Effective Complaint Handling, Medical Device Reporting and Recalls and Avoiding Costly Errors 2014 is a conference that covers topics such as:
- 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
Effective Complaint Handling, Medical Device Reporting and Recalls and Avoiding Costly Errors 2014 brings together:
- 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