Current Good Manufacturing Practice for Medical Devices Including IVDs 2013

  • 31 Jan 2013
  • Webinar

Description

Current Good Manufacturing Practice for Medical Devices Including IVDs 2013 is a webinar that covers topics such as:

  • Flexibility of the QSRs
  • Overview and review of the US QSRs for medical devices
  • Quality system requirements
  • Definitions
  • Audits
  • Management responsibility
  • Design control
  • Personnel
  • Design history file (DHF) and device master record (DMR)
  • Validation, design transfer, and design changes
  • Purchasing controls
  • Quality system procedures
  • Process validation
  • Inspection, measuring and test equipment
  • Complaint files
  • Corrective and preventive action (CAPA)
  • Quality requirements for premarket approval (PMA) application
  • Servicing
  • Lessons learned
  • Enforcement actions: case studies

Current Good Manufacturing Practice for Medical Devices Including IVDs 2013 brings together VPs, CEOs, Attorneys, Compliance officers, Regulatory affairs, Clinical affairs, R&D, Quality assurance, Consultants, CROs and Contractors/subcontractors.

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Important

Please, check "Current Good Manufacturing Practice for Medical Devices Including IVDs" official website for possible changes, before making any traveling arrangements

Event Categories

Health & Medicine: Healthcare, Medical device

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