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Healthcare Training 2020 - Effective Complaint Handling, Medical Device Reporting and Recalls

Date2020-03-19 - 2020-03-20


VenueBaltimore MD, USA - United States USA - United States

KeywordsFDA Compliance; Healthcare; Pharmaceutical


Topics/Call fo Papers

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 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 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
Areas Covered in the seminar:
Reporting complaints
Complaint evaluation and investigation
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 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
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 Trends
Who Will Benefit:
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
Event link:
Contact Info:
Netzealous LLC - Globalcompliancepanel
Phone No: 1-800-447-9407
Fax: 302 288 6884

Last modified: 2019-12-06 22:08:28