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

The "Managing Your Complaints and Obstacles in Post-Market Requirements - Results from Top Medical Device Observations During an Inspection" conference has been added to ResearchAndMarkets.com'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

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)

• 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 https://www.researchandmarkets.com/r/c24ykv

View source version on businesswire.com: https://www.businesswire.com/news/home/20191210005770/en/