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.
• 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
• 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