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Complaints, MDRs & Recalls Workshop

February 11, 2020 to February 12, 2020
701 Pennsylvania Avenue #800, Washington, DC

Led by industry and FDA experts, this workshop will provide an in-depth overview of how organizations can best tackle complaints, MDRs and recalls. Together with industry and FDA experts, we've developed a program designed to provide you with insights and strategies that you can immediately implement at your organization.

Workshop topics will include:

  • Complaints: Definitional questions
  • Setting up a complaint system
  • Handling complaints & trending
  • Recalls and other field actions
  • Understanding MDRs
  • An introduction to Health Hazard Evaluation (HHE)
  • Reporting and products liability
  • Part 806 reports of removals and corrections
  • Current FDA inspection and enforcement trends
  • Measuring the effectiveness of your complaint system
  • Recall procedures
  • Communicating with FDA - before, during and after a recall
  • Crisis management
  • Creating a recall strategy

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Feb 11, 2020

8:30 – 9:00 am

Registration and Continental Breakfast

9:00 – 9:05 am

Welcome and Introductions

9:05 – 10:00 am

Defining Complaints
Mike Heyl, Hogan Lovells
Ted Wilson, Hogan Lovells

  • Distinguishing among product complaints, satisfaction complaints, customer inquiries, and service calls
  • Differentiating instrument repairs and complaints

10:00 – 10:45 am


Elements of an Effective Complaint Management System
Youssef Halas, GE Healthcare

  • Risk management influences on complaint handling decisions
  • Determining primary lead for complaint management system
  • Role of service and sales calls within complaint handling procedures
  • Training and Motivating Service and Sales personnel to identify and report complaints
  • Responsibilities of other departments
  • Maintenance of files: Who, Where, How long
  • Relationship to CAPA system

10:45 – 11:00 am


11:00 – 12:00 pm

Handling Complaints & Trending
Mike Heyl, Hogan Lovells
Ted Wilson, Hogan Lovells

  • Importance of establishing a process for handling complaints
  • Example SOPs for sorting out potential MDRs and product complaints
  • Steps FDA expects to see a company taking to address potential MDRs, product complaints and other reportable events
  • How to perform trending
  • Examples of trending and analysis of service calls and product complaints
  • FDA’s expectation for trending complaints from non-US markets

12:00 – 1:00 pm


1:00 – 2:00 pm

Understanding MDRs
Steven Niedelman, King & Spalding

  • Key terms, definitions and forms
  • Investigating complaints, determining if they are MDRs
  • Identifying reportable malfunctions vs MDRs
  • MDR flow chart
  • Conducting risk assessments
  • When not to report an incident
  • MDR reports and reporting under 21 CFR Part 806
  • Managing international reporting requirements under your complaint handling system
  • Summary Reporting
  • Alternative reporting mechanisms

2:00 – 2:45 pm

An Introduction to Health Hazard Evaluation (HHE)
Allison Fulton, Sheppard Mullin

  • Health Hazard Evaluation defined
  • When HHE should be initiated
  • Elements of a well-documented HHE
  • Common mistakes
  • How HHEs are documented and approved
  • Maintaining records
  • FDA’s involvement in HHE and classification

2:45 – 3:00 pm


3:00 – 3:30 pm

Reporting and Products Liability
Kathryn Klaus, Medmarc

  • Implications of incorrect reporting; impact on products liability

3:30 – 4:15 pm

Current FDA Inspection & Enforcement Trends
Neil Mafnas, FDA

  • FDA perspective on post-market issues and field actions
  • Current enforcement trends
  • FDA inspectional activities
  • FDA expectations for the industry

4:15 – 5:15 pm

Measuring the Effectiveness of Your Complaint System
Allison Fulton, Sheppard Mullin

  • Maintaining an appropriate complaint handling system in a risk-based post-market environment
  • Auditing a complaint handling system
  • Using audits to determine whether your complaint handling system is effective
  • Ensuring the electronic records database handling complaints complies with 21 CFR Part 11
  • Performing and documenting a failure investigation
  • Investigating complaints when samples are not available/product is not returned
  • Employee guidelines for how and when to respond to customer complaints
  • Obtaining and managing data

