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.

During the seminar, Ms. Hoffman will explain proper handling of complaints reportable or non-reportable, product complaint handling and documentation, how and when to file Medical Device Reports (MDR), effective and appropriate communication with the appropriate regulatory agencies in the event of a recall. She will also discuss how to conduct a correction and removal actions to avoid a recall crisis, including required recordkeeping, expectation from FDA and other regulatory agencies in the event of a recall and key factors in implementing and maintaining compliance with the regulations and real life experiences of FDA.

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.
• Assist with the creation and maintenance of effective procedures for handling complaints, reportable events and recalls.
• Understand the relationship and interaction with other quality system elements as they relate to complaints and reportable events.

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
• Complaint Handling Teams
• CAPA Teams