2017 - Webinar on Design Verification, Validation and Testing for Medical Devices

Understand proposed changes being worked on by the ISO technical committee for updating the ISO 13485. Awareness of the current requirements and proposed changes will facilitate your preparing in advance and navigating your way through the harmonized international arena to expand your product marketing strategies.
You will gain a thorough insight into the specific auditing requirements of the International ISO 13485 Standard requirements for medical devices. This class will truly build your knowledge from the fundamental principles and help you grow into fulfilling the regulatory requirements as a product developer, manufacturer, auditee for external FDA type of audits and serve as an internal or supplier auditor.
The webinar will also focus on the major difference in expectations between FDA Quality System Regulations and Quality System inspection Techniques (QSR and QSIT) and ISO 13485 for globally distributed products. Latest changes to ISO 13485 for additional vigilance in areas such as supplier management, risk management and training will be discussed.
Areas Covered in the Session :
Requirements of ISO 13485
How to carefully attend to every aspect of the related biomedical standards
Document control
Purchasing Controls
Production controls
CAPA
Identification and Traceability
Changes to ISO 13485
How ISO 13485 differ from FDA QSR 21 CFR 820 requirements
Regulatory expectations of other major growing geographies in the world
Who Will Benefit:
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
Internal Auditors
Quality Auditors
Supplier Auditors
Operations
Manufacturing
Suppliers to medical device industry