5:15 – 6:15 pm

Networking Reception

Feb 12, 2020

8:30 – 9:00 am

Continental Breakfast

9:00 – 9:45 am

Recalls: Definitions, Practices, and Current FDA Perspective
Maureen Bernier, FDA

  • Defining Recalls
  • Relationships between MDRs, Corrections, Removals, and Recalls
  • Recall trends
  • Voluntary vs. mandatory recalls
  • Corrections, removals, market withdrawal, stock recovery, and routine servicing
  • Reporting requirement exemptions
  • Recall classification
  • FDA expectations

9:45 – 10:45 am

Part 806 Reports of Removals and Corrections
Maureen Bernier, FDA

  • Key elements of 21 CFR Part 806
  • Examples of items that need to be reported
  • Filing an 806 if you have a recall or advisory notice
  • Information to be reported
  • Types of records to be maintained
  • Steps to take prior to notifying FDA
  • Dos and don'ts when informing FDA of a product problem
  • Strategy for removals and corrections vs recalls

10:45 – 11:00 am


11:00 – 12:00 pm

Recall Procedures
Tony Blank, Infinity Biomedical Group

  • Necessity of a team
  • Pivotal nature of the regulatory affairs function during a recall
  • Recall Procedures – How it works in the best of all possible worlds
    • Hypothetical example of a voluntary recall in which everything takes place perfectly according to plan.  Defines the sequence of events, interaction between FDA-industry-distributors-purchasers-physicians-patients, and the rationale for each step
  • Recall Procedures – What happens in the real world
    • Hypothetical example of a voluntary recall plagued by all of the confusion, uncertainty, disagreements, conflicting interests, mistakes, miscommunications, and other problems that occur

12:00 – 1:00 pm

Networking Lunch

1:00 – 2:00 pm

Mobilizing and Deploying a Field-Based Team During a Recall

  • Deployment plan
  • Logistics of affected plan
  • Time requirements
  • Team deployment
  • Analytics on: products updated/remediated/shipped back, serial number management and cost management of field-based team

2:00 – 3:00 pm

Communicating with Your Team and FDA Before, During and After a Recall
Dorothy Henckel, Navigant

  • Communication with FDA
  • Reporting recalls through 21 CFR Parts 7 and 806
  • Tools available from FDA
  • Recall vs. Enhancement guidance
  • Individual(s) responsible for communicating with the FDA
  • Priorities to keep in mind when developing an internal communications plan
  • Customer and other outside communications
  • Priorities to keep in mind when developing a field team communications plan
  • Documentation to include on the notification letter
  • Effectiveness check defined
  • Writing your recall correspondence
  • Determining that your recall is completed

3:00 – 3:15 pm

Networking Break

3:15 – 4:15 pm

Regulatory and Business Considerations When Developing a Recall Strategy 
Ginger Glaser, Monteris Medical

  • Elements of a recall strategy
  • Examples of robust recall strategies, anecdotes of deficiencies
  • Effective contingency plans – who, what, where, when, how
  • Product identification issues
  • Product distribution records
  • Auditing internal recall procedures
  • Communicating your strategy effectively to FDA
  • Global considerations

4:15 – 4:45 pm

Case Study: Lifecycle of a Recall
Ginger Glaser, Monteris Medical

4:45 pm

Meeting Adjournment

Speakers include:

  • Mike Heyl, Hogan Lovells
  • Ted Wilson, Hogan Lovells
  • Youssef Halas, GE Healthcare
  • Steven Niedelman, King & Spalding
  • Allison Fulton, Sheppard Mullin
  • Kathryn Klaus, Medmarc
  • Neil Mafnas, FDA
  • Allison Fulton, Sheppard Mullin
  • Maureen Bernier, FDA
  • Tony Blank, Infinity Biomedical Group
  • Dorothy Henckel, Navigant
  • Ginger Glaser, Monteris Medical

The Complaints, MDRs & Recalls Workshop will take place February 11-12 at the AdvaMed Office in Washington, DC.

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701 Pennsylvania Ave. N.W.
Suite 800
Washington, D.C.

Registration Fees

AdvaMed Member Registration: $1395.00

Accel Member Registration: $695.00

Government and Non-Profit Registration: $695.00

Non-Member Registration: $1,895.00

Note: Early-bird pricing is available for AdvaMed Members and Non-Members. Register by January 25, 2020 for $200 off your registration!