Medical Device Complaint Management 2015


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
    • CA&PA verification and validation
    • CA&PA effectiveness review
    • CA&PA 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.


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 five 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?
    • Is the design change an enhancement or a recall?
  • 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.


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
  • The link between C&R reports and recalls
  • Recalls caused by suppliers

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

4:30 p.m.

Adjourn Workshop



Day 1 | Day 2

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