Effective Complaint Handling, Medical Device Reporting and Recalls and Avoiding Costly Errors 2014

  • 25-26 Sep 2014
  • Hilton Sydney, Australia

Description

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

Past Events

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

Event Categories

Government & Global Issues: Law & Regulations
Health & Medicine: Medical device

Other Events with Similar Categories

Other Events with Similar Location or Organizer

Featured Conferences & Exhibitions