Managing Medical Device Recalls – Awareness Course

Description

A medical device recall is a method of removing or correcting products that are in violation of laws administered by the regulatory body in the market where the product is sold. Recall is a voluntary action that takes place because manufacturers and distributors carry out their responsibility to protect the public health and well-being from products that present a risk of injury or gross deception or are otherwise defective. This course aims to provide guidance for managing a medical device recall so that responsible firms may conduct an effective recall.

Who Should Attend?

• Quality & regulatory professionals
• Manufacturing, product development & design engineers
• Marketing Product Managers
• Complaint handling personnel
• Clinical affairs personnel
• Site managers, and consultants
• Contract manufacturing organization
• Contract research organization
• Senior and executive management
• Anyone involved in the design, development, manufacturing, distribution, trading, sales or marketing of medical devices

Key Benefits

• Understand regulatory requirements on medical device recall  in various countries across world
• Learn common mandatory requirements for device recalls
• Learn how to interact with regulatory bodies
• See how to develop health risk determinations
• Learn critical recall strategy components
• Learn  how to classify medical device recalls
• Learn to effectively manage a medical device recall
• Understand the difference between a Medical Device Recall, Market Withdrawal, and Safety Alert
• Identify  the problem and root-cause of the recalling product
• Learn to develop effective Standard Operating Procedures (SOPs) for recalling your product
• Learn the common mistakes companies make when recalling products
• Learn how to implement a corrective action program for a recall
• Learn the documentation and record keeping practices
• Understand the communication requirements during medical device recall
• Learn to assign roles and responsibilities to manage a medical device recall
• Learn to conduct mock recalls

Learning & Evaluation Method

This is  a live and interactive course.  Once you purchase the course, our team will contact you to plan the training. No matter where you are located, we schedule the classes based on your convenience and time zone. You can plan to attend the training in sessions of 4 or 8 hr duration, based on how much time you can spend in a day.

Buy for group Are you planning to buy this course for a group? We have the best prices for you! Select ‘Buy for Group’ option and add to the cart. You will get a discount of 60 – 75% for a group of up to 10 participants. To make a group purchase, create your group name and add individual emails of up to 10 participants. Each participant will get the access to the course materials, exam and the certificate. We will arrange one live-online session for the entire group.