Post-Market Compliance for Medical Devices and Evolving Reporting Requirements: Complaint Handling, MDR/eMDR and Recalls including UDI update

This interactive one and a half day course led by Ms. Rita Hoffman, Former FDA CDRH Recall Branch Chief, who has more than 36 years’ experience with the FDA will provide the participants tools to minimize risk of regulatory enforcement actions.

Learning Objectives:

Understand how to comply with complicated Compliant Handling, MDR and Recall requirements.

Firms MDR 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.

Who will Benefit:

This course will benefit anyone in the medical device industry that handles functions involving product complaints, recalls, medical device reporting.

Regulatory Affairs

QA/QC

Project Managers

Regulatory Professional

Risk Managers

Note:

Use coupon code NB5SQH8N and get 10% off on registration, Valid till Dec 31st 2015.

For Registration:

http://www.complianceonline.com/complaint-handling-medical-device-reporting-and-recalls-seminar-training-80068SEM-prdsm?channel=sciencedz