Course Description

This course provide a comprehensive understanding of the procurement process within the context of the medical device industry. Throughout the program, participants explore the strategic importance of procurement, its main activities, and the complete supply cycle. The course addresses key topics such as demand management, inventory, cost analysis, purchase planning, and risk management, applying practical tools and approaches to each stage. Additionally, it emphasizes the relevance of regulatory compliance, the relationship with nonconformities and corrective actions (CAPA), and specific requirements of the medical device industry, such as ISO 13485 and 21 CFR 820. Upon completion, students will be able to analyze, plan, and optimize the procurement process with a focus on quality, efficiency, and regulatory compliance.

At The End Of The Course You Will Be Able To

• Recognize the importance, terminology, and cycle of purchasing within an organization.
• Analyze demand management.
• Analyze relationship management, sourcing, and agreements.
• Analyze inventory management.
• Apply cost analysis in the context of the medical device industry.
• Apply purchase planning in the context of the medical device industry.
• Evaluate risk management in the purchasing process within the medical device industry.
• Relate nonconformities and CAPAs to the purchasing process and their interaction.
• Interpret medical device industry requirements based on how they affect the purchasing process.

Course Content

1. Intro to Procurement
   • What is procurement
   • Strategic importance of procurement
   • Procurement main activities
   • Procurement cycle
   • Main Definitions
2. Demand management
   • Independent Demand vs Dependent Demand
   • Forecasting
     • Forecast main components
     • Time series
     • Collaborative forecast
     • Other tools
   • The Planning process
     • Sales and Operations Plan
     • Production Planning
     • MRP
3. Inventory Management
   • Production systems (MTO,MTS, ATO, DTO,etc)
   • Inventory types and functions
   • Components of inventory-related decisions
   • Inventory Cost
   • ABC Analysis for inventory Management
   • XYZ Analysis for inventory Management
   • Inventory Policies
   • Inventory Performance and control
   • Supply Chain decisions and characteristics impact  on inventory
   • Orders parametrization impact on inventory
4. Cost Analysis
   • Classical costs/Spends in a manufacturing environment
   • Collecting Cost Data
   • Categorizing Cost Data
   • Analyzing Cost Data
   • Cost saving opportunities analysis
5. Procurement Planning
   • Factors to consider
   • Procurement Plan
   • Monitoring
6. Procurement risk management
   • Sources of risk
   • Type of Procurement Risks
   • Risks Mitigations
7. Performance Management
   • Key Financial Indicators related to inventory
   • Key Performance Indicators related to inventory
   • Key Financial Indicators related to Procurement
   • Key Performance Indicators related to procurement
   • Continues Improvements
8. Nonconformities / CAPA
   • What are Nonconformities and CAPAS
   • Normative Considerations
   • Why are they important?
   • System CAPAs/NCR
   • Product CAPAs/NCR
   • How can Nonconformities and CAPAs impact Procurement
9. Medical Devices Industry Requirements
   • Supplier Requirements
     • ISO 13485 and
     • 21CFR820
   • Validated Process Conditions
   • Change Management