Course Description

This course will provide an understanding of MDR & recall compliance and the interrelationship of Complaint Handling, CAPA, and Risk Management processes.

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.

**New course materials have been added, updated content will include:

  • Creating Standard Operating Systems (SOPs) for Post-Market Quality Systems and
  • What to expect from the changes in ORA with Inspection Structure Realignment

This Seminar will have you stop spinning your wheels with nonessential activities, and leave you with a comprehensive learning package that only WCS can provide.


DAY 01(10:00 AM - 3:00 PM EDT)

Introduction (15 mins)

Session 1

  • Complaint Handling and FDA Expectations (90 mins)

Break (15 mins)

Session 2

  • Continuation Complaint Handling and FDA Expectations (30 mins)
  • Medical Device Reporting Procedures (MDR) Regulations, Procedures, and Malfunctions (60 min)

Lunch Break (45 mins)

Session 3

  • Continuation of Medical Device Reporting Procedures (MDR) Regulations, Procedures, and Malfunctions (60 min)
  • MDR reporting by firm, agents Voluntary Malfunction Summary Reporting (VMSR) and eMDR Discussion (30 min)

Break (15 mins)

Session 4

  • Guidance Documents Update (30mins)
  • Being Recall Ready (30mins)
  • Questions and Recap (10 mins)

DAY 02(10:00 AM - 3:00 PM EDT)

Session 1

  • Recalls, Definition and Legal Authority Overview (60 mins)
  • Corrective and Preventative Actions (CAPA) (30 mins)

Break (15 mins)

Session 2

  • Health Hazard Evaluations HHE/HRA (30 mins)
  • Elements of a Correction and Removal -- 806 Reporting (45 mins)

Lunch Break (45 mins)

Session 3

  • Developing Effective Strategies / Communicating and Negotiating with FDA (45mins)
  • Notifications Letters and Press Releases (20 mins)
  • Silent Recalls / Product Enhancements and Enforcement Actions (20 mins)

Break (10 mins)

Session 4

  • Product Retrieval (20 mins)
  • Status Reports (20 mins)
  • Effectiveness Checks Follow-up Planning (20 mins)
  • Terminating a Recall (15 mins)
  • Wrap-up (5 mins)

Learning Objectives

  • Understand how to comply with complicated Complaint 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 Will Benefit

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

Topic Background

Medical Device Reporting (MDR) and recall compliance are critical to the continue survival of all device manufacturers. The FDA is continuing their efforts to issue numerous FDA Warning Letters and serious enforcement actions, including criminal & civil penalties levied on companies that failed to properly report events and take proper corrective and removal actions. The number of device companies having their recall classified as a Class 1 (most severe) recall has surged in the past three years. Additionally, product liability and financial risks are staggering when companies fail to properly report and take action when required.

It will be beneficial to all device manufacturers and is recommended for any individuals or teams that are involved in medical device reporting (MDR) and correction & removal processes, including recalls.

Rita Hoffman, RAC

Kelly Thomas (25+ year exp.)

Vice President, Americas Quality Operations at Stallergenes Greer - Charlotte Metro USA

Ms. Thomas has over two decades of cGMP hands-on industry experience in both pharmaceutical and medical device manufacturing operations. Her experience covers all Quality Systems; as well as, all areas of validation; including, process/product validation, facilities validation, CSV and 21 CFR Part 11, test method validation, equipment/automated processes and cleaning validation.  

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