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

• Identify and explain the basic concepts of the manufacturing process and its main elements.
• Describe the major events that shaped the history of manufacturing industries.
• Identify the different production systems and their main characteristics.
• Identify the main metrics used in manufacturing processes, their main characteristics, and how to use them.
• Identify the main concepts and characteristics associated with the Lean Manufacturing methodology and the application of the main tools.
• Identify the main characteristics of the MUDA concept and how to apply it.
• Explain the concept of quality and identify its main characteristics.
• Identify and use the tools commonly used for statistical quality control.

Course Content

1. Manufacturing Principles
   • Basic manufacturing definitions and concepts
   • What is manufacturing
   • Basic Component if manufacturing
2. History of Manufacturing
   • Pre-Industrial Revolution
   • Industrial Revolution
   • Lean Manufacturing
   • Manufacturing 4.0
   • Manufacturing 5.0
3. Types of Manufacturing Production Systems
   • Repetitive Manufacturing
   • Discrete Manufacturing
   • Job Shop Manufacturing
   • Continuous Manufacturing
   • Batch Process Manufacturing
4. Manufacturing Metrics
   • Productivity
   • Efficiency
   • Scrap
   • Yield
   • Line down
   • Cycle Time
   • Cost of Goods
5. Lean Manufacturing
   • How everything started
   • How lean manufacturing sees value. A different approach
6. Lean Tools
   • 5s Gemba Visual Factory VSM
7. MUDA
   • Overproduction
   • Wait
   • Transporting
   • Overprocessing
   • Inventories
   • Movements
   • Rework
8. Quality Overview
   • What is quality
   • Evolution of the definition of quality
   • Peer evaluation in the artisanal age
   • Statistical Controls
   • Quality Inspections
   • Quality management
   • Quality at the Source
9. Intro to Statistical Quality Controls
   • Prevention vs control
   • Common causes vs Special causes
   • Process control and process capability
10. Data Analysis Tools
    • Histogram or stem-and-leaf plot
    • Check sheet
    • Pareto chart
    • Cause-and-effect diagram
    • Defect concentration diagram
    • Scatter diagram
    • Control charts

At The End Of The Course You Will Be Able To

• Acquire an overview of the medical device industry. Types of products, common regulatory concepts.
• Know the generalities of the regulations applicable to the manufacture of medical devices and the requirements of quality systems.
• Understand the importance of GDPs and GMPs for medical device manufacturers, as well as the basics of auditing and non-conforming product.
• Understand the basic concepts of packaging, the most common standards and the sterilization process.

Course Content

1. Medical Devices
2. Industry Developments
3. Regulatory environment
4. ISO 13485: 2016
5. 21 CFR Part 820
6. Good Manufacturing Practices
7. Packaging considerations

At The End Of The Course You Will Be Able To

• Define what the Power BI tool is and when to use it.
• Identify the different data sources and the methodology for obtaining them.
• Apply basic Power BI functions such as connector types, basic table transformations and more complex ones such as pivoting, data grouping, combining, conditional columns, among others.
• Use Data Analysis (DAX) expressions to improve created models.
• Know the general rules for data tables.
• Create data visualizations for decision making.
• Build reports that include different types of graphics.
• Evaluate a situation based on data provided by applying the Power BI knowledge covered during the course.

Course Content

1. Introduction to Power BI
   • What is Power BI and when to use it?
   • Explanation of the benefits and uses of the product.
   • Installation and version considerations
   • Information about the available versions and how to install.
2. Getting Data
   • Data sources: databases, files, and web
   • How to connect different types of data in Power BI.
   • Remapping moved data sources
   • How to handle changes in the location of data sources.
3. Basic Functions
   • Deleting columns and rows
   • Tools to clean up unnecessary data.
   • Changing data types
   • How to adjust data to the appropriate types.
   • Filters
   • Using basic filters for visualization and analysis.
4. Complex Functions
   • Grouping, splitting, and duplicating data
   • Advanced techniques for organizing data.
   • Data Blending: Aggregating and Merging
   • Pivoting and Unpivoting Data
   • Adding Columns and Custom Columns
   • Conditional Column and Index
5. Relationships and Hierarchies
   • Model View and Relationship Management (30 minutes)
   • Types of Joins and Hierarchies
   • Working with Related Tables
6. DAX Formulas and Measures
   • Formulas and Measures
   • Introduction and practice with basic formulas and measures.
   • Quick Actions
7. Data Tables and Time Intelligence
   • Data Table Rules and Configuration
   • Automatic Date Tables and Time Intelligence
8. Visualizations
   • Matrices and Charts
   • KPIs and Spatial Intelligence
9. Managing Visualizations
   • Slicers and Drilling
   • Basic and Advanced Filters
10. Publishing and Sharing Reports
    • Publishing on the Web
    • Exporting to PDF
11. Final Project and Practice
    • Group Project Solution and Presentation

