Each attendee will receive 2-Day workshop materials by the speaker. Seminar Also Includes Certificate, Complimentary Breakfast, Lunch & High Tea/Coffee.
Complaint handling systems have come under intense scrutiny by the FDA in recent years and enforcement trends confirm this as of recent. The seminar will examine the current industry and FDA environment and provide you with the knowledge and tools for survival as well as making existing complaint handling systems more robust, easier to manage and enforce. It will provide a step-by-step guide for establishing, deploying, managing and auditing your Complaint Handling System for today's medical device industry environment.
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 on-going 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.
Medical Device Reporting (MDR) is the mechanism for FDA to receive significant medical device adverse events from manufacturers, importers and user facilities, so they can be detected and corrected quickly. Manufacturers, User Facilities, and Importers are required to submit certain adverse events to FDA. Health professionals and consumers may submit reports of device adverse events or product problems to FDA via the MedWatch program in one of several ways. This seminar will provide the snapshot of the of the MDR regulation, why you have to report, how and where to report, introduce you to the forms and provide step-by-step instructions as to your responsibilities.
Medical device recalls are usually conducted voluntarily by the manufacturer. In rare instances, where the manufacturer or importer fails to voluntarily recall a device that is a risk to health, FDA may issue a recall order to the manufacturer and the seminar will describe the procedures the FDA will follow in exercising its medical device recall authority, as well as introduce the audience to the recall classification process, recall strategy, recall status reports, termination of a recall, effectiveness checks, company’s recall procedure, among other key areas.
Why should you attend (Course Objective)?
- 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
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.
Medical Device Reporting (MDR) is the mechanism for FDA to receive significant medical device adverse events from manufacturers, importers and user facilities, so they can be detected and corrected quickly. User Facilities (e.g., hospitals, nursing homes) are required to report suspected medical device related deaths to both the FDA and the manufacturers. User facilities report medical device related serious injuries only to the manufacturer. If the medical device manufacturer is unknown, the serious injury is reported by the facility to FDA. Health professionals within a user-facility should familiarize themselves with their institution procedures for reporting adverse events to the FDA.
The MDR process impacts device user facilities, manufacturers, importers, and distributors. If you are a device user facility, you must report deaths and serious injuries that a device has or may have caused or contributed to, establish and maintain adverse event files, and submit summary annual reports. If you are a manufacturer or importer, you must report deaths and serious injuries that your device has or may have caused or contributed to, you must report certain device malfunctions, and you must establish and maintain adverse event files. If you are a manufacturer, you must also submit specified follow-up.
Recall means the correction or removal of a device for human use where FDA finds that there is a reasonable probability that the device would cause serious, adverse health consequences or death. It is an action taken to address a problem with a medical device that violates FDA law. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.
A medical device recall does not always mean that you must stop using the product or return it to the company. A recall sometimes means that the medical device needs to be checked, adjusted, or fixed. If an implanted device (for example, a pacemaker or an artificial hip) is recalled, it does not always have to be removed. When an implanted device has the potential to fail unexpectedly, companies often tell doctors to contact their patients to discuss the risk of removing the device compared to the risk of leaving it in place. FDA classifies medical device recalls into three categories, representing the potential risk to public health: Class I, II, and III.
- 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
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 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
- 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
- Meeting reporting requirements for FDA
- Recent enforcement actions
Exercise and Recap of Day 1:
- Exercise on Product Complaints/Complaint Handling
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
- Recent enforcement actions
- 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 and why effectiveness verification checks are important
- 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
- Latest FDA statistics and trends with recent recalls
Exercise and Recap of Day 2:
- Exercise - Complaint Investigation, MDR and Recall
- Recap of topics and key discussion points and take away message
- FAQs and latest trends
David R. Dills,
Regulatory Affairs & Compliance Consultant,
David R. Dills
David R. Dills, Regulatory & Compliance Consultant with more than 24 years of hands-on experience and a proven track record within the FDA regulated industry, has an extensive regulatory and compliance background with Class I/II/III and IVD devices, pharmaceutical operations, and manages activities within the global regulatory and compliance space.
He manages quality, regulatory and compliance projects with multiple competing priorities having a direct impact on site operations and commercial opportunities and develops strategies for governmental approval to introduce new products to market, provides guidance on regulatory and compliance requirements and prepares/reviews worldwide submissions/dossiers/technical files and addresses global regulatory requirements.
Background encompasses broad capabilities in quality systems, validation, regulatory affairs, compliance, auditing, interfacing with the regulatory agencies, addressing enforcement actions and mitigating compliance exposure for companies via remediation, compliance engineering support, post-marketing surveillance and vigilance reporting; clinical affairs, establish and/or remediate Quality Management and documentation systems for GxP compliance; preparation for ISO 13485 registration and CE Mark; and multi-country product registrations and licensing; and working with Notified Bodies, and AR's. David manages regulatory problems (e.g. AE's, MDRs, Agency enforcement, complaints/investigations, field alerts/recalls) related to development, manufacturing, and commercialization, and recommends action to senior leadership to ensure effective resolution for manufacturers to achieve sustainable and proven compliant systems.
This is based on analyzing the benefits/risks for informed decision-making and interprets the regulatory precedents and new legislation. He strives to optimize business performance through proactive strategies to mitigate compliance exposure by providing strategic and tactical solutions that facilitate the achievement of regulatory and quality milestones. David has been previously affiliated with well-known device manufacturers and service providers, including a global CRO and has served in various quality, regulatory and compliance management and advisory capacities with increasing responsibilities. David is an industry speaker and author of technical and compliance related topics published in industry journals. Please refer to his profile provided herein for additional information about his background and areas of interest and focus.
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
- Compliance Officer
- Compliance Specialist
- Clinical Affairs
- Quality Assurance Management
- Marketing & Sales
- Distributors/Authorized Representatives
- Legal Counsel
- Engineering/Technical Services
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