Managing Your Complaints and Obstacles in Post-Market Requirements: Results from Top Medical Device Observations During an FDA Inspection (Tampa, FL, United States - February 6-7, 2020) - ResearchAndMarkets.com
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
Updated content will include:
Creating Standard Operating Systems (SOPs) for Post-Market Quality Systems
What to expect from the changes in ORA with Inspection Structure Realignment
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
Agenda:
Day 1
Registration
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)