Global
CompliancePanel
Knowledge, a Way Forward…
2-day In-person Seminar:
Medical Device Complaint Handling Price Baltimore, MD (Without Stay) Price:
April 28th & 29th, 2016 9:00 AM to 6:00 PM
$1,295.00
(Seminar for One Delegate)
(With Stay) Price:
$1,695.00
(Seminar for One Delegate) Register now and save $200. (Early Bird)
Dan O'Leary President, Ombu Enterprises Dan is the President of Ombu Enterprises, LLC, a
**Please note the registration will be closed 2 days (48 Hours) prior to the date of the seminar.
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
Seminar Pricing Includes (With Stay)
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 is certified by APICS in Resource Management.
Google Nexus 7 Tablet 2 Days Stay
Overview
Pick-up and Drop Facility (Nearest Airport)
Does your Complaint Management system provide value to your
Break-Fast and Lunch
company? It does if your company handles complaints efficiently and
High Tea
effectively - taking them through the reporting, classification, investigation, corrective action, and design change phases. Your system is effective if it recognizes the requirements to report to regulatory agencies (such as FDA, the EU, and Health Canada) and ensures you make the reports on time. An integrated system addresses multiple elements:
Designated individuals and their required skill sets
Procedures to define the process and standardize work
Records to maintain and their prescribed content
Reports to file with regulatory agencies and their timeframe
The workshop covers all of these elements and includes checklists to help you integrate them into your QMS.
Pack of 3 Webinars will be provided which has been done in the past on similar subject
2-day In-person Seminar:
Global
CompliancePanel
Medical Device Complaint Handling
Why should you attend:
Who will benet:
In this two-day workshop you will understand all the
All levels of Management for all departments
processes and elements in a Quality Management
and those who desire a better understanding
System (QMS) that come to bear on effective Complaint Management. It starts with the definition of a complaint in
QA/QC/Compliance/Regulatory Affairs
FDA's Quality System Regulation (QSR) and ISO
Marketing & Sales & Customer Service
Engineering/Technical Services
technical meaning that is significantly different from the
Consultants
colloquial meaning.
Operations and Manufacturing
13485:2003. (The complaint definitions are not the same.) In these systems a complaint has a specific
Agenda: Day One
Continue...
Lecture 1:
Lecture 4:
The Regulatory Structure
Complaints
The development of the QMS (QSR & ISO 13485)
Definition of a complaint
The current versions of the QMS (US, EU, & Canada)
QSR vs. ISO 13485 definitions
Establishing the complaint files
Designating individuals
Complaint system interrelationships
Records and their content Reports to regulatory agencies (content, trigger, and timing)
FDA Inspections and the guiding documents
Quality System Inspection Technique
Compliance Program 7382.845 Inspection of
Complaints & CA&PA
Complaints & MDRs
Complaints and Risk Management
Medical Device Manufacturers
Exercise - FDA Inspection Levels
Exercise - QSIT sampling plans for records
Lecture 2: Unique Device Identification
An overview of UDI
Recording and Reporting UDI
(ISO 14971:2007)
Complaint system flowchart
Complaint records
Exercise - Analyze customer reports to determine if they are a complaint and potentially reportable
Lecture 5:
Complaints
Servicing
Criteria for reporting
MDRs
Establishing the MDR event files
Designating individuals
MDR system interrelationships
International Implications
Lecture 3:
Medical Device Reports (US)
Servicing
Definition of servicing
Relationship to other QMS elements
Service Records and Service Reports
Service Record analysis (some tools and techniques)
Exercise - Analyze a small set of service records using
Types of MDRs (30 day & 5 day)
Reporting MDRs
quality tools
MDRs & Complaints
The eMDR System
Records required for the MDR system
Exercise - Initiate a Medical Device Report
2-day In-person Seminar:
Global
CompliancePanel
Medical Device Complaint Handling
Day Two
Continue...
Lecture 6:
Lecture 9:
Medical device reports in the EU and Canada
510(k) Changes
Criteria for reporting
When a design change requires a pre-market
The regulatory structure in the EU notification change
(MDD and MedDev)
510(k) change process Interrelationships
The regulatory structure in Canada Role of the Notified Body
Design change
Role of the MDD Authorized Representative
Risk Management Process
Exercise - Analyze an adverse event to determine
510(k) change records and reports
when to report and when
The FDA guidance document
Exercise - Analyze design changes to determine if
Lecture 7: Corrective and Preventive Action (CA&PA)
they require a 510(k)
Definitions
QSR definitions
ISO 9000:2005 definitions
Lecture 10: Risk Management
The difference between corrective action (CA) and
The definition of risk
preventive action (PA)
Determining acceptable risk
CA&PA Interrelationships
Establishing the Risk Management File
The CA&PA flowchart
Collecting production and post-production information
CA&PA verification and validation
Evaluating and acting on information
Linking risk evaluation to design changes
Exercise - Evaluate post-production information for
CA&PA effectiveness review
CA&PA records
Complaint analysis (some tools and techniques)
Exercise - Analyze complaints as quality data to identify quality problems
Lecture 8: Design Changes
Understand the role of change in the design control
changes to risk Lecture 11: Corrections and Removals (C&R)
Defining the terms
C&R Interrelationships
system
Design Change interrelationships
The Design Change flow chart
Design change records
Linking design changes to process changes
Design change records
Exercise - Classify a changes as a design change or a production process change
CA&PA
Design changes
Enhancements
C&R records and reports
Linkage to recalls
Exercise - Evaluate proposed field actions to determine if they are a correction or a removal
2-day In-person Seminar:
Global
CompliancePanel
Medical Device Complaint Handling
What You will get
Group Participation
10%
2 Attendees to get offer
20%
3 to 6 Attendees to get offer
25% 30%
1
Learning Objectives
2
Participation certiďŹ cates
3
Interactive sessions with the US expert
4
Post event email assistance to your queries.
5
Special price on future purchase of web
7 to 10 Attendees to get offer 10+ Attendees to get offer
Payment Option
based trainings.
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Credit Card: Use the Link to make Payment by Visa/Master/American Express card click on the register now link
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Special price on future consulting or expertise services.
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Check: Kindly make the check payable to NetZealous DBA GlobalCompliancePanel and mailed to 161 Mission Falls Lane, Suite 216,
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GlobalCompliancePanel.
Fremont, CA 94539, USA
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PO: Please drop an email to support@globalcompliancepanel.com or call the
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Special price on future seminars by
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Seminar Kit – includes presentation handout,
our toll free +1-800-447-9407 for the invoice and
ID card, brochure, trainings catalog, notepad
you may fax the PO to 302 288 6884
and pen.
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Networking with industry's top notch professionals
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Kindly get in touch with us for any help or information.
Fremont, CA 94539, USA
Look forward to meeting you at the seminar
NetZealous LLC, DBA GlobalCompliancePanel
Toll free: +1-800-447-9407 Fax: 302 288 6884 Email: support@globalcompliancepanel.com
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