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Event Details


Uncovering and Managing Successful Post Market Compliance for Medical Devices

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Who should attend?

Regulatory Affairs QA/QC Project Managers Regulatory Professional Risk Managers Complaint Handling Teams CAPA Teams


Why you should attend:

Customer satisfaction plays a significant role in measuring a product's postmarket performance. It is an indicator of how effective the product performance is managed. Both the quality system regulation (QSR) and the International Organization for Standardization (ISO) require procedures and processes to monitor and control your post market problems. The complaint-handling mechanism not only collects feedback from unsatisfied customers, but also provides means for failure investigations and subsequent corrective and preventive actions (CAPA).

Medical Device Reporting (MDR) and recall compliance involve regulatory obligations and proper and timely reporting. Failure to properly report events and take corrective and removal actions can cause costly problems for a manufacturer and can be life threating for consumer.. The number of device companies having their recall classified as a Class 1 (most severe) has surged in the past three years. Additionally, product liability and financial risks are staggering when companies fail to properly report and take action when required. This course will provide an understanding of MDR & recall compliance and the interrelationship of Complaint Handling, CAPA, and Risk Management processes. It will be beneficial to all device manufacturers and is recommended for any individuals or teams that are involved in medical device reporting (MDR) and correction & removal processes, including recalls. Over 80% of FDA Inspections target observations for lack of compliance in these areas.

Join Rita Hoffman, RAC an expert in the field of Post-Market Compliance. Not only will you learn from her over her 40 years in both FDA as a Compliance Officer and Ombudsman, learning from her stories of what not to do, but you will take back a desktop manual on Post-Market reference guide.

Areas Covered in the Session:

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

Firms MDR reporting and FDA's handling of MDR 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

Walk-through of case examples

Step-By-Step guide to designing Standard Operating Systems for communicating process for firm's success

Discussion of FDA's New Guidance's on Risk and how it interacts with Recalls

Who will benefit:

Regulatory Affairs


Project Managers

Regulatory Professional

Risk Managers

Complaint Handling Teams

CAPA Teams


Price: $1,295.00 (Seminar Fee for One Delegate) Register for 5 attendees Price: $3,885.00 $6,475.00 You Save: $2,590.00 (40%)* Register for 10 attendees Price: $7,122.00 $12,950.00 You Save: $5,828.00 (45%)* Register now and save $200. (Early Bird)


John Robinson

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