A to Z of Supplier Management in the Medical Device Industry
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Supplier management is an integral part of any quality system in regulated industries. Quality System regulation (QSR) and ISO 13485 have specific supplier management requirements that you are answerable to. FDA is getting more rigid about supplier audits and more stringent on managing the suppliers and outside equipment manufacturers (OEM) in the medical device industry. The goal of this webinar is to educate you on the key areas that you need to focus on in the ever growing, globally important arena of supplier management in the medical device industry.
Areas Covered in the Session :
- Fundamental areas that must be focused on for supplier management
- Onboarding and sustaining suppliers
- Supplier Qualification based on
- Quality System
- Product Development Process (PDP)
- ISO
- Other regulatory certifications
- Supplier audits
- Criteria for establishing frequency of site audits
- Audit reports and follow up with SCAR (Supplier Corrective Action Requests)
- First article inspection and its correlation to:
- Pre-established SPC (statistical process control)
- CTC (critical to customer)
- CTQ (critical to quality) criteria
- Supplier process control
- Capability assessment for sample inspections
- Role of supplier quality for new product release authorization.
- Supplier’s manufacturing quality plan
- Key areas of focus for supplier quality engineers
- Role of suppliers such as testing laboratories like biocompatibility testing labs and suppliers such as sterilization facilities
- Training of suppliers to adhere to your quality expectations
- Regulatory requirements for supplier changes
Who Should Attend:
- Quality Assurance Departments
- Quality Control Departments
- Research and Development Departments
- Regulatory Affairs Departments
- Manufacturing Departments
- Engineering Departments
- Operations Departments
- Production Departments
- Supplier Auditors
- Supplier Quality Engineers
- Inspection Supervisors
- Supply Chain Departments
- Supplier Managers
- Procurement Managers
- Outside Equipment Manufacturers (OEM)
- Internal Auditors
- Everyone who deals with supply chain management for the 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. |