Effective Complaint Handling, Medical Device Reporting and Recalls

Description:
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 analysed, 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, labelling, 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.



Who Will Benefit:
1. Regulatory Affairs Management
2. Regulatory Affairs Specialist
3. Auditors
4. Compliance Officer
5. Compliance Specialist
6. Clinical Affairs
7. Quality Assurance Management
8. Marketing & Sales
9. Distributors/Authorized Representatives
10. Legal Counsel
11. Engineering/Technical Services
12. Operations/Manufacturing
13. Consultants
Areas Covered in the seminar:
1. Reporting complaints
2. Managers
3. Complaint evaluation and investigation
4. Data collection and trending
5. CAPA process for investigating complaints
6. Accelerate complaints recording, investigation, reporting, escalation/triggers and closure cycle as cases are automatically routed from one stage to the next
7. Gain enterprise-wide visibility into the complaints data and track the process with performance metrics, dashboards or other indicators
8. Improve communication and teamwork on complaints across departments and functional areas
9. Drive continuous improvement by tying corrective actions with complaints for a closed loop quality process
10. Improve management of the complaint lifecycle with real-time trending and escalation of customer complaints
11. Understand the History of MDR Regulation
12. What types of Reports does the FDA receive and who must submit Mandatory Reports to the FDA?
13. Who can submit Voluntary Reports to the FDA?
14. How Does the FDA Use Medical Device Reports?
15. What are the exemptions, variances, or alternative forms of adverse event reporting requirements?
16. Basics of a Recall: Initiation, Classification and Public Warning
17. Medical Device Recall Reporting
18. Recall Responsibilities & Requirements
19. FDA's Role
20. Introduction to Medical Device Recalls: Industry Responsibilities
21. Recall Communication and Strategy
22. Monitoring and Auditing Recall Effectiveness
23. Recall Termination
24. Guidance for Industry, Trends and FDA Inspection & Enforcement Statistics and Trends

Speaker Profile:

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.

Location: Phoenix AZ
Date: 27th & 28th, February 2014
Time: 9 AM to 6 PM
Venue: Hilton Garden Inn Phoenix Midtown
Address: 4000 N. Central Avenue, Phoenix, Arizona, 85012, USA

Price: $1295.00 (For One Delegate)
Register now and save $200. (Early Bird)
Until March 20, Early Bird Price: $1,295.00
From March 21 to May 06, Regular Price: $1,495.00

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