A to Z of Supplier Management in the Medical Device Industry

Description :

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 bio=-compatibility 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