A thorough understanding of MDR & recall compliance is what this course on medical device complaint handling training strives to provide. It also addresses how the CAPA, risk administration, and complaint management processes interact.
Grievance handling, MDRs, and recalls are ostentatious, time-consuming, and frequently result in harsher financial penalties. More than 80% of FDA inspection observations focus on these areas of noncompliance.
Learning Objectives for Medical Device Reporting Understanding of how to adhere to complicated complaint handling, MDR, and recall requirements.
MDR reporting by businesses and report management by FDA
Company recall training, a recall policy, a notice letter, and interaction with the FDA
Reduce the danger of monitoring implementation activities
Participation in the establishment and upkeep of actual events for treatment complaints, reportable incidents, and recalls
Recognize how other quality system components relate to and interact with complaints and other reportable occurrences.
Case examples are described in detail
A step-by-step manual for creating Standard Operating Systems that communicate processes for the benefit of the company
A discussion of the FDA's new risk guidance and how recalls are related to it
Background Information for Medical Device Complaint Handling Training
Medical Device Reporting (MDR) and consenting to recall, pose a threat to the continued existence of all device manufacturers. The FDA is continuing its efforts to regularly issue FDA Warning Letters and serious implementation actions, including criminal and civil penalties imposed on companies that failed to properly disclose occurrences and take the appropriate corrective and removal measures. In the previous three years, there has been an increase in the number of device manufacturers whose recall has been given the Class 1 (most serious) label in the USA. When businesses don't properly report and act when necessary, they run huge financial and product liability risks.
Medical device reporting teams and people are not required to use it, but it will benefit all device manufacturers (MDR) and computerized system validation training.
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Who could gain from taking this Medical Device Reporting Training course?
Anyone in the medical device sector who oversees operations including product complaints, recalls, and medical device reporting will clearly benefit from taking this course.
Teams from CAPA
Quality Control
The Department of Regulatory Affairs
Professionals in Risk Management
Quality Assurance
In charge of projects
Professional in Regulatory Affairs
Teams for Handling Complaints
So, be a part of the WCS seminar to get benefited from the top-class consultants.
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