How to Manage a Medical Device Recall Efficiently and Effectively - By Compliance Global Inc.

Overview

This webinar will provide valuable assistance and guidance to medical device firms that are either going through or preparing to go through a recall and want to understand the strategy and expectations of a recall and FDA's involvement.

Recall means the correction or removal of a device for human use where FDA finds that there is a reasonable probability that the device would cause serious, adverse health consequences or death. It is an action taken to address a problem with a medical device that violates FDA regulations. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health. Medical device recalls does not always mean that you must stop using the products or return them to the company.

Why Should You Attend

A recall sometimes means that the medical device needs to be checked, adjusted, or fixed. If an implanted device (for example, a pacemaker or an artificial hip) is recalled, it does not always have to be removed. When an implanted device has the potential to fail unexpectedly, companies often tell doctors to contact their patients to discuss the risk of removing the device compared to the risk of leaving it in place. FDA devices recalls falls into three categories, representing the potential risk to public health: Class I, II, and III.

Areas Covered in this Webinar

• Create and use a recall operational procedure and what should it contain
• Understand what are effectiveness checks
• What happens in a medical device recall
• Learn why a recall is either a correction or a removal depending on where the action takes place.
• Understand what is required for the recall strategy as expected by FDA

Learning Objectives

• Medical device recall authority and guidance
• Depth of recall and using a viable, sustainable and effective strategy
• Understand why the documentation and paper trail are so critical and termination of a recall

Who Will Benefit

• All levels of Management for all departments and those who desire a better understanding
• QA/QC/Compliance/Regulatory Affairs Personnel
• Marketing & Sales Professionals
• Engineering/Technical Services Professionals
• Consultants 
• Operations and Manufacturing Professionals

Level

Beginner

For registration:  https://www.complianceglobal.us/product/700256 

About Compliance Global Inc

Compliance Global Inc; is a training (webinar) organization based in New Hyde Park, New York, providing world-class compliance trainings and online webinars by leveraging a pool of experienced speakers / consultants in the Pharmaceutical, Bio-Technology, Medical Devices, Clinical Compliance, FDA Compliance, Healthcare, BFSI, Life Science & HR streams for improving the knowledge base of the customers. Our trainings are contemporary, simple and cost-effective with easy access and great delivery experience. Compliance Global is a multifaceted entity, an absolute knowledge repository.

Our varied industry expertise ranges across Life Science (Pharmaceutical, Bio-Technology, Medical Devices, Clinical Compliance, FDA Compliance), Healthcare, HR Compliance, BFSI, Food & Dietary Supplements, Insurance, Accounting & Taxation and other Cross Industry streams.

Email: referrals@complianceglobal.us

Toll Free: +1-844-746-4244

Tel: +1-516-900-5515