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
- Suppliers to medical device industry
- As well as, Internal, Quality and/or Supplier Auditors
Course Director: MEENA CHETTIAR
Meena Chettiar currently works as a Quality and regulatory Manager at ProMed Pharma in Minneapolis. Meena has worked as a Senior Supplier quality engineer at Covidien, Senior Quality Associate (Lead Auditor and CAPA Coordinator) at Baxter Bio Surgery in St. Paul, MN. Meena worked as a Senior Quality Control Manager at Teva Pharmaceuticals for over 10 years and as Instrumentation lab supervisor at Land O’ Lakes. Meena has also worked for Agriculture and Health Canada in several technical capacities for about 10 years before immigrating to the United States.
Meena made the transition to the medical device industry after completing a MS in Regulatory Affairs for Medical Devices through St. Cloud State University in 2010. Meena has played a key role in quality system implementations in the food, pharma, and medical device industries. Meena has participated as the lead supplier/internal/GMP auditor in several Compliance audits in the US and abroad. She has a strong auditing background in the pharmaceutical and medical device auditing. Meena is a senior member of ASQ (American Society for Quality) and is ASQ certified CQA (Certified Quality Auditor), CBA (Certified Biomedical Auditor), CQIA (Certified Quality Improvement Associate), and CMQ/OE (Certified Manager of Quality/Organizational Excellence). She has been serving as an instructor for these ASQ certification classes since 2006 and has conducted quality and medical device related training classes in her current position at Baxter.
Meena is a coauthor of the CBA (Certified Biomedical Auditor) primer for the Quality Council of Indiana. She is currently an adjunct instructor for the medical technology quality program at St. Cloud State University in Minnesota. Ms. Chettiar received her M.S Regulatory Affairs and Services for Medical Devices from St. Cloud State, Minnesota, M.S. in Chemical engineering from University of British Columbia and her B.S. and M.S in Applied Chemistry from the University of Madras, India. Meena is happy to teach webinars for the Compliance Trainings and continue to contribute towards quality and regulatory compliance.