cGMPs for Medical Devices, Including In Vitro Diagnostic Devices 2012 is a webinar that covers topics such as:
- Definitions
- QSRs for medical devices and in vitro diagnostic devices
- Quality system (QS) requirements
- Flexibility of the QSRs
- Audits
- Management responsibility and personnel
- Design history file (DHF)
- Design control: design and development planning, design input, design output, design review, design verification, design validation, design transfer, and design changes
- Quality system procedures
- Device master record (DMR)
cGMPs for Medical Devices, Including In Vitro Diagnostic Devices 2012 brings together:
- Regulatory affairs (associates, specialists, managers, and directors)
- Manufacturing professionals
- Quality assurance, quality control, and quality systems (associates, specialists, engineers, managers, directors and VPs)
- Clinical affairs (associates, specialists, coordinators, managers, directors and VPs)
- Product and development (associates, scientists, managers, directors and VPs)
- Research and development (associates, scientists, managers, directors and VPs)
- Contract manufacturing organization (associates, scientists, managers, directors and VPs)
- Site managers, and consultants
- Senior and executive management (VPs, SVPs, Presidents and CEOs)
- Contract research organization (associates, scientists, managers, directors and VPs)
- Contractors and subcontractors