Subscribe NewsletterCurrent Good Manufacturing Practice for Medical Devices Including IVDs
Course "Current Good Manufacturing Practice for Medical Devices Including IVDs" has been pre-approved by RAPS as eligible for up to 1.00 credits towards a participant's RAC recertification upon full completion.
Overview: This webinar is intended to help you get familiar with the current Good Manufacturing Practice (cGMP) for medical devices including in vitro diagnostic medical devices. This webinar is further intended to provide guidance on the cGMP requirements set out in the Quality System Regulations (QSRs), which help assure that medical devices are safe and effective for their intended use.
Understanding quality system regulations and requirements can significantly contribute to achieving compliance fast, resulting in saving significant amount of time and efforts and bringing quality and innovative medical products to the market faster. This webinar will discuss Quality System (QS) regulations, requirements and compliance. At the end of the webinar, you will get familiarized with the current Good Manufacturing Practice (cGMP) for medical devices including in vitro diagnostic medical devices.
At the end of the webinar, you will leave empowered in that you would take or choose to take different approaches when exercising your judgment and discretion.
Why Should You Attend: All medical devices are subject to good manufacturing practices. This webinar is intended to help you get familiar with the current Good Manufacturing Practice (cGMP) for medical devices including in vitro diagnostic medical devices.
Areas Covered in the Session:
- Overview and review of the US QSRs for medical devices
- Flexibility of the QSRs
- Definitions
- Quality system requirements
- Management responsibility
- Audits
- Personnel
- Design control
- validation, design transfer, and design changes
- Design history file (DHF) and device master record (DMR)
- Quality system procedures
- Purchasing controls
- Inspection, measuring and test equipment
- Process validation
- Corrective and preventive action (CAPA)
- Complaint files
- Servicing
- Quality requirements for premarket approval (PMA) application
- Enforcement actions: case studies
- Lessons learned
Who Will Benefit:
- CEOs
- VPs
- Compliance officers
- Attorneys
- Clinical affairs
- Regulatory affairs
- Quality assurance
- R&D
- CROs
- Consultants
- Contractors/subcontractors