Medical Device Complaint Management

Conference

Medical Device
Complaint Management

Waltham, MA (Boston) • March 11-12, 2014

Agenda

 

DAY ONE: TUESDAY, MARCH 11

8:00 a.m. – 9:00 a.m.

REGISTRATION AND CONTINENTAL BREAKFAST

9:00 a.m. – 10:15 a.m.

Part A – The Intersection of Complaints and the Regulatory Structure

  • Understanding the Quality Management System (QMS) in the US, EU and Canada
  • Distinguishing records and reports to regulatory agencies (content, trigger, and timing)
  • How and why the FDA conducts inspections and the guiding documents they use
    • Quality System Inspection Technique
    • Compliance Program 7382.845 Inspection of Medical Device Manufacturers
  • Using sampling plans as part of the Medical Device Directive (MDD) audit

Exercise – FDA Inspection Levels
Exercise – QSIT sampling plans for records

10:15 a.m. – 10:30 a.m.

Break

10:30 a.m. – 12:00 p.m.

Part B – How Newly Enacted Unique Device Identification Will Impact Complaints

  • Overview of the US regulations regarding UDI
  • What are Device Identifiers and Production Identifiers — and how do they differ?
  • Understanding the GUDID and the information you need to supply

Exercise – Creating a new Device Identifier

Part C – Servicing:  The Front Line for Complaints?

  • Definition of servicing — is your definition and regulators’ the same?
  • How servicing relates to other QMS elements
  • Producing service records and and linking them to complaints
  • Tips, tools and techniques for analyzing service records; what should you be looking for?

Exercise – Analyze a small set of service records using quality tools

12:00 p.m. – 1:00 p.m.

Lunch Break

1:00 p.m. – 2:30 p.m.

Part D – Complaints

  • Definition of a complaint — distinguishing regulatory complaints from customer service complaints
  • Comparing and contrasting QSR vs. ISO 13485 definitions
  • Successfully developing and managing complaint classification systems
  • Fully understanding complaint system interrelationships; it’s harder than it appears
    • Complaints  and corrective action
    • Complaints  and MDRs
    • Complaints and EU Vigilance
    • Complaints and risk management (ISO 14971)
  • Complaint system flowchart
  • Determining the required content for complaint records

Exercise – Analyze customer reports to determine if they are a complaint and potentially reportable

2:30 p.m. – 2:45 p.m.

Break

2:45 p.m. – 4:30 p.m.

Part E – Medical Device Reports (US)

  • Understanding the criteria for reporting
  • Establishing the MDR event files that serve their purpose and stand up to FDA scrutiny
  • Identifying Designated Individuals
  • MDR system interrelationships
  • Examining the nexus between MDRs and complaints
  • Getting to know the types of MDRs (30-day and 5-day)
  • Reporting MDRs — proven strategies that work for all companies
  • Records required for the MDR system — what you must have

Exercise – Initiate a Medical Device Report

Part F – Medical Device Reports in the EU and Canada

  • Understanding the criteria for reporting
  • The regulatory structure in the EU (MDD and MedDev)
  • The regulatory structure in Canada
  • Role of the Notified Body in the Vigilance System
  • Role of the MDD Authorized Representative in the Vigilance System

Exercise – Analyze an adverse event to determine when to report

4:30 p.m.

SESSION WRAP-UP, END OF DAY ONE

DAY TWO: WEDNESDAY, MARCH 12

8:30 a.m. – 9:00 a.m.

CONTINENTAL BREAKFAST

9:00 a.m. – 10:15 a.m.

Part G – Corrective Action and Preventive Action (CA&PA)

  • The difference between corrective action (CA) and preventive action (PA)
  • Understanding CA&PA interrelationships in the QMS
  • The CA&PA flowchart —implementing it in your QMS
    • CAPA verification and validation
    • CAPA effectiveness review
    • CAPA records — opening, closing and managing the records effectively
  • Tips, tools and techniques for complaint analysis; what should you be looking for?

Exercise – Analyze complaints as quality data to identify quality problems

10:15 a.m. – 10:30 a.m.

Break

10:30 a.m. – 12:00 p.m.

Part H – Design Changes

  • Understand the role of change in the design control system
  • Design change interrelationships — the four important considerations
    • When a production change is a design change
    • Does the design change create a new Device Identifier?
    • Does the design change require an updated 510(k)?
    • Does the design change impact the Risk Management File?
  • The design change flow chart shows the picture
  • Design change records —tips for maintaining the Design History File (DHF)

Exercise – Classify changes as a design change or a production process change

12:00 p.m. – 1:00 p.m.

Lunch Break

1:00 p.m. – 2:30 p.m.

Part I – 510(k) Changes

  • When a design change requires a pre-market notification change
  • 510(k) change process interrelationships
  • 510(k) change records and reports
  • FDA’s 1997 guidance document — 17 years old, but still applicable today
  • The 2012 law and FDA’s plan — what’s the latest and what’s on the horizon

Exercise – Analyze design changes to determine if they require a revised 510(k)

2:30 p.m. – 2:45 p.m.

Break

2:45 p.m. – 4:30 p.m.

Part J – Corrections and Removals (C&R)

  • Defining the terms — a source of constant confusion
  • Understanding how the C&R regulations relate to the QMS
  • Distinguishing enhancements from recalls — the FDA guidance and its theory
  • C&R records and reports — distinguishing between the requirements
  • Overview of the integrated system and how to make it work for you
  • Bringing all the pieces together — best practices for building C&R procedures that work

Exercise – Evaluate proposed field actions to determine if they are a correction or a removal

4:30 p.m.

ADJOURN WORKSHOP