Discounted tickets are available now!
New York Professional Events List
Complaints, Adverse Event Reporting, and Recalls - An Integrated Approach
Date
Link to Website
Organizer
Location
Medical Device manufacturers operate in numerous regulatory systems that often have different requirements and are not always consistent. The new ISO 13485:2020 emphasizes this problem. Manufacturers must identify their roles, identify the regulatory requirements for that role, and incorporate them into the quality management system.
The various jurisdictions, however, deal with post-market device issues in many different ways. The quality management system, QMS, needs three interlocking process: complaint management, adverse event reporting, and recalls. These processes also have supporting QMS processes such as corrective action and design changes. Overarching the QMS processes are the regulatory requirements, usually involving record keeping and reporting. This workshop covers these primary and secondary QMS processes and analyzes them in terms of US, EU, and Canadian regulations.
Why should you attend:
To have an effective and efficient QMS you need to understand how to implement the related QMS processes. Developing the processes involves implementing best practices, but that doesn't necessarily meet all the regulatory requirements. With the introduction of ISO 13485:2020, the Medical Device Single Audit Program (MDSAP), and the new EU Medical Device Regulation, you will need to update your QMS and integrate all of the elements to assure an effective and compliant implementation. This workshop provides the tools you will need.
Who will benefit:
- Quality Directors and Managers
- Regulatory Directors and Managers
- Design Engineering Managers
- Sustaining Engineering Managers
- Risk Managers
- Complaint Specialists
- Adverse Event Reporters
- Corrective Action Specialists
- Recall Specialists
Please contact the event manager Marilyn below for the following:
- For Registrations Please call +1 929.900.1853
- Discounts for registering 5 or more participants.
- If you company requires a price quotation.
Event Manager Contact: marilyn.b.turner(at)nyeventslist.com
You can also contact us if you require a visa invitation letter, after ticket purchase.
We can also provide a certificate of completion for this event if required.
NO REFUNDS OR TRANSFER ALLOWED ON REGISTRATIONS
-----------------------------------------------------------------
This Event Listing is Promoted by
New York Media Technologies LLC in association
with NetZealous LLC.
http://www.NyEventsList.com
http://www.BostonEventsList.com
http://www.SFBayEventsList.com
-----------------------------------------------------------------
JAI170516EVZTODAY
Agenda
Day 1 Schedule
The Regulatory Structure
FDA QSR
ISO 13485:2016 and regional variants
ISO 14971:2007 and regional variants
Implementing MDSAP
The EU Medical Device Regulation
Servicing
Identification of problems
Servicing data analysis
Input to the complaint process
Complaints
Identifying complaints
Evaluating complaints
Investigating complaints
Complaint data analysis
Input to the corrective action process
Input to the risk management process
Corrective Action
Developing the process
Analyzing product and process information
Determining subsequent actions
Input to the design process
Input to the risk management process
Design and Design Changes
Determining the need for a design change
Documenting design changes
Design change verification and validation
Input to the risk management process
Input to the pre-market submission process
Day 2 Schedule
Risk Management
ISO 14971:2007 and regional variants
Incorporating post-market information
Updating Pre-market Submissions
US - The 510(k) guidance
EU - Technical files and design dossiers
Canada - License changes
Adverse Event Reporting
US - MDR
EU - Vigilance Reports
Canada - Mandatory Problem Reporting
Recalls
US - Corrections and Removals
EU - Field Safety Corrective Actions
Canada - Recall
Speaker Details
Dan O'Leary
President, Ombu EnterprisesDan O'Leary is President of Ombu Enterprises, LLC, a company offering training and execution in Operational Excellence, focused on analytic skills and a systems approach to operations management. Dan has more than 30 years experience in quality, operations, and program management in regulated industries including aviation, defense, medical devices, and clinical labs. He has a Masters Degree in Mathematics; is an ASQ certified Biomedical Auditor, Quality Auditor, Quality Engineer, Reliability Engineer, and Six Sigma Black Belt; and certified by APICS in Resource Management.