Medical Devices Post Market Surveillance Online Course: Product Complaints Management, Medical Device Reporting, Vigilance Reporting, Product Recalls (July 29, 2022)
Dublin, July 01, 2022 (GLOBE NEWSWIRE) -- The "Medical Devices - Post Market Surveillance: Product Complaints Management, Medical Device Reporting, Vigilance Reporting, Product Recalls" training has been added to ResearchAndMarkets.com's offering.
This course will provide practical guidance and real-life examples that will help you develop and/or optimize your company's post market surveillance system. It is essential to have an effective, efficient and robust medical device post market surveillance system.
These are key elements for early identification and rapid response to problems with marketed products. In addition to the obvious need to comply with regulatory requirements, it is also vital from a business standpoint to understand the importance of complaint management, MDR's, vigilance reporting, and product recalls. A robust post market surveillance system helps to prevent unnecessary patient injuries, reduces the chances for financial loss, and it could result in improved products.
Complaint management, MDRs, EU vigilance reporting, and product recalls are top priorities in FDA and notified body inspections. For example, 40% of all FDA Warning Letters are related to issues involving the complaint management system. Additionally, four recent Warning Letters issued by the FDA involved issues related to MDRs.
This interactive seminar will focus on:
Complaint Management
Medical Device Reporting (MDR)
EU Vigilance Reporting
Product Recalls
Learning Objectives :
Key goal of this course is to understand:
Legal authorities (statutes and regulations) and definitions applicable to key elements of Post Market Surveillance (Complaint Management, MDRs, Vigilance and Product Recalls)
Regulatory and compliance requirements related to each element of Post Market Surveillance (Complaint Management, MDRs, Vigilance and Product Recalls)
Implementing applicable processes and procedures for Complaint Management, MDRs, Vigilance and Product Recalls
Management review and dissemination of Post Market Surveillance information
What to do when a complaint is received:
What/how/when to investigate a complaint
Contents of records of complaint investigation
How to adjudicate the complaint
Implementing interactive systems between complaint handling, medical device reporting, and CAPA
Submission of MDR's to the FDA:
What/how/when to submit an MDR
Contents of the reporting form
Utilizing MDR information as qualitative data
Submission of Vigilance Reports to EU Competent Authorities:
What/how/when to submit a Vigilance Report
Contents of the reporting form
What to do when a medical device needs to be recalled:
What/how/when to initiate a medical device product recall
Contents of the recall reports and records
Recall execution and closure
To discussion of key case studies and how to prevent compliance issues related to Complaint Management, MDR, Vigilance reporting and medical device product recalls
To review the key concepts and implementation steps for an effective Post Market Surveillance system
Time: 9:00 AM - 4:30 PM PDT
Who Should Attend:
Anyone that participates in product complaint management, medical device reporting, vigilance reporting, and/or product recalls:
Regulatory Affairs Personnel
Quality managers and those working in sales or marketing
Legal Personnel
Compliance Professionals
Clinical affairs specialists and those handling complaints
Medical Affair Professionals
Design Control Managers
Risk Managers
July 29, 2022 (9:00 AM to 4:30 PM PDT)
Registration Process: 8:30 AM - 9:00 AM
9.00 - 10.30: The Basics of Quality System Regulations and Post Market Surveillance Activities
Regulatory Overview
General Provisions of the Regulation
Quality Management
Monitoring and Feedback
Purpose of Risk Management
10.30 - 11.30: Product Complaint Management
What is a complaint?
Why do we collect product complaints
Management of product complaints
Developing a complaint management procedure
Analyzing product complaint data
Effective utilization of product complaint data
11.30 - 12.30: Medical Device Reporting
Review of the MDR regulation
Sources of MDRs
Submission MDRs (initial and follow up)
Effective utilization of MDR data
12.30 - 01.30: Lunch
01.30 - 02.45: Medical Devices European Vigilance Reporting
Review of the reporting requirements
Submission of Vigilance reporting forms
Proper completion of the Vigilance reporting form
Dealing with Notified Body and Competent Authorities
02.45 - 04.00: Medical Device Recalls
Review of the regulation
What is a recall?
Other action types
Utilizing internal resources
Recall records
Coordinating with regulatory agencies
Closing out a product recall
04.00 - 04.30: Questions and Answers
Speakers:
Prof. Dr. h.c. Frank Stein
Senior Medical Device Expert
Nemius Consulting GmbH
Dr. h.c. Frank Stein, medical engineer, medical engineering experience since 25 years, clinical and research experience in cardiac surgery and cardiology, industrial experience in ophthalmology, neurology, traumatology and dental implants, active implants, active devices, international project and regulatory consulting experience in Europe, North-America, Asia, Australia, Arabic Countries, Latin-America.
For more information about this training visit https://www.researchandmarkets.com/r/8wiarb
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