Dates/times:
Thursday, January 28 2016 at 09:00 AM (Get Tickets)
Location:
DoubleTree by Hilton Hotel San Diego Downtown
1646 Front St
San Diego, CA 92101
Event Description:
Overview:
Does your Complaint Management system provide value to your company? It does if your company handles complaints efficiently and 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.
To help clarify the issues, the workshop includes FDA Warning Letters. These Warning Letters illustrate problems that other companies have had so you can avoid them. The workshop also includes hands-on exercises for practical applications.
Why should you attend?
In this two-day workshop you will understand all the processes and elements in a Quality Management System (QMS) that come to bear on effective Complaint Management. It starts with the definition of a complaint in FDA's Quality System Regulation (QSR) and ISO 13485:2003. (The complaint definitions are not the same.) In these systems a complaint has a specific technical meaning that is significantly different from the colloquial meaning.
Areas Covered in the Session:
Complaints can lead to investigations that lead to corrective action. The workshop explains how to investigate complaints and perform corrective action using the elements of your QMS. It helps establish the interfaces between these systems, designate individuals, assign responsibility, and assure the required skill set.
A complaint may represent a serious event reportable to regulatory authorizes. The workshop helps you understand the FDA reporting requirements for Medical Device Reports (MDRs) and the corresponding reports for the EU and Health Canada. Each of these systems has different definitions, thresholds, and time frames.
The corrective action may lead to design changes. Does the design control system handle these changes? Do you know how to evaluate the change for an updated 510(k)? How does the change affect the UDI? Documenting the change in a Technical File or Design Dossier is very important in the EU.
The corrective action may lead to a field action, potentially requiring a report to FDA. However, there are complex exceptions to the reporting requirements that may create a record, but not a report. The workshop will help you understand the requirements, establish regulatory timelines, and implement a compliant approach. In addition, handling field actions in the EU and Canada involves a different regulatory structure.
Complaints are an essential element for the post-production evaluation required by an ISO 14971:2007 (EN ISO 14971:2012) quality management system. You will learn how to update the risk management file and take action to reduce risk.
Who will benefit:
All levels of Management for all departments and those who desire a better understanding
QA/QC/Compliance/Regulatory Affairs
Marketing & Sales & Customer Service
Engineering/Technical Services
Consultants
Operations and Manufacturing
Agenda:
Day 1 Schedule:
Lecture 1:
The Regulatory Structure
The development of the QMS (QSR & ISO 13485)
The current versions of the QMS (US, EU, & Canada)
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 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
Complaints
Servicing
MDRs
International Implications
Lecture 3:
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 quality tools
Lecture 4:
Complaints
Definition of a complaint
QSR vs. ISO 13485 definitions
Establishing the complaint files
Designating individuals
Complaint system interrelationships
Complaints & CA&PA
Complaints & MDRs
Complaints and Risk Management (ISO 14971:2007)
Complaint system flowchart
Complaint records
Exercise - Analyze customer reports to determine if they are a complaint and potentially reportable
Lecture 5:
Medical Device Reports (US)
Criteria for reporting
Establishing the MDR event files
Designating individuals
MDR system interrelationships
MDRs & Complaints
Types of MDRs (30 day & 5 day)
Reporting MDRs
The eMDR System
Records required for the MDR system
Exercise - Initiate a Medical Device Report
Day 2 Schedule:
Lecture 6:
Medical device reports in the EU and Canada
Criteria for reporting
The regulatory structure in the EU (MDD and MedDev)
The regulatory structure in Canada
Role of the Notified Body
Role of the MDD Authorized Representative
Exercise - Analyze an adverse event to determine when to report and when
Lecture 7:
Corrective and Preventive Action (CA&PA)
Definitions
QSR definitions
ISO 9000:2005 definitions
The difference between corrective action (CA) and preventive action (PA)
CA&PA Interrelationships
The CA&PA flowchart
CA&PA verification and validation
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 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
Lecture 9:
510(k) Changes
When a design change requires a pre-market notification change
510(k) change process Interrelationships
Design change
Risk Management Process
510(k) change records and reports
The FDA guidance document
Exercise - Analyze design changes to determine if they require a 510(k)
Lecture 10:
Risk Management
The definition of risk
Determining acceptable risk
Establishing the Risk Management File
Collecting production and post-production information
Evaluating and acting on information
Linking risk evaluation to design changes
Exercise - Evaluate post-production information for changes to risk
Lecture 11:
Corrections and Removals (C&R)
Defining the terms
C&R Interrelationships
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
Speaker:
Dan O'Leary
President, Ombu Enterprises
Dan is the 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 Master’s 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.
Location: San Diego, CA
Date: January 28th & 29th, 2016 and Time: 9:00 AM to 6:00 PM
Price:
(Without Stay) Price: $1,295.00 (Seminar for One Delegate)
(With Stay) Includes Price: $1,695.00 (Seminar for One Delegate)
Register now and save $200. (Early Bird)
Until December 15, Early Bird Price: $1,295.00 from December 16 to January 26, Regular Price: $1,495.00
Until December 15, Early Bird Price: $1,695.00 from December 16 to January 26, Regular Price: $1,895.00
Quick Contact:
NetZealous BDA as GlobalCompliancePanel
Phone: 1-800-447-9407
Fax: 302-288-6884
Email: support@globalcompliancepanel.com
Website: http://www.globalcompliancepanel.com
Registration Link - http://bit.ly/Medical-Device-Complaint-Handling