Navigating the Maze for Post-Market Compliance -- Complaint Handling, MDRs, Recalls and Proposed Guidance on FDA Risk Benefits training seminars presented by ComplianceOnline register now on FindaSeminar.com

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Navigating the Maze for Post-Market Compliance -- Complaint Handling, MDRs, Recalls and Proposed Guidance on FDA Risk Benefits  

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

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Seminar Summary:

Medical Device Reporting (MDR), and Recall compliance are critical to the continue survival of all device manufacturers. (see full course description)

 

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Training Course Syllabus:


Navigating the Maze; Post-Market Compliance for Medical Devices and Evolving Reporting Requirements: Complaint Handling, MDR/eMDR and Recalls including UDI update: One and a Half-day In-Person Seminar by Ex-FDA Official

During the seminar, Ms. Hoffman will explain 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. She will also discuss 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 to Course will be creating Standard Operating Systems for Post-Market Quality Systems.

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. 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.

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

DAY 01(8:30 AM - 5:00 PM)
08.30 AM - 09.00 AM: Registration
09.00 AM: Session Start
Introduction to class (20 min)
Complaint Handling and FDA Expectations (70 min)
What is a complaint?
Firms Responsibilities and Definitions
Complaint Forms
FDA Expectations for written procedures on complaint files
Medical Device Reporting Procedures (MDR) (60 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
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)
Medical Products Safety Network (MedSun)
User Error Malfunction
Identifying a Malfunction
Malfunction --To report or not to report
Serious injury triggers
Person Qualified Makes Medical Judgment
Recalls: Definitions and Legal Authority (45 min)
What is a recall?
Legal Authority (Chapter 7, 21CFR 806)
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
Examples of Close-calls
Guidelines and best practices for having contingency plan in place
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

DAY 02(8:30 AM - 12:00 PM)

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
Silent Recalls vs. Product Enhancements (20 min)
Device changing environment
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
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)

Seminar Summary:

Medical Device Reporting (MDR), and Recall compliance are critical to the continue survival of all device manufacturers. (see full course description)

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