Definitions and elements of the regulatory requirements for Complaint Handling, Medical Device Reporting and handling of Recalls
Although FDA does not specify a standard complaint handling system, the requirements do specify certain actions that shall be included in any system
FDA`s Medical Device Reporting (MDR) regulation and the Voluntary Reporting program called MedWatch
All personnel who deal with customers, or who may receive a complaint call, must be trained in the proper routing/handling of complaints
Latest Amendments to the MDR Regulation to Implement FDAMA Changes
Medical Device Reporting and the process and benefits of Voluntary Reporting and responsibilities
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
To Recall or Not to Recall: Issues to consider regarding whether a Field Action is required
Who should Attend
Regulatory Affairs Specialist
Regulatory Affairs Management
Compliance Officer
Auditors
Clinical Affairs
Compliance Specialist
Marketing & Sales
Quality Assurance Management
Legal Counsel
Distributors/Authorized Representatives
Operations/Manufacturing
Engineering/Technical Services
Consultants
Past Events
Effective Complaint Handling, Medical Device Reporting and Recalls and Avoiding Costly Errors 2014 - 25-26 Sep 2014, Hilton Sydney, Australia (46954)
Important
Please, check "Effective Complaint Handling, Medical Device Reporting and Recalls and Avoiding Costly Errors" official website for possible changes, before making any traveling arrangements
