Course Description- Medical Device Reporting Training

This course on Medical Device Complaint Handling Training aims at providing a close understanding of MDR & recall compliance. It also deals in handling the interrelationship of Complaint Handling, CAPA, and Risk Administration procedures.

Post-Market activities, Grievance Handling, MDRs, and Recalls are luxurious, time-consuming, and often lead to graver monetary penalties. Over 80% of FDA Inspection target observations for lack of compliance in these areas.

By attending this seminar, every trainee will be able to find out and discover:

▪         Different ways to overcome one of the major hindrances device manufacturers encounters

▪         How the FDA expects you to grow and device proper handling of complaints reportable or non-reportable, product complaint management and certification

▪         How and when to file Medical Device Reports (MDR), actual and suitable message with the apt controlling agencies in the event of a recall.

▪         How to demeanor improvement and elimination actions to avoid a recall emergency, including required recordkeeping, anticipation from FDA and other monitoring agencies in the event of a recall, and crucial factors in applying and upholding compliance with the regulations and real-life experiences of FDA.

**New course materials have been added, and updated content now contains:

▪         Creating Standard Operating Systems (SOPs) for Post-Market Quality Systems and

▪         What to expect from the changes in ORA with Inspection Structure Realignment

This Seminar on Medical Device Reporting Training will have you stop spinning your wheels with supplementary actions, and leave you with a complete knowledge set that only WCS can provide.

Who are the possible beneficiaries of this course in Medical Device Reporting Training?

This course will bring clear benefits to anyone in the medical device industry that manages functions involving product complaints, recalls, and medical device reporting.

▪         CAPA Teams

▪         Quality Assurance

▪         Regulatory Affairs

▪         Risk Management Professionals

▪         Quality Control

▪         Project Managers

▪         Regulatory Professional

▪         Complaint Handling Teams

Agenda

Introduction (15 mins)

 

Session 1

▪         Grievance Management and FDA Prospects (90 mins)

▪         Break (15 mins)

 

Session 2

▪         Continuance Grievance Treatment and FDA Expectations (30 mins)

▪         Medical Device Reporting Procedures (MDR) Regulations, Procedures, and Malfunctions (60 min)

▪         Lunch Break (45 mins)

 

Session 3

▪         Continuation of Medical Device Reporting Events (MDR) Rules, Measures, and Malfunctions (60 min)

▪         MDR reporting by the firm, agents Voluntary Malfunction Summary Reporting (VMSR), and eMDR Discussion (30 min)

▪         Break (15 mins)

Session 4

▪         Guidance Documents Update (30mins)

▪         Being Recall Ready (30mins)

▪         Questions and Recap (10 mins)

 

Session 5

▪         Recalls, Definition, and Legal Authority Overview (60 mins)

▪         Corrective and Preventative Actions (CAPA) (30 mins)

▪         Break (15 mins)

 

Session 6

▪         Health Hazard Evaluations HHE/HRA (30 mins)

▪         Elements of a Correction and Removal -- 806 Reporting (45 mins)

▪         Lunch Break (45 mins)

 

Session 7

▪         Developing Effective Strategies / Communicating and Negotiating with FDA (45mins)

▪         Notifications Letters and Press Releases (20 mins)

▪         Silent Recalls / Product Enhancements and Enforcement Actions (20 mins)

 

Break (10 mins)

Session 8

▪         Product Retrieval (20 mins)

▪         Status Reports (20 mins)

▪         Effectiveness Checks Follow-up Planning (20 mins)

▪         Terminating a Recall (15 mins)

▪         Wrap-up (5 mins)

Objectives of Learning- Medical Device Reporting Training

▪         Knowledge of ways to comply with complex Complaint Handling, MDR, and Recall requirements

▪         Companies' MDR reporting and FDA's management of reports

▪         Company training in the event of a Recall, recall policy, notification letter, and interactive with the FDA

▪         Diminish the risk of controlling implementation activities

▪         Contribution to the creation and maintenance of real events for treatment complaints, reportable events, and recalls

▪         Comprehend the relationship and interaction with other quality system elements as they relate to complaints and reportable events

▪         Walk-through of case instances

▪         A step-by-step guide to designing Standard Operating Systems for communicating processes for the success of the firm

▪         Discussion of FDA’s New Guidance on Risk and how it interacts with Recalls

Medical Device Complaint Handling Training-Topic Background

Medical Device Reporting (MDR) and recall acquiescence are dangerous to the enduring existence of all device producers. The FDA is continuing its efforts to issue frequent FDA Warning Letters and grave implementation actions, including illegal & civil disadvantages levied on businesses 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 critical) recall has surged in the last three years. Furthermore, product responsibility and monetary risks are staggering when companies fail to appropriately report and take action when required.

It will be helpful to all device manufacturers and is optional for any individuals or teams that are involved in medical device reporting (MDR) and correction & removal processes, including recalls.

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FDA Faculty Rita Hoffman

Faculty Rita Hoffman

Managing Partner Regs & Recall Strategies, LLC and Former FDA CDRH Recall Branch Chief

Over 38 years with FDA in the area of compliance. For the past 10 years devoted to industry training and consulting in the area of compliance with regulations and response to FDA, recall, Complaint Handing, MDR/eMDR management, Field Safety Alerts for drug products and FDA remediation of enforcement actions primarily focused in medical devices, pharmaceuticals and combination products and Pharmacy Compounding. 


-Branch Chief, Recalls – 3 yrs., Ctr for Dev & Rad Hlth

-Regulatory Project Manager – 4 yrs., Ctr for Drug Evaluation l & Research (CDER)

-Acting Ombudsman– 6 mo., CDER

-Jurisdictional Officer/Compliance Officer, 18 yrs., CDER

-Consumer Safety Officer– 4.5 yrs., Ctr for Vet Med

-Policy Analyst - 7 yrs., Office of the Commissioner and Office of Regulatory Affairs (ORA)

Additional Experience:

-RAPS--Baltimore/Washington Chapter Leader 4 yrs. 

-FDA Small Business Liaisons 10 yrs.

FDA Consultant and Training Specialist – 10 yrs.

Ms. Hoffman, in addition to RAPS Certified, is the recipient of RAPS Special Recognition Award for her unique contributions and achievements of individuals and organizations that advance the quality of health and regulatory affairs. She served as co-chair of RAPS’ Baltimore/Washington Metropolitan Area Chapter for 2-terms, working in collaboration with both chapter members and FDA to increase professional awareness of regulatory issues. Mrs. Hoffman holds a BS from the University of Maryland and has received many additional awards from both government and industry including the FDA Distinguished Government Service Award.