Complaint-Handling, MDR and Recall Management - In-person Seminar

Event Details

Time: April 23, 2015 at 9am to April 24, 2015 at 6pm
Location: Hilton Zurich Airport
Street: Hohenbuhlstrasse 10, 8152 Opfikon-Glattbrugg, Switzerland
City/Town: Zurich
Website or Map: https://www.globalcompliancep…
Phone: 18004479407
Event Type: food, fda, medical, device, defence, and, navy, aerospace, mining
Organized By: GlobalCOmpliancePanel
Latest Activity: Feb 19, 2015

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Event Description

Overview:

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.

Who Will Benefit:

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

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

Areas Covered in the seminar:

Reporting complaints
Managers
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

Speaker

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.

Price: $1,595.00

Quick Contact:

NetZealous BDA as GlobalCompliancePanel

USA Phone:1-800-447-9407
Fax: 302-288-6884
support@globalcompliancepanel.com
http://www.globalcompliancepanel.com