Dublin, Dec. 30, 2022 (GLOBE NEWSWIRE) -- The "A Comprehensive View of Medical Device Post-Market Regulations and Challenges -Complaint Handling, MDR Reporting and Recalls Course" training has been added to ResearchAndMarkets.com's offering.
This course on Medical Device Complaint Handling Training aims at providing a close understanding of MDR & recall compliance. It also deals in handling the interrelationship of Complaint Handling, CAPA, and Risk Administration procedures.
Post-Market activities, Grievance Handling, MDRs, and Recalls are luxurious, time-consuming, and often lead to graver monetary penalties. Over 80% of FDA Inspection target observations for lack of compliance in these areas.
By attending this seminar, every trainee will be able to find out and discover:
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Different ways to overcome one of the major hindrances device manufacturers encounters
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How the FDA expects you to grow and device proper handling of complaints reportable or non-reportable, product complaint management and certification
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How and when to file Medical Device Reports (MDR), actual and suitable message with the apt controlling agencies in the event of a recall.
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How to demeanor improvement and elimination actions to avoid a recall emergency, including required recordkeeping, anticipation from FDA and other monitoring agencies in the event of a recall, and crucial factors in applying and upholding compliance with the regulations and real-life experiences of FDA.
New course materials have been added, and updated content now contains:
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Creating Standard Operating Systems (SOPs) for Post-Market Quality Systems and
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What to expect from the changes in ORA with Inspection Structure Realignment
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This Seminar on Medical Device Reporting Training will have you stop spinning your wheels with supplementary actions, and leave you with a complete knowledge set that only WCS can provide.Who are the possible beneficiaries of this course in Medical Device Reporting Training?
Objectives of Learning- Medical Device Reporting Training
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Knowledge of ways to comply with complex Complaint Handling, MDR, and Recall requirements
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Companies' MDR reporting and FDA's management of reports
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Company training in the event of a Recall, recall policy, notification letter, and interactive with the FDA
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Diminish the risk of controlling implementation activities
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Contribution to the creation and maintenance of real events for treatment complaints, reportable events, and recalls
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Comprehend the relationship and interaction with other quality system elements as they relate to complaints and reportable events
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Walk-through of case instances
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A step-by-step guide to designing Standard Operating Systems for communicating processes for the success of the firm
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Discussion of FDA's New Guidance on Risk and how it interacts with Recalls