2-day In-person Seminar

Complaint File Management for Medical Device Manufacturers

January 28th & 29th, 2016

Time: 9:00 AM to 6:00 PM

San Diego, CA

Venue: Four Points By Sheraton San Diego Downtown

Director : Dan O'Leary
  (Without stay)   Price: $1,495.00
(Seminar Fee for One Delegate)

  (With stay)   Includes   Price: $1,895.00
(Seminar Fee for One Delegate)

**Please note the registration will be closed 2 days (48 Hours) prior to the date of the seminar.

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

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 guidingM 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:


  • 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:


  • 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
Seminar Pricing Includes (With stay)
asus-nexus7 Samsung Galaxy Tab 4
2 Days' Stay
Pick-up and Drop Facility (Nearest Airport)
Breakfast and Lunch
High Tea
Pack of 3 Past Webinars on similar subject
Group participations
Get fabulous discounts by participating in groups of two or more.
No Attendees Discount
1 2 Attendees 10% off
2 3 to 6 Attendees 20% off
3 7 to 10 Attendees 25% off
4 10+ Attendees 30% off

To avail the above group discounts, all the participants should register by making a single payment

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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 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.

Location: San Diego, CA Hotel: Four Points By Sheraton San Diego Downtown   1617 1st Avenue - San Diego, California, 92101 - United States

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