DUBLIN--(BUSINESS WIRE)--The "Effective Compliance Strategies for Complaint Handling, Medical Device Reporting and Recalls" training has been added to ResearchAndMarkets.com's offering.
An effective complaint handling system is an extremely important part of any quality system. Manufacturers should understand that any complaint received on a product shall be evaluated and, if necessary, thoroughly investigated and analyzed, and corrective action shall be taken.
Why should you attend? The following are covered:
Understand that although the FDA does not specify a standard complaint handling system, the requirements do specify certain actions that shall be included in any system.
Grasp and comprehend the definitions and elements of the regulatory requirements for Complaint Handling, Medical Device Reporting and handling of Recalls.
All personnel who deal with customers, or who may receive a complaint call, must be trained in the proper routing/handling of complaints.
Provide information about FDA's Medical Device Reporting (MDR) regulation and the Voluntary Reporting program called MedWatch.
Introduce you Medical Device Reporting and to help you better understand the process and benefits of Voluntary Reporting and responsibilities.
Latest Amendments to the MDR Regulation to Implement FDAMA Changes.
To Recall or Not to Recall: Issues to consider regarding whether a Field Action is required.
Determine when a recall is required and how to manage a recall, who must report, when to report, what to report, where to report, recordkeeping requirements, FDA regulatory authority, references and guidance.
Seminar attendees are encouraged to bring examples of their work from the functional area on the various topics as applicable for group discussion.
Review and discuss pain points, challenges and solutions.
- Reporting complaints
- Complaint evaluation and investigation and effective root cause analysis
- Data collection and trending
- CAPA process for investigating complaints
- Accelerate complaints recording, investigation, reporting, escalation/triggers and closure cycle as cases are automatically routed from one stage to the next
- Gain enterprise-wide visibility into the complaints data and track the process with performance metrics, dashboards or other indicators
- Improve communication and teamwork on complaints across departments and functional areas
- Drive continuous improvement by tying corrective actions with complaints for a closed loop quality process
- Improve management of the complaint lifecycle with real-time trending and escalation of customer complaints
- Understand the History of MDR Regulation
- What types of Reports does the FDA receive and who must submit Mandatory Reports to the FDA?
- Who can submit Voluntary Reports to the FDA?
- How to submit e-MDR reports and ensure timely reporting requirements are met for MedWatch 3500A
- How Does the FDA Use Medical Device Reports?
- What are the exemptions, variances, or alternative forms of adverse event reporting requirements?
- Basics of a Recall: Initiation, Classification and Public Warning
- Medical Device Recall Reporting and Classification Levels
- Recall Responsibilities & Requirements
- FDA's Role
- Introduction to Medical Device Recalls: Industry Responsibilities
- Recall Communication and Strategy
- Monitoring and Auditing Recall Effectiveness
- Recall Termination
- Guidance for Industry, Trends and FDA Inspection & Enforcement Statistics and Trend
For more information about this training visit https://www.researchandmarkets.com/research/bnwb45/2_day_course?w=4