ISO 13485:2016 – Proposed Changes to the International Medical Device Standard
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ISO 13485:2016 – Are you prepared to understand and implement the changes being finalized by the ISO technical committee for the long awaited update to the medical device standard ISO 13485:2003?. Awareness of the upcoming key requirements and proposed changes will facilitate your preparing in advance for navigating your way through the newly harmonized international standard arena to:
- Lay a strong foundation for your regulatory compliance
- Expand your product marketing strategies by staying ahead of the game.
You will gain a thorough insight into the specific auditing requirements of the International new ISO 13485 Standard requirements for medical devices. This webinar will truly build your knowledge from the fundamental principles and help you grow into fulfilling your quality system requirements as a product developer, manufacturer, auditee for notified body and global customer audits and as an internal or supplier auditor.
The webinar will also focus on the major difference in expectations for additional vigilance in areas such as supplier management, risk management and resource management.
Areas Covered in the Session :
- You will gain a thorough understanding of:
- Requirements of New and Improved ISO 13485:2016
- How to carefully implement every aspect of this biomedical standard
- Key Requirements for Quality Management System (QMS)
- Leadership and Commitment and Implementation Strategy
- Quality Resource Management
- CAPA and how Preventive Action(PA) is being replaced by ” Risk Management”
- Changes to ISO 13485:2015 from ISO 9001:2015
- How ISO 13485 differs from FDA QSR 21 CFR 820 requirements
- Regulatory expectations of other major growing geographies in the world and how they will adopt this important standard
Who Should Attend:
A must attend webinar for Managers, Supervisors, Leads, Specialists, Engineers and Groups in Department of:
- Quality Assurance
- Regulatory Affairs
- Research & Development
- Quality Control
- Supplier Management
- Documentation
- Production
- Operations
- Manufacturing
- Suppliers to medical device industry
- As well as, Internal, Quality and/or Supplier Auditors
Course Director: MEENA CHETTIAR
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