Complaint and Recall Management: A Compliant, Lean Program (Boston, United States - July 26-27, 2018)

  • ID: 4555789
  • Conference
  • Location: Boston, United States
  • 2 Days
  • NetZealous LLC
  • Conference Dates: July 26-27, 2018
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"Complaint and Recall Management: A Compliant, Lean Program" Has Been Pre-Approved by RAPS as Eligible for Up to 12 Credits Towards a Participant's RAC Recertification Upon Full Completion

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 Should You 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
  • Executive Management
  • Consultants
  • Quality system auditors
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9:00AM - 6:00PM

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
  • Reporting Process
  • Reporting Requirements
  • Vigilance Reports
  • Reporting Process
  • Reporting Requirements
  • Exercise: Reportability of Events

Lecture 2: Recalls / Field Corrective Actions

  • Regulatory Overview: FDA, MEDDEV, Health Canada
  • FDA Regulations
  • EU Requirements
  • Competent Authority Reportable Event
  • Reporting Requirements
  • Corrections and Removals
  • Market Withdrawal and Stock Recovery
  • Recall Classifications
  • Roles and Responsibilities

Lecture 3: Q&A - Conclusion

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  • Jeff Kasoff Jeff Kasoff,
    Director of Quality ,
    Medivators


    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.

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  • Customer Service (your "complaint taker")
  • Regulatory personnel
  • Quality Engineering personnel
  • Sales and Marketing personnel
  • Customer Service personnel
  • R&D personnel
  • Manufacturing Engineering
  • Executive Management
  • Consultants
  • Quality system auditors
Note: Product cover images may vary from those shown
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ADDRESS

Four Points by Sheraton
Boston Logan Airport Revere,
MA 407 Squire Rd, Revere,
Massachusetts 02151, United States
Boston
United States


DIRECTIONS


DETAILS

A 6-mile drive from Boston International Airport, this modern hotel is 7 miles from the historic attractions of downtown Boston.
 
Bright, warmly decorated rooms include desks and flat-screen TVs with in-room movies, plus free Wi-Fi and bottled water. Upgraded rooms add minifridges and seating areas. Room service is available.
 
Freebies include a daily breakfast buffet, on-site parking, and an airport shuttle, as well as coffee. Other amenities include an indoor pool and a Japanese-themed steakhouse, plus a 24-hour business center and meeting rooms.

Note: Product cover images may vary from those shown
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