Medical Devices – Effective Complaint Handling and Management

Teachers
Rita Hoffman
Category:
Med Device/Regulatory & Compliance/On Demand Courses/
2 Reviews
Clear
Duration: 90 Minutes
On-Demand
Includes handouts

Description

COURSE DESCRIPTION

OVERVIEW

There are many misconceptions on how to effectively manage and control medical device and in-vitro diagnostics product complaints using a coordinated, organized complaint handling system.  It is critical for manufacturers and healthcare providers to understand how to effectively handle these complaints to ensure patient safety and compliance mandates from regulatory agencies.  This course will examine and review FDA requirements and expectations in the handling of patient and provider concerns.  It will also review and discuss organizational requirements along with proven techniques to ensure effective management of complaints.

LEARNING OBJECTIVES

By attending this 90-minute session, you will learn:

  • The practical definition of a complaint – What is and what isn’t
  • How to navigate the sea of records, forms, and procedures
  • Triage – classifying complaints and understanding prioritization
  • Organizational responsibility for the complaint handling system
  • When to Report a complaint in accordance with 21 CFR Part 803
  • Complaint v Service – The difference between the two and how they interact
  • When to close a complaint file – corrective actions

Who Should Attend

WHO SHOULD ATTEND

This course will be of benefit to anyone involved in receiving customer complaints.  In particular quality assurance, sales, and marketing personnel will benefit from this course in helping to understand their responsibilities and roles in complaint management.

What To Expect

WHAT TO EXPECT

HOW TO PARTICIPATE

This webinar is offered on-demand. With your course purchase, you may view the previously recorded live session at your convenience (available for 30 days). Access to the on-demand webinar will be made available via email within 1 business day after your purchase. To access the course, you need only a computer with internet access and the log-in credentials.

THE TRAINING PLATFORM

Our webinar platform combines the convenience of online training with the live interactivity of the classroom. Quizzes, case studies, break-out sessions, and assessments are often incorporated into the training . Other ancillary materials can be downloaded from the “Handouts & Resources” area in the virtual classroom. Each course purchase includes a completion certificate issued to the participant after the course.

USER AGREEMENT

Your registration fee for a single participant entitles you to one telephone dial-in and one online course log-in per site. Course testing capabilities, stored results for training records, and completion certificates are available for only one registrant per single participant course purchase. For multiple participants, please purchase more than one registration or consider our 5 or 10 participant packages.

Is this course right for me? We’d be happy to help you select the right training course to meet your needs.
Give us a call at 215-675-1800 (9am – 5pm EST, M-F) for assistance.

About Instructors

Rita Hoffman
Extensive knowledge and experience in the application of FDA law, regulations, and policy, particularly as it relates to compliance and enforcement programs and strategy.

  • I am interested in the Medical Devices – Effective Complaint Handling and Management course. Is a certificate of completion provided at the end?

    • Hello David, Yes, a completion certificate will be provided after the post course survey is completed.

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