The "Effective Complaint Handling, Medical Device Reporting and Recalls" conference 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.
The results of this evaluation should lead to a conclusion regarding whether the complaint was valid, what the root cause of the complaint was, and what action is necessary to prevent further occurrences. Complaints cannot be ignored. They are an excellent indicator of problems with the use, design, and/or manufacture of a product. A single complaint that is thoroughly investigated may lead a company to take remedial or corrective action. It may also take an ongoing analysis of numerous complaints before a trend is spotted that causes a company to initiate changes in their product, labeling, packaging or distribution. The regulatory expectations for both pharmaceuticals and medical devices will be emphasized as well as an overview of best practices for timely and effective investigations. Trending is the only way a company can stay on top of emerging quality issues and address those that are most pressing.
Why you should attend:
- Understand that although 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 to 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
Day 1 Schedule
- What are the elements of an effective complaint management system?
- How does risk management influence complaint handling decisions?
- What are the responsibilities of other departments?
- What is the best way to train customer contact employees?
- What steps would the FDA expect to see the departments taking that sorts out potential MDRs, product complaints, and other reportable events?
- What and how do you perform trending?
- What are examples of how companies trend and analyze service calls and product complaints?
- Understand how and why CAPA is tied into product complaint investigation
- What is an appropriate complaint handling system in a risk-based post-market environment?
- How do you audit a complaint handling system?
- From your audits, how do you judge that your complaint handling system is effective?
- Assignment of responsibility
- The manufacturer should develop a method for maintaining records of complaints and investigations that: is functional and economical, meets company needs, and meets FDA requirements and expectations
- Identify designated complaint handling unit
- Instructions for documenting complaint information
- Process for evaluating complaints
- Process for investigating complaints
- Identify and process MDR's
- How to process customer returns
- Records and trend analysis
- Complaint closure
- Examples of tools currently being used to conduct investigations
- How far and in-depth do you go with your investigations
- What are current FDA 'hot' buttons and trends, benchmarks and best practices for investigations
- How to become a 'good' investigator and the emphasis on closed-loop investigations
- Written Procedures: Designated Complaint Handling Unit, Training and Records
- Recent Enforcement Actions
Medical Device Reporting
- Introduction to Medical Device Reporting
- What are the key terms, definitions and forms?
- MDR procedures and processes
- What are the requirements for developing, maintaining, and implementing written MDR procedures that apply to me?
- How do you manage international reporting requirements under your complaint handling system?
- Consider the relationship between MDRs and Risk Assessments
Exercise and Recap of Day 1
- Exercise on Product Complaints/Complaint Handling
Day 2 Schedule
Medical Device Reporting
- eMDR Electronic Medical Device Reporting
- How to Report a Problem
- Event Problem Codes and Manufacturer Evaluation Codes
- MedWatch: Safety Information and AER Program
- Completing Form FDA 3500A
- What form should I use to submit reports of individual adverse events and where do I obtain these forms?
- Where and how do I submit reports and additional information?
- Does the information in my report constitute an admission that the device caused or contributed to the reportable event?
- What are the requirements for developing, maintaining, and implementing written MDR procedures and maintain records/files that apply to me?
- Requirements for Individual Adverse Event Reports
- User Facility Reporting, Importer Reporting, and Manufacturer Reporting Requirements
- What happens in a medical device recall: Firm-initiated recall vs. mandatory recall
- What information needs to be reported?
- What types of records do companies need to keep?
- Prior to notifying FDA, what steps should you have taken?
- What are the dos and don'ts when informing the FDA of a product problem?
- Who should be involved in the decision process?
- Who should be responsible for communicating with the FDA?
- What are the consequences of a recall?
- What factors should you consider when determining whether or not to get your product back?
- How do you prepare for a post recall inspection?
- What customer and other outside communications are necessary?
- What documentation should be prepared?
- How should the product liability implications of recall communications be handled?
- What is an effectiveness check?
- Health Hazard Evaluations are conducted by the FDA
- How should you write your recall correspondence?
- How do you determine that your recall is completed and what do you do to close your recall internally and with FDA?
- Create and use a recall operational
- Understand what is required for the recall strategy as expected by FDA
- Depth of recall and using a viable, sustainable and effective strategy
- Understand why the documentation and paper trail is so critical and termination of a recall
- Discuss most recent recalls not only for devices but pharmaceuticals and why the numbers are alarming
Exercise and Recap of Day 2
- Exercise - MDR and Recall
For more information about this conference visit https://www.researchandmarkets.com/r/5fvz32
Laura Wood, Senior Press Manager
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