, a robust complaint system that is both compliant and business-savvy. This webinar will address these issues and more.

Further, unlike many complaint management trainings, 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 form on which to document risk.

Areas Covered

•      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
•      Customer reply: benefits, detriments, and recommended practices

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:

•      Customer Service (i.e., 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

Industries who can attend

This 60-minute online course is intended for professionals in the Medical Device, Biotechnology,Pharmaceutical Industry. Although not presently stated in the draft , the same guide could be used by FDA Regulated Industries personnel

Speaker Profile

Jeff Kasoff

FDA Speaker, Quality and Regulatory Consultant

Jeff Kasoff 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.

Jeff Kasoff, RAC, CMQ/OE 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 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.

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