At The End Of The Course You Will Be Able To

• Gain insight into the historical context and rationale behind software validation
• Understand relevant regulations and standards.
• Be equipped to conduct change assessments and analyze the impact of changes on software validation.
• Learn software validation best practices, including tying validation to change management, testing only
• relevant software features, and validating software output.
• Adquire practical insights into software validation challenges and solutions encountered in the medical
• devices industry.

Course Content

1. Introduction: Software Denitions and Scope
2. Software Validation Regulatory Requirements
3. GAMP5
4. Software Validation Life Cycle
5. Spreadsheet Validation
6. Electronic Records (ER)-Electronic Signature (ES) Management and General principles for Data Integrity
7. QMS and Automated process equipment Software Validation
8. Software validation best practices

This course provides a comprehensive understanding of lasers applied to marking, from basic principles to practical applications and specialized maintenance. Participants will gain knowledge of the operation and essentials of lasers, explore laser-matter interaction, specific marking applications and learn safety practices. In addition, they will focus on the maintenance of fiber lasers, including necessary care. Upon completion, students will be equipped with skills to apply and maintain laser marking systems, consolidating their expertise in this technological field

At the end of the course you will able to:

• Understand the basic operation of lasers.
• Classify the dierent types of lasers and understand their applications.
• Analyze the essential parameters in the use of lasers for marking.
• Implement safety measures when working with lasers.
• Explore general laser marking applications.
• Perform typical maintenance on fiber lasers.
• Apply care necessary for optimal maintenance and performance of laser marking systems.
• Understand the relevance of laser marking machines within the industry

Main topics

• Laser Fundamentals
  • Laser definition
  • Characteristics and operation
  • Laser types
  • Parameters and propagation
• Safety
  • Laser and risk
  • Damage mechanism
  • Other hazards
  • Equipment classification
  • Control measures
• Aplications
  • Laser Marking Applications
  • Marking materials
• Laser source maintenance:
  • Typical Maintenance
  • Required Care

This course introduces participants to Programmable Logic Controllers (PLCs), providing a solid foundation in understanding and programming these essential devices in industrial automation. From a detailed introduction to PLCs to an exploration of internal architecture, terminology and numbering systems, the curriculum covers fundamental aspects of hardware, installation, and hands-on programming in Ladder language. Participants gain skills in interlocks, timers and arithmetic functions culminating in a hands-on project that consolidates their understanding and skills in PLC programming.

At the end of the course you will able to:

• Understand the internal architecture of PLCs and their associated terminology
• Identify and work with diferent types of controllers and I/O modules.
• Apply wiring principles in PLC installation and connection.
• Become familiar with memory mapping and physical I/O addressing.
• Program in Ladder language, from latching to linear and sequential programming.
• Apply concepts of digital logic, timers and arithmetic functions in PLC programming.
• Develop a final project that demonstrates their ability to apply the fundamentals of PLC programming in practical
• industry situations.

Main topics

• Introduction to PLCs
  • Definition and types of PLC.
  • Internal architecture
  • Basic concepts and terminology
  • Numbering systems
• Introduction to hardwareController
  • I/O modules
  • Special modules
  • Communication modules
  • Power supply selection
• Installation and connection
  • General wiring principles
  • Internal circuit of input module
  • NPN and PNP sensors
  • Principle of input wiring.
  • Principle of output wiring.
• Memory map
  • PLC memory layout
  • Physical I/O addressing
• Introduction to programming
  • Ladder language introduction
  • Interlocks
  • Timers
  • Basic arithmetic functions
  • Data movements
  • Basic logic programming
  • Linear and sequential programming
  • Final Project

Al final del curso usted aprenderá a:

• Conocer el entorno de dibujo de SolidWorