Bad Things Happen, But It Can Get Worse - Understanding FDA Post Market Regulations


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You can participate in an interactive course led by Ms. Rita Hoffman, former FDA CDRH Recall Branch Chief and Casper Uldriks, former Associate Director of CDRH. They will explain how participants can mitigate the risk of regulatory enforcement actions; avoid future recalls by using the Total Product Life Cycle TPLC paradigm that CDRH uses.

Discover how to overcome one of the biggest obstacles device manufacturers face, developing and implementing the proper handling of complaints, complaint filings under the Medical Device Reports (MDR) regulation and effective action with other state and federal public health and regulatory The seminar will cover how to conduct a correction and removal actions so you can void a recall crisis due to key factors that you face in real life experiences of FDA.

Course materials include creating Standard Operating Systems for Post-Market Quality Systems, how risk guidance document intertwines with Recalls and ORA Inspection Realignment Structure.

This Seminar will have you stop spinning your wheels with nonessential activities, and leave you with a comprehensive learning package that has only been offered by Casper Uldriks and Rita Hoffman, who bring over 68 years of combined experience.

Learning Objectives:

  • Learn about the FDA's agency-wide legal and procedural steps and investigational operations for post market issues
  • Understand how to comply with complicated Compliant Handling, MDR and Recall requirements
  • Firms MDR reporting and FDA's handling of MDR 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:

Post Market compliance for a Medical Device firm are expensive, time consuming and can lead to serious financial consequences. Customer satisfaction plays a significant role in measuring a product’s postmarket performance. It is an indicator of how effective the product performance is managed. Both the quality system regulation (QSR) and the International Organization for Standardization (ISO) require procedures and processes to monitor and control your post market problems. The complaint-handling mechanism not only collects feedback from unsatisfied customers, but also provides means for failure investigations and subsequent corrective and preventive actions (CAPA).

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

Recalls involve regulatory obligations, such as Post-Market regulations, complaint handling, Medical Device Reports, and a required report to the FDA under the Corrections and Removals regulation. Those are the easy issues to understand, in reality, it is much more complicated. Over 80% of FDA Inspections target observations for lack of compliance in these areas.

DAY 01(8:30 AM - 4:00 PM)
  • 08.30 AM - 09.00 AM: Registration
  • 09.00 AM: Session Start
  • Introduction to class (20 min)
  • New ORA Alignment and Inspection Changes (30 min)
  • What to expect during Inspection (60 min)
  • Complaint Handling and FDA Expectations(90 min)
  • Medical Device Reporting Procedures (MDR) Procedures and Regulations (60 min)
  • MDR reporting by firm, agents and exemptions (30 min)
  • MDR FDA Perspective and MedSun (30 min)
  • User Error/Malfunction (30 min)
  • FDA’s Legal Basis for Recalls and Enforcement (30 min)
  • FDA’s Agency Wide Recall Investigation Procedure (60 min)
  • End of Day Close-out Discussion (15 min)
DAY 02(8:30 AM - 4:00 PM)
  • FDA's Agency-wide Standard Regulatory Procedures (60 min)
  • Recalls: Definitions and Legal Authority for CDRH (45 min)
  • Risk Based Guidance Documents Effecting Recalls (30 min)
  • Preparing Standard Operating Procedures(20 min)
  • Correction Action or Preventative Action Plan and Determining Root Cause Analysis (CAPA) (45 min)
  • Alternatives to Reports of Corrections and Removals (15 min)
  • Being Recall Ready - Proactive Steps to Avoid Management Crisis (45 min)
  • Evaluating Risk and Health Hazard Evaluation (HHE) (60 min)
  • Developing effective Strategies and Communicating with FDA Field Experts (90 min)
  • Silent Recalls vs. Product Enhancements(20 min)
  • Negotiating and Meeting with FDA(30 min)
  • End of Day Close-out Discussion (15 min)
DAY 03(8:30 AM - 4:00 PM)
  • Recap from Days 1 & 2 (30 min)
  • Device Software Cybersecurity (60 min)
  • Software enterprise systems and assignment of recall responsibility (15 min)
  • Notification Letters and Press Releases (45 min)
  • Product Retrieval Issues, Effectiveness Checks and Status Reports (50 min)
  • Termination of a Recall (15 min)
  • Recall Follow Up & Voluntary destruction (30 min)
  • Retrospective Assessment (15 min)
  • FDA Follow Up Planning (60 min)
  • FDA's Use of Recall Data (30 min)
  • Mock Recall and Wrap-up (35 min)
Seminar (Price/Register)
Seminar Fee Includes:
Lunch
AM-PM Tea/Coffee
Seminar Material
Attendance Certificate
$100 Gift Cert for next seminar

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