Complaint management is one of the most cross-functional parts of a quality system. Customer service may take the complaint, sales and marketing may contact the customer for details, regulatory affairs decides if it is reportable, QA investigates the root cause, R&D or manufacturing engineering may help with corrective action, and quality engineering trends the data.
This 60-minute complaint handling webinar sets out the FDA and ISO requirements behind each of those roles: defining, documenting and implementing a complaint handling system, and reviewing, investigating and correcting complaints.
It also explains what counts as a complaint, how to handle non-complaint feedback, how to apply risk management to complaint handling using a specific risk management system, and the pros and cons of replying to the customer.
Because complaints pass through so many departments, gaps in the process can lead to regulatory findings and lost customers. A clear, compliant system supports both regulatory compliance and customer retention.
This session helps everyone involved understand their responsibilities. It suits customer service, regulatory, quality engineering, sales and marketing, R&D and manufacturing engineering staff, executive management, consultants and quality system auditors.
Because complaints pass through so many departments, gaps in the process can lead to regulatory findings and lost customers. A clear, compliant system supports both regulatory compliance and customer retention.
This session helps everyone involved understand their responsibilities. It suits customer service, regulatory, quality engineering, sales and marketing, R&D and manufacturing engineering staff, executive management, consultants and quality system auditors.
Jeff Kasoff
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. 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 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 has the following …
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