Two Day Event: Managing Your Complaints & Obstacles in Post-Market Requirements - Results from Top Medical Device Observations During an Inspection (Tampa, FL, United States - February 6-7, 2020)
DUBLIN, Dec. 16, 2019 /PRNewswire/ -- 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.
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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
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/4ga6ql
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