Upcoming Events at Will be Announced Soon
Thu Oct 18, 9:00 AM - Fri Oct 19, 6:00 PM
Will be Announced Soon
Washington, Washington, DC 22202
Community: Upper West Side
Description
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.
Event Details
Description:
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.
Learning Objectives:
This seminar 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 seminar also covers the application of risk management principles to complaint investigation
Why you should attend:
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
• Consultants
• Quality system auditors
Agenda:
Day 1 Schedule
Lecture 1: Introduction
Lecture 2: Complaint Handling
• Regulatory Overvie
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.
Learning Objectives:
This seminar 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 seminar also covers the application of risk management principles to complaint investigation
Why you should attend:
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
• Consultants
• Quality system auditors
Agenda:
Day 1 Schedule
Lecture 1: Introduction
Lecture 2: Complaint Handling
• Regulatory Overvie
