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2 Day Medical Device Post-Market Regulations and Challenges Online Course: Complaint Handling, MDR Reporting and Recalls Course (January 26-27, 2023)

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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

About ResearchAndMarkets.com
ResearchAndMarkets.com is the world's leading source for international market research reports and market data. We provide you with the latest data on international and regional markets, key industries, the top companies, new products and the latest trends.

CONTACT: CONTACT: ResearchAndMarkets.com Laura Wood,Senior Press Manager press@researchandmarkets.com For E.S.T Office Hours Call 1-917-300-0470 For U.S./ CAN Toll Free Call 1-800-526-8630 For GMT Office Hours Call +353-1-416-8900