2-Day Seminar: Effective Compliance Strategies for Complaint Handling, Medical Device Reporting and Recalls (Philidelphia, PA, United States - March 28-29, 2019) - ResearchAndMarkets.com

The "2 Days Seminar : Effective Compliance Strategies for Complaint Handling, Medical Device Reporting and Recalls" training has been added to ResearchAndMarkets.com's offering.

Description

• 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 your 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

Agenda

DAY 1 SCHEDULE - 8:30 AM - 4:30 PM

Lecture 1:

Complaint Handling

• 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
• 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

Lecture 2:

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

Lecture 3:

Exercise and Recap of Day 1

• Exercise on Product Complaints/Complaint Handling
• Quiz

DAY 2 SCHEDULE - 08:30 AM to 04:30 PM

Lecture 1:

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

Lecture 2:

Recalls

• 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

Lecture 3:

Exercise and Recap of Day 2

• Exercise - MDR and Recall
• Quiz

For more information about this training visit https://www.researchandmarkets.com/research/rkw3cq/2day_seminar?w=4

View source version on businesswire.com: https://www.businesswire.com/news/home/20190218005166/en/