Medical Device Complaint Handling:
Building An Integrated Approach For Your Company
WORKSHOP AGENDA
Instructor: Dan O'Leary, President, Ombu Enterprises, LLC
Return to Previous Page
Day One: Thursday, May 03, 2012
Registration and Continental Breakfast
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
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
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)
- Complaint system flowchart
- Complaint records
- Exercise – Analyze customer reports to determine if they are a complaint and potentially reportable
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
- Records required for the MDR system
- Exercise – Initiate a Medical Device Report
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
Day Two: Friday, May 04, 2012
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
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
- Exercise – Classify changes as a design change or a production process change
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)
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
Corrections and Removals (C&R)
- Defining the terms
- C&R Interrelationships
- C&R records and reports
- Overview of the integrated system
- Bringing all the pieces together
- Exercise – Evaluate proposed field actions to determine if they are a correction or a removal Summary