Complaint and Recall Management: A Compliant, Lean Program


Oct 18, 2018 – 9:00 AM - 6:00 PM

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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
Day 1 Schedule
Lecture 1: Introduction
Lecture 2: Complaint Handling
• Regulatory Overview: FDA, ISO 13485 (including 13485:2016)
• Definitions
• Application of Definitions
• The Value of "Non-complaints"
• Complaint Triage and Handling
• Complaint Investigations
• "Closing" Complaints
• Contents of Complaint Form
• Complaint Review and Trending
• Implementation of Risk Management into Complaint Handling
• Common Pitfalls and How to Overcome Them
• Exercise: Complaint or Non-complaint?
Day 2 Schedule
Lecture 1: Adverse Event Reporting
• Regulatory Overview: FDA, MDD
• MDRs
o Reporting Process
o Reporting Requirements
• Vigilance Reports
o Reporting Process
o Reporting Requirements
• Exercise: Reportability of Events
Lecture 2: Recalls / Field Corrective Actions
• Regulatory Overview: FDA, MEDDEV, Health Canada
o FDA Regulations
o EU Requirements
o Competent Authority Reportable Event
o Reporting Requirements
• Corrections and Removals
• Market Withdrawal and Stock Recovery
• Roles and Responsibilities
Lecture 3: Q&A – Conclusion

Jeff Kasoff
Director of Regulatory Affairs, Life-Tech, Inc
Jeff Kasoff, RAC, CMQ/OE, LBB is the Principal Consultant at Lean to Quality, LLC. He 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 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.

Location: Washington, DC Date: October 18th & 19th, 2018 and Time: 9:00 AM to 6:00 PM
Venue: Will be Announced Soon

Price: $1,295.00 (Seminar Fee for One Delegate)
Register for 5 attendees Price: $3,885.00 $6,475.00 You Save: $2,590.00 (40%)*
Register for 10 attendees Price: $7,122.00 $12,950.00 You Save: $5,828.00 (45%)*
Register now and save $200. (Early Bird)

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NetZealous LLC DBA GlobalCompliancePanel
Toll free: +1-800-447-9407
Phone: +1-510-584-9661

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Price: $1,295.00 (Seminar Fee for One Delegate) Register for 5 attendees Price: $3,885.00 $6,475.00 You Save: $2,590.00 (40%)* Register for 10 attendees Price: $7,122.00 $12,950.00 You Save: $5,828.00 (45%)* Register now and save $200. (Early Bird)

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