Dates/times:
Thursday, June 02 2016 at 08:30 AM (Get Tickets)
Location:
Richmond Marriott
500 E Broad St
Richmond, VA 23219
Event Description:
Post-Compliance Medical Device Regulations and Evolving Reporting Requirements: Complaint Handling, eMDR and MD Reporting, and Recalls and their compliance with UDI’s :2-Day In-Person Seminar
Location: RICHMOND, VA
Dates: 02-June-2016: 08:30 AM - 05:00 PM EST
03-June-2016: 08:30 AM - 03:00 PM EST
Venu:RICHMOND MARRIOTT
500 E BROAD ST. l RICHMOND, VA 23219
Speaker: Rita Hoffman
Rita Hoffman is the principal consultant for Regs & Recall Strategies, LLC, a consulting firm providing regulatory insight focusing on industry assistance on FDA compliance issues. Ms. Hoffman has been consulting with FDA firms on post marketing issues for the past 4 years. Prior to working as a consultant, Ms. Hoffman spent more than 36 years with the FDA. She retired in 2011 after holding the position of recall branch chief for the Center for Devices and Radiological Health (CDRH). She was responsible for oversight and review of all medical devices recalls with extensive knowledge of the legal authority of 21 CFR Parts 7 & 806, 803 and 820 of the Act.
Course Description:
This interactive 2-day course led by Ms. Rita Hoffman, Former FDA CDRH Recall Branch Chief, who has more than 36 years experience with the FDA and as a private consultant will provide the participants tools to minimize risk of regulatory enforcement actions.
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) and eMDR, 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 since a recall can be disruptive of a firm's operation and business, but there are several steps a firm can take in advance to minimize this disruptive effect including, required record keeping, 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.
Complaint Handling, 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.
Course Objective:
At the completion of the course, attendees will be able to:
Understand how to comply with complicated Complaint Handling, MDR and Recall requirements.
Firms MDR/eMDR 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.
Who Should Attend
This 2-day course is particularly relevant to managers, supervisors, and staff whose responsibilities related post-market issues with Medical Devices. Specific positions that will benefit:
Quality Assurance and Quality Control personnel responsible complaint handling, and recalls
Regulatory and Compliance professionals responsible for FDA interactions
Project Managers responsible for maintenance of Complaint Handling, troubleshooting, and understanding QSR
Risk Managers
CAPA Teams
Agenda:
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
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)
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Thank you & Regards,
Sean Sharpe,
Training Manager,
Call us at this Toll Free number: +1-866-978-0800