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Two Day Seminar: Managing Your FDA Complaints and Obstacles in Post-Market Requirements (San Diego, United States - September 12-13, 2019)

DUBLIN, Aug. 28, 2019 /PRNewswire/ -- The "Managing Your Complaints and Obstacles in Post-Market Requirements - Results from Top Medical Device Observations During an Inspection" conference has been added to's offering.

Post-Market activities, Complaint Handling, MDRs, and Recalls are expensive, time consuming, and often lead to more serious financial consequences. Over 80% of FDA Inspection target observations for lack of compliance in these areas.

By attending this seminar, you will discover:

  • How to overcome one of the biggest obstacles device manufacturers face
  • How the FDA expects you to develop and implement proper handling of complaints reportable or non-reportable, product complaint handling and documentation
  • How and when to file Medical Device Reports (MDR), effective and appropriate communication with the appropriate regulatory agencies in the event of a recall.
  • How to conduct a correction and removal actions to avoid a recall crisis, including required recordkeeping, expectation from FDA and other regulatory agencies in the event of a recall and key factors in implementing and maintaining compliance with the regulations and real life experiences of FDA.

Learning Objectives:

  • Understand how to comply with complicated Compliant Handling, MDR and Recall requirements
  • Firms MDR reporting and FDA's handling of reports
  • Company preparation in the event of a Recall, recall strategy, notification letter and communicating with the FDA
  • Minimize your risk of regulatory enforcement actions
  • Assist with the creation and maintenance of effective procedures for handling complaints, reportable events and recalls
  • Understand the relationship and interaction with other quality system elements as they relate to complaints and reportable events
  • Walk-through of case examples
  • Step-By-Step guide to designing Standard Operating Systems for communicating process for firm's success
  • Discussion of FDA's New Guidance's on Risk and how it interacts with Recalls

Who Should Attend:

This course will benefit anyone in the medical device industry that handles functions involving product complaints, recalls, medical device reporting.

  • Regulatory Affairs
  • QA/QC
  • Project Managers
  • Regulatory Professional
  • Risk Managers
  • Complaint Handling Teams
  • CAPA Teams


Day 1


Session Start

Introduction to class (20 min)

Complaint Handling and FDA Expectations (120 min)

  • What is a complaint?
  • How do you distinguish among a product complain, a satisfaction complaint and a customer inquiry.
  • Firms Responsibilities and Definitions
  • Should companies document all service call complaints
  • Complaint Forms
  • FDA Expectations for written procedures on complaint files

Medical Device Reporting Procedures (MDR) (90 min)

  • Understand the MDR regulation 21CFR 803
  • Definitions 21 CFR 803.3
  • MDR Procedures 21 CFR 803.17
  • Types of MDR reports
  • MDR reporting by firm, agents and exemptions
  • Who should maintain files, how long should files be maintained
  • Final regulations on eMDRs
  • Identifying a Malfunction
  • Malfunction --To report or not to report
  • Serious injury triggers
  • Person Qualified Makes Medical Judgment

MDR FDA Perspective (30 min)

  • CDRH Mandatory vs. Voluntary Reporting
  • What happens to an MDR report submitted to FDA
  • Manufacturer and User Facility Device Experience (MAUDE) and new data system being implemented
  • Medical Products Safety Network (MedSun)
  • UDI requirements

eMDR (20 min)

  • Brief overview of eMDR (20 min)
  • Understanding Timelines for Reporting
  • Problems with eMDR

New Guidance Documents for Postmarket Regulations (30 min)

  • Case for Quality
  • Changes in Traditional Compliance Requirements
  • Emerging Signals
  • Scope of Evolving Guidance Documents
  • Benefit Risk Assessments
  • Notable Changes in FDA Thinking

Recalls: Definitions and Legal Authority (45 min)

  • What is a recall?
  • Legal Authority (Chapter 7, 21CFR 806)
  • What are the key elements of 21CFR 806
  • What information needs to be reported and when?
  • Voluntary vs. Mandatory recalls
  • Definitions - Corrections, Removals
  • Reporting requirements for non-recall field actions
  • Classification system - Classifying a Recall?
  • What is different about Class 1 recall

Being Recall Ready -Proactive Steps to Avoid Crisis (45 min)

  • Internal Decision Making
  • Early warning signs
  • Assembling The Team - Assigning decision making authority
  • Elements of an effective recall team
  • Responsibilities of other departments
  • Examples of Close-calls
  • Guidelines and best practices for having contingency plan in place

Day 2

Evaluating Risk and Health Hazard Evaluation (HHE) (60 min)

  • Analyzing adverse event and product quality reports
  • Identifying trends, Data and factors to consider
  • Assessing need to conduct HHE
  • HHE Procedures
  • Human Factors Issues
  • Opening a CAPA to Determine Root Cause and relationship to CAPA System

Elements of a Correction and Removal Report (806.10) (90 min)

  • Designing an 806 Report
  • Communicating with FDA
  • e 806 reporting
  • Expanding a C & R Report
  • Records/Exemptions

Developing Effective Strategies and Communicating with FDA (80 min)

  • Elements of a good Recall Strategy
  • What does the FDA expect strategy to contain?
  • Effective Notification Letter to minimize consequences
  • Knowing when to contact FDA District
  • Discussing Recall Strategy with FDA - Seeking input and support of your strategy to avoid common pitfalls
  • Issuance of Press Release and communication with customers

Notification Letters and Press Release (45 min)

  • Terminating a Recall
  • How and when does termination take place?
  • Communication between the firm and the District Office.
  • Requesting a formal recall closeout.
  • CAPA and finding the root cause (overview only)

Silent Recalls vs. Product Enhancements (30 min)

  • Device changing environment
  • Guidance Document and expectations
  • Product improvement (Repair or Modification)
  • Decision 803 or 806

Product Retrieval Issues, Effectiveness Checks and Status Reports (50 min)

  • Receiving and accounting for returned products
  • Supply chain challenges - distribution, wholesale, repackaging
  • Global recall market
  • Designing an efficient Effectiveness Checks
  • Coordination and Discussion with FDA
  • Evaluating recall effectiveness Data
  • Developing and formatting status reports

Changes in Inspections, Look-back from Recalls and Other Field Actions (30min)

  • What are the consequences of a recall?
  • How do you prepare for a post recall inspection
  • What customers and other outside communication are necessary?
  • What factors should you consider when determining whether or not to get your product back?
  • What to expect during inspection
  • How FDA has changes inspection (Who, What, How)

Termination of a Recall (15 min)

  • Who, how and when does termination happen
  • Exporting a Recalled Product
  • Communication between firm and District Office
  • Requesting formal closeout by FDA

Mock Recall and Wrap-up (35 min)

For more information about this conference visit

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