Discounted tickets are available now!
New York Professional Events List
Complaint-Handling, MDR and Recall Management
Link to Website
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.
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
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
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 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
Exercise and Recap of Day 2
- Exercise - MDR and Recall
David R. DillsRegulatory Affairs & Compliance Consultant,
David R. Dills Regulatory Affairs & Compliance Consultant currently provides regulatory affairs, compliance and quality consultative services for early-stage and established Class I/II/III device, In Vitro Diagnostics, and bio/pharmaceutical manufacturers on the global landscape, and also has an accomplished record with more than 25 years of experience in the areas of Regulatory Affairs, Compliance and Quality Systems. He has been previously employed, with increasing responsibilities by medical device manufacturers and consultancies, including a globally recognized CRO and has worked directly with manufacturers engaged in compliance remediation activities and services involving consent decrees, CIA's, warning letters, 483 observations, and customer generated compliance events, and prepares for and conducts QS and regulatory audits.
He has been directly involved with constructing, reviewing, and/or remediating regulatory submissions, including 510(k), PMA, IDE applications, BLA and NDA submissions, preparing Supplements, Amendments, U.S. Agent for clients, works closely with the key stakeholders and Agency/Center Reviewers regarding submission meetings and negotiations; clinical affairs and study submissions; and provides regulatory submissions and post-market project leadership and guidance covering different therapeutic and medical specialties based on classification.
Mr. Dills has a strong background in the interpretation and applicability of FDA regulations, including 21 CFR 210/211, 21 CFR 820, GMP Quality System implementation and compliance requirements, conducts customized GxP training, leads and directs activities for the registration and approval process and working with Agencies in the Pacific Rim, EU and The Americas, including but not limited to FDA, European Medicines Agency-EMA, MHRH, ANVISA, PMDA, TGA, and Health Canada; and defining and executing regulatory compliance, risk mitigation and remediation strategies in response to inspection findings. Additional activities include Pre-FDA Facility Inspections, Mock Audits/Due diligence and assessing state of readiness for Pre-approval inspection (PAI/PMA), proof of management oversight, facilitate and direct efforts for remediation planning and monitoring, and assessment of the critical sub-systems, records and document controls
He provides PM support and consultative services on behalf of manufacturers and subcontracted by third-party consultancies and provides services involving all phases of the product development, submission, and commercialization process from premarketing to postmarketing; conducting supplier and QS audits/assessments; establishment registration and listing; Agency inspection readiness preparation and remediation; preparing Agency responses due to enforcement actions; conducting GxP audits and preparing CAP/remediation plans; compliance engineering support; support and/or lead efforts regarding Adverse Event, MDR, Incident Reporting, Postmarketing 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.
Mr. Dills manages quality, regulatory and compliance projects with multiple competing priorities having a direct impact on site operations/commercial opportunities. Develops strategies for governmental approval to introduce new products to market, provides guidance and clarity on regulatory requirements, prepares and/or reviews submissions [e.g., NDA, ANDA, e-CTD, 510(k), PMA, IDE and BLA], including design dossiers and technical files, and other applications for the Pacific Rim, The Americas and EU. Directs and leads efforts in establishing and retooling QA systems with emphasis on preventing the design, manufacture, and shipment of defective products.
Mr. Dills manages regulatory problems (e.g. AE's, MDRs, Agency enforcement, and complaints) 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. Background encompasses broad capabilities in quality systems; documentation development and remediation; RA/RC oversight and governance; design controls; CAPA/investigations; GxP training; software and process validation with compliance oversight; supplier management; interfaces with FDA and other Agencies on the regulatory landscape; compliance with MDD/IVDD Directives and Technical File/Design Dossier and CE Mark requirements; and demonstrates credible experience to optimize business performance through proactive strategies to mitigate compliance exposure.
He also develops strategies and adds business value to manufacturers by providing strategic and tactical solutions that facilitate the achievement of regulatory and quality milestones and on minimizing delays due to noncompliance. He conducts Compliance Governance Assessments and Agency Mock Inspections; provides assistance during inspections and with post-inspection correspondence and meetings, involved in the product life cycle and commercialization process and works effectively across all functions for overall corporate compliance to support a company's goals and strategies.
Mr. Dills analyzes the benefits/risks for informed decision-making; interprets the regulatory precedents and new legislation; understands the competitive landscape; develops the business and regulatory approach; conducts persuasive communication with authorities (FDA, PMDA, EMA/MHRA, TGA, MOH, ANVISA, CFDA and other Agencies); executes an effective path to approval; assists with GxP compliance strategies, effectively coordinates development in multiple markets; selects appropriate testing and manufacturing suppliers; and strives for overall corporate compliance with regulations in The Americas, EU, and Pacific Rim.
He provides direction on understanding the regulatory landscape for the product and provides a fully integrated approach to device development including design controls, and effective communications with Regulatory Authorities related to product development and post-marketing activities.
Mr. Dills has served on the Faculty Advisory Board for the Pharmaceutical Training Institute, Editorial Advisory Boards for Software Quality Professional and the Institute of Validation Technology (IVT), publisher of the Journal of GXP Compliance and Journal of Validation Technology and on the Readers' Board for Medical Device & Diagnostic Industry and Medical Product Manufacturing News and was nominated and accepted for inclusion into the 2005-2006 Strathmore's Who's Who of Professionals.
Mr. Dills has authored and published validation, regulatory and compliance-related articles, commentaries and technical guides, and is an accomplished global industry presenter. Mr. Dills' academic degrees include Environmental Science and Biology. He is a former Chair and Co- Chair of ASQ's Section 1506 and associated with the Biomedical Division, RAPS, AdvaMed, PDA, ISPE, and other industry working groups.
VIP Life Time Subscription to our Newsletters!