Upcoming Events at DoubleTree by Hilton Philadelphia Airport
Thu Oct 25, 9:00 AM - Fri Oct 26, 6:00 PM
DoubleTree by Hilton Philadelphia Airport
4509 Island Avenue, Philadelphia, PA 19153, Philadelphia, PA 19153
Community: Upper West Side
Description
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.
Event Details
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 mainten
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 mainten
