Complaint Management: Best Practices to Assure Regulatory Compliance and Customer Retention
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 the 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. He is also a certified internal auditor for MDSAP, ISO 13485:2016, and EU MDR, from Exemplar Global.
This session will include the requirements for all required cross-functional 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.
This webinar contains a streamlined review of the regulations, allowing the majority of time to be spent on a detailed focus on critical process requirements for compliance with the regulations. Jeff will also call from his 30+ years of experience in this area to put forth recommendations for methods of documentation that are straightforward and compliant. Among these recommendations are contents of complaint records, root cause investigations, and corrective actions. This webinar also covers the application of risk management principles to a complaint investigation.
- 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
Course Level - Intermediate
Who Should Attend
- Customer Service (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
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 maybe the dreaded “What did you find out?” A compliant quality system has, as one of its supports, a robust complaint system that is both compliant and business-savvy. This webinar will address these issues and 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!