Key Areas of Focus for Supplier Management in the Medical Device Industry

Date	Nov 21, 2013
Time	01:00 PM EDT
Cost	$249.00
Online

Description : 

This course will be immensely helpful to Supplier Auditors and Supplier quality engineers who would like a deeper understanding of the fast changing medical device regulations that are pertinent to bringing in a new supplier and maintaining them in their quality system through routine supplier audits and related documentation. In addition, Quality Engineers, Regulatory Managers, Production leads/Inspection Supervisors, Marketing/ Supply Chain Department Leads, Manufacturing Engineers associated with Production Operations, Quality Control and Quality Assurance Management,Supplier Managers, Procurement Managers, OEM (Outside Equipment Manufacturers) and Suppliers to medical device industry will be able to add new tools to their tool box. Internal Auditors and R&D Engineers will also find this webinar useful for fulfilling their responsibilities in onboarding suppliers and in long term supplier management.

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 from A to Z for on-boarding and sustaining suppliers
• OEMs throughout the product life cycle to fulfill quality and regulatory requirements of your products.
• Supplier Qualification, based on their Quality System
• Product Development Process (PDP)
• ISO and other regulatory certifications
• Criticality of the products to your supply chain
• Classification of suppliers based on type of sourcing
• Classification based on your readiness to adapt if the supplier moved out of producing
• Uniqueness of the product/process to your supply chain
• Factors while auditing a key supplier during the facility audit of a supplier to your globally distributed medical devices
• Key acceptance and evaluation criteria in supplier audits.
• Criteria for establishing frequency of site audits for key suppliers.
• 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) and CTQ (critical to quality) criteria, supplier process control and capability assessment for sample inspections.
• Role of supplier quality for new product release authorization.
• Key factors to look for in Supplier’s manufacturing quality plan
• What to include in your supplier quality plan for long term protection of your device during its life cycle.
• Key areas of focus for supplier quality engineers in receiving materials (raw materials to finished goods that may just be marketed by your company)
• 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 based on nature of the products supplied (differential treatment of dock to stock items to a sole source of a patented product).
• Regulatory requirements for supplier changes and changes such as raw material or process changes at the supplier facility that may impact your product quality.

Who Will Benefit:

• Supplier Auditors
• Supplier quality engineers
• Quality Control
• Quality Assurance
• Quality Engineers
• Regulatory Managers
• Production leads/Inspection Supervisors
• Marketing/ Supply Chain Department Staff
• Manufacturing Engineers
• Production Managers
• Operations
• Procurement Managers
• OEM (Outside Equipment Manufacturers)
• Internal Auditors
• R&D Engineers
• Suppliers to medical device industry

Speaker Profile:
Meena Chettiar is a certified instructor for ASQ learning institute for CBA and an adjunct instructor for Medical Technology Quality graduate program for St. Cloud State University in Minnesota. Meena is a coauthor of the CBA (Certified Biomedical Auditor) Primer for the Quality Council of Indiana. 

She is Senior Supplier Quality Engineer at Covidien in Plymouth, Minnesota, USA. Prior to this position, Meena served as a Senior Quality Associate (Lead Auditor and CAPA Coordinator) at Baxter Bio Surgery in St. Paul, MN. Meena worked as a Senior Quality 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. 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 served as an instructor for these ASQ certification classes since 2006. 

Ms. Chettiar received her 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 very happy to present webinars for Compliance Trainings and continue to contribute towards quality and global regulatory compliance for regulated industries.