Boston Professional Events List

Effective Compliance Strategies for Complaint Handling, Medical Device Reporting and Recalls

Mar 30, 2021 - 08:30 AM - Mar 31, 08:30 AM
DoubleTree by Hilton Philadelphia Airport
DoubleTree by Hilton Philadelphia Airport4509 Island AvePhiladelphia, PA 19153United States,

PA ,
ZIP: 19153
Phone: 844-267-7299 | 954-947-5671


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 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 should you 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 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


Session Highlights

• 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

Who will Benefit

This seminar will provide an overview and in-depth snapshot of the process for managing your product complaint/complaint handling program, Medical Device Reporting program and addressing and facilitating Recalls. Employees who will benefit include all levels of management and departmental representatives from key functional areas and those who desire a better understanding or a "refresh" overview of the complaint handling, MDR and recall process from start to finish, including:

• Regulatory Affairs Management
• Regulatory Affairs Specialist
• Auditors
• Compliance Officer
• Compliance Specialist
• Clinical Affairs
• Quality Assurance Management
• Marketing & Sales 
• Distributors/Authorized Representatives
• Legal Counsel
• Engineering/Technical Services
• Operations/Manufacturing
• Consultants


Day 1 Schedule

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 in to 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

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:


  • 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 FDA of a product problem?

  • Who should be involved in the decision process?

  • Who should be responsible for communicating with 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 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 are 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

Speaker Details

About the Speaker

David R. Dills, is currently the Director of Regulatory Services at CROMSOURCE, an international contract research organization (CRO to the pharmaceutical, biotechnology, and medical device industries. 

Wcs Seminars
Registration Details
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Event Categories
Keywords: pharmaceutical


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