Complaint Management: Best Practices to Assure Regulatory Compliance and Customer Retention
Duration : 60 Minutes
Jeff Kasoff,
Jeff Kasoff, RAC, CMQ/OE, Lean Black Belt, 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 unique Read more
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!
Course Objectives:
This session will include all requirements and responsibilities, which 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.
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
What You Get:
• Training Materials
• Live Q&A Session with our Expert
• Participation Certificate
• Access to Signup Community (Optional)
• Reward Points
Who Will Benefit:
• Your “complaint takers”
• Customer Service
• Regulatory personnel
• Quality Engineering personnel
• Sales and Marketing personnel
Customer Service personnel
• R&D personnel
• Manufacturing Engineering personnel
• Executive Management
• Consultants
• Quality system auditors
Please reach us at 1-888-844-8963 for any further assistance or if you wish to register
Contact Us
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