Complaint and Recall Management: A Compliant, Lean Program
Course
In Boston (USA)
*Indicative price
Original amount in USD:
$ 1,495
Description
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Type
Practical seminar
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Level
Advanced
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Location
Boston (USA)
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Class hours
9h
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Duration
2 Days
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
Important information
Documents
- Complaint and Recall Management March 22-23 2018 PDF.pdf
Facilities
Location
Start date
Start date
About this course
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.
Complaint Handling is one of the more cross-functional aspects of your QMS, not to mention it being clearly the most customer-facing.
Reviews
Subjects
- Complaint and Recall Management
- Lean Program
- Omplaints and recalls
- Recall management
- Complaint handling system
- Risk management system
- Learn any professional courses
- Complaints and recalls slideshare
- Risk Management
- Regulations
Teachers and trainers (1)
Jeff Kasoff Jeff Kasoff
Director of Regulatory Affairs, Life-Tech, Inc
Jeff Kasoff, RAC, CMQ/OE has more than 30 years 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 startup 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 A
Course programme
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?
Adverse Event Reporting
- Regulatory Overview: FDA, MDD
- MDRs
- Reporting Process
- Reporting Requirements
- Vigilance Reports
- Reporting Process
- Reporting Requirements
- Exercise: Reportability of Events
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
Q&A - Conclusion
Additional information
NetZealous LLC DBA GlobalCompliancePaneljohn.robinson@globalcompliancepanel.com support@globalcompliancepanel.com Toll free: +1-800-447-9407Phone: +1-510-584-9661 Website: http://www.globalcompliancepanel.com
Registration Link - https://www.globalcompliancepanel.com/control/globalseminars/~product_id=901339SEMINAR?emagister
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Complaint and Recall Management: A Compliant, Lean Program
*Indicative price
Original amount in USD:
$ 1,495