September 05, 2024
01:00 PM ET | 12:00 PM CT
60 Mins
Donald Hurd
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Complaint management is hard.  Nobody *really* wants to deal with complaints and those whiners (and there certainly are some!).  But it’s a key aspect in the medical device regulatory landscape.  Besides just dealing with “negativity” associated with complaints, complaint management requires resources (personnel and time).  Companies want to be focused on revenue generation and often view complaints as overhead.  As a result, “newbies” are often assigned the task of managing complaints which leads to ineffective evaluations, lost opportunity, and frequent regulatory findings.  Further, with the mindset that it’s overhead, resources aren’t provided – both in terms of support personnel and time.  Complaint investigation naturally requires a level of product expertise that these “newbies” frequently do not have, and management does not want to pull the experts from development work to properly support the investigation.

Companies should be viewing complaint management as an opportunity for improvement.  Complaints must be properly investigated to determine where improvements can be made – both in terms of product and process.  Often, root causes of complaints can be traced back to a process deficiency; for example, user needs are not properly considered, formative studies are neglected in lieu of rapid development, testing is “crunched” because of schedule pressures, etc.

In this webinar, we’ll talk about the current state of the industry, how we got here, and what we can do to improve.  There are some specific issues that are common in industry that need to be considered to ensure a robust complaint management system.  We’ll look at each of these issues and discuss the means to resolve them. 

We’ll start with a quick review of terminology.  It’s always good to establish consistent understanding of terminology to ensure common understanding as we go further into the discussions.  We’ll also look briefly at the requirements outlined in the common standard (ISO 13485) and the US FDA regulation (21 CFR 820 – as tailored following adoption of ISO 13485). 

We’ll go into the sources of complaints – and it’s not always obvious!  We’ll discuss where companies normally get complaint data and where companies should be looking for complaint data.  Even the FDA notes that service information should be considered as a complaint source.  We’ll list the various sources and how to incorporate that data into complaint management.

We’ll delve into proper documentation for complaints and discuss considerations of trending and how trending is necessary to drive improvements.  Proper documentation is one of the keys to ensuring

We’ll touch on what it means to investigate and how to best ensure investigation is complete.  We’ll touch on some of the common means to determine root causes.

We’ll then discuss some of the potential actions that can be taken and the importance of maintaining a linkage between actions taken and the complaint.  We’ll note how actions identified are often a cause of noncompliance!  We’ll discuss the importance of ensuring closure

We’ll discuss trending and how trending should be used.

We’ll then wrap up with an overview of the issues normally seen and summarize the means to avoid them then finish with a summary of key points

Webinar Objectives

  • Establish a common understanding of the terminology and requirements for complaint management
  • Review the sources of complaints and consider some that are often overlooked
  • Establish the basics for complaint documentation
  • Discuss investigating complaints
  • Identify root cause(s)
  • Taking and managing actions
  • Trending
  • Issues and how to avoid

Webinar Agenda

  • Overview of the state of complaint handling in industry
  • Impact of FDA adoption of ISO 13485 (with their re tension of complaint documentation)
  • Review of terminology
  • Overview of complaint sources
  • Documenting complaints
  • Categorizing complaints
  • Investigating complaints
  • Potential actions that may be taken
  • Trend analysis

Webinar Highlights

  • Where are we now
  • What is driving how we do complaint management
  • Where should we look for complaints
  • How we should document complaints
  • What we should do to investigate complaints
  • How to determine root causes
  • How to manage actions arising from complaints
  • What the common issues are and how to avoid them

Who Should Attend

  • Hopefully, management representatives will participate to understand the importance of assigning appropriate resources and allowing ample time for complaint management.
  • Individuals working in complaint management can benefit to get an overview of the process and consider how their work can be improved.
  • Quality personnel will benefit to understand concepts behind the process and ensure processes are being implemented to ensure compliance and to effect improvement.
  • Project managers can benefit to understand how complaint management can be used to improve product and processes.


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Donald Hurd

Don Hurd has over 40 years of experience in supporting development of applications in regulated industries, the last 22 in medical devices. With his diverse background, Mr. Hurd provides a unique insight into driving product quality and ensuring high productivity of development organizations.  Mr. Hurd is currently the Vice President of Quality and Validation Services for The Realtime Group, a contract R&D firm specialized in serving the regulated industries, primarily medical devices.  In this role, Mr. Hurd led the company to certification in both ISO 9001 and ISO 13485, maintaining certification for nearly 20 years.  In his role at Realtime, Mr. Hurd supports clients...

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