2 Day Course: Complaint and Recall Management - A Compliant, Lean Program - ResearchAndMarkets.com
DUBLIN--(BUSINESS WIRE)--Jun 6, 2018--The “Complaint and Recall Management: A Compliant, Lean Program” conference has been added to ResearchAndMarkets.com’s offering.
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.
Day 1 Schedule
Lecture 1: Introduction
Lecture 2: Complaint HandlingRegulatory 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 ReportingRegulatory Overview: FDA, MDD MDRs Reporting Process Reporting Requirements Vigilance Reports Reporting Process Reporting Requirements Exercise: Reportability of Events
Lecture 2: Recalls / Field Corrective ActionsRegulatory 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
For more information about this conference visit https://www.researchandmarkets.com/research/7gfx3s/2_day_course?w=4
View source version on businesswire.com:https://www.businesswire.com/news/home/20180606006127/en/
Laura Wood, Senior Manager
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Related Topics:Medical Devices
INDUSTRY KEYWORD: HEALTH MEDICAL DEVICES
SOURCE: Research and Markets
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PUB: 06/06/2018 01:11 PM/DISC: 06/06/2018 01:11 PM