ONLINE WEBINAR 2017 - Post-Compliance Medical Device Regulations and Evolving Reporting Requirements: Complaint Handling, Medical Device Reporting/ eMDR and Recalls and their compliance with UDI's

Website https://www.onlinecompliancepanel.com/workshop/POST-COMPLIANCE-MEDICAL-DEVICE-UDI-s-800020/JULY-2017 | Edit Freely

Category Medical Device Regulations, Recall Compliance, Reporting Requirements, complaint handling and documentation, Medical Device Reports, MDR, eMDR, MDR reporting, Final FDA's Guidance's, strategy, notification letter and communicating with the FDA.

Deadline: July 19, 2017 | Date: July 20, 2017-July 21, 2017

Venue/Country: Aloft Minneapolis, 900 Washington Avenue South Mi, U.S.A

Updated: 2017-06-22 20:53:19 (GMT+9)

Call For Papers - CFP

Conference Day One (8:30 AM - 5:00 PM)

Registration Process: 8:30 AM - 9:00 AM

Session Start: 9:00 AM

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

Discussion on 2016 Final Guidance

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)

eMDR Final Rule (45 min)

Final Rule

What is eMDR System

Highlights of Process

Options

Steps for acceptance of submission

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

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

Afternoon Wrap-up (30 min)

Conference Day Two (8:30 AM -3:00 PM)

Corrective and Preventive Action System (CAPA) (30 min)

What is a CAPA?

Essentials of and Effective System

Investigation and Steps to finding Root Cause

Root Cause Analysis

Elements of Correction and Removal Report (806.10) (50 min)

What must be reported

Construction of 806.10 Report

UDI information

How to provide Missing Information

Exemptions, Expanded Recall

Recordkeeping and Retention

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 Releases (45 min)

Firm’s Requirements

Common Mistakes

Constructing a Clearly Formatted Notification

Follow-up Communications

Silent Recalls vs. Product Enhancements and Enforcement by FDA (30 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)

Note: Use Promo code CG6KF and get 10% off on registration (Valid till JULY 31st 2017)