You must attend this unique webinar presented by an expert trainer to add all the necessary tools to your quality, risk management, auditing and regulatory tool kit and lay the foundation to make the switch to the brand new ISO 13485:2016 Quality System Standard requirements for Medical Devices. This early understanding and implementation of the standard requirements will help you gain an edge in the arena of competitive global medical device marketing.
You will gain a thorough insight into the specific quality system requirements of all new International ISO 13485:2016 Quality System Standard requirements for Medical Devices. This timely and extremely informative webinar will truly build your knowledge from the fundamental quality principles. It will help you grow into fulfilling the quality and regulatory requirements as a professional working for medical device manufacturers of fully assembled devices and global suppliers manufacturing critical parts for the medical device industry. All noteworthy changes implemented into this key international standard will be discussed to pave the path for implementation of the changes in your organization.
Areas Covered in the Session :
- Current vs future landscape in the ISO 13485world will be thoroughly examined
- A quick comparison of how the new standard is harmonized with 21 CRF 820 and GHTF documents will be made
- Alignment of the standard to cater to the Medical Device Single Audit Program MDSAP will be discussed
- Extension of the quality system requirements to the life cycle of the medical device
- Incorporation of customer feedback
- Alignment with ISO 9001 and discussion of timeline for full implementation of ISO 13485: 2016
- Regulatory expectations of other major growing geographies in the world
- Details on ISO 13485:2003 elements changed in the new medical device standard ISO 13485: 2016
- How risk management is incorporated into different sections of the international standard
Who Should Attend:
- Quality Assurance Departments
- Engineering Departments
- Research & Development Departments
- Quality Control Departments
- Supplier Management Departments
- Upper Management
- Manufacturing Departments
- Product Leads
- Quality Specialists
- Design Engineers and Document Control Departments
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.