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:
- Different ways to overcome one of the major hindrances device manufacturers encounters
- How the FDA expects you to grow and device proper handling of complaints reportable or non-reportable, product complaint management and certification
- How and when to file Medical Device Reports (MDR), actual and suitable message with the apt controlling agencies in the event of a recall.
- 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:
- Creating Standard Operating Systems (SOPs) for Post-Market Quality Systems and
- What to expect from the changes in ORA with Inspection Structure Realignment
- 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
- Knowledge of ways to comply with complex Complaint Handling, MDR, and Recall requirements
- Companies' MDR reporting and FDA's management of reports
- Company training in the event of a Recall, recall policy, notification letter, and interactive with the FDA
- Diminish the risk of controlling implementation activities
- Contribution to the creation and maintenance of real events for treatment complaints, reportable events, and recalls
- Comprehend the relationship and interaction with other quality system elements as they relate to complaints and reportable events
- Walk-through of case instances
- A step-by-step guide to designing Standard Operating Systems for communicating processes for the success of the firm
- Discussion of FDA's New Guidance on Risk and how it interacts with Recalls
Who Should Attend:
- CAPA Teams
- Quality Assurance
- Regulatory Affairs
- Risk Management Professionals
- Quality Control
- Project Managers
- Regulatory Professional
- Complaint Handling Teams
Key Topics Covered:
Session 1
- Grievance Management and FDA Prospects (90 mins)
Break (15 mins)
Session 2
- Continuance Grievance Treatment and FDA Expectations (30 mins)
- Medical Device Reporting Procedures (MDR) Regulations, Procedures, and Malfunctions (60 min)
Lunch Break (45 mins)
Session 3
- Continuation of Medical Device Reporting Events (MDR) Rules, Measures, and Malfunctions (60 min)
- MDR reporting by the firm, agents Voluntary Malfunction Summary Reporting (VMSR), and eMDR Discussion (30 min)
Break (15 mins)
Session 4
- Guidance Documents Update (30mins)
- Being Recall Ready (30mins)
Questions and Recap (10 mins)
Session 5
- Recalls, Definition, and Legal Authority Overview (60 mins)
- Corrective and Preventative Actions (CAPA) (30 mins)
Break (15 mins)
Session 6
- Health Hazard Evaluations HHE/HRA (30 mins)
- Elements of a Correction and Removal - 806 Reporting (45 mins)
Lunch Break (45 mins)
Session 7
- Developing Effective Strategies / Communicating and Negotiating with FDA (45mins)
- Notifications Letters and Press Releases (20 mins)
- Silent Recalls / Product Enhancements and Enforcement Actions (20 mins)
Break (10 mins)
Session 8
- Product Retrieval (20 mins)
- Status Reports (20 mins)
- Effectiveness Checks Follow-up Planning (20 mins)
- Terminating a Recall (15 mins)
- Wrap-up (5 mins)
For more information about this training visit https://www.researchandmarkets.com/r/prdi74
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