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, 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!
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. Attention will be paid to 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 complaint investigation.
- FDA and ISO requirements for complaint handling
- Establishment of complaint handling program
- What constitutes a complaint
- How to Handle “non-complaints”
- Root Cause Investigation
- CAPA Implications
- Establishment of KPIs and Best Practices for Tracking
- Complaint trending and reporting
- Application of risk management
- Customer Reply: Benefits, Detriments, and Recommended Practices
- Reportable Events: MDR, Competent Authority Event
- Reporting Requirements
- and more
Webinar Includes: All the training handouts, certificate, Q/A, and 3 Hrs Live.
Director of Quality ,
Jeff Kasoff, RAC, is the Director of Quality at Medivators, a leading manufacturer of endoscopy consumables and instrumentation. In this position, Jeff is responsible for oversight of the quality system, including the CAPA program, and is the liaison with FDA. For the previous 13 years, Jeff served as Director of Regulatory Affairs at Life-Tech, Inc., in which capacity he was similary responsible for quality system oversight. Jeff began his regulatory career as the first full-time employee of Optex Biomedical, a device start-up, where he initiated their regulatory policies and procedures and prepared their submissions. Jeff received his Regulatory Affairs Certification in 1996.
Complaint Handling is one of the more cross-functional aspects of your QMS, not to mention it being clearly the most customer-facing.
To that end, many different functions will benefit from this presentation:
- 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