Complaints, MDRs & Recalls Workshop

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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

Break

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

Lunch

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

Break

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

Break

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
TBD

• 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