Areas Covered in the Session :
- Key changes to the ISO 13485:2016
- Effective Gap Assessment with ISO 13485
- Updating your procedures to ensure compliance on an ongoing basis
- Observing every individual element that had been enhanced under ISO 13485: 2016
- Successfully auditing to the new standard (closing all CAPAs from the audit)
- Changes in the control of nonconforming products and CAPA expectations
- Training employees with the new procedures to ensure compliance to the new ISO standard?
- Smart tips to ensure implementation and maintenance of the changes in your QMS
- EU Notified-Body expectations under ISO 13485: 2016 and the MDR – with the recent major revisions to both
- How can a company develop and maintain a dual QMS (EU and USFDA) and prepare for additional Geographies associated with MDSAP?
- Alignment of MDSAP for ISO13485:2016 for readiness to expand your market
- Discussion of ISO 14971 (Device Risk Management) and IEC 62366-1 (Use Engineering / Human Factors) and where they fit
- Maintaining overall compliance under increasing regulatory expectations
- Similarities and differences in the FDA and ISO13485:2016, after FDA has taken the path of MDSAP how do you continue to comply to ISO13485:2016?
Who Should Attend:
- Quality Assurance Departments
- Quality Control Departments
- Regulatory Affairs Departments
- Research and Development Departments
- Manufacturing Departments
- Engineering Departments
- Operations Departments
- Supplier Management Teams
- Auditing Management Teams
- QA/QC CAPA Admins
- ISO 13485 Implementation Team Members
- Suppliers to medical device industry
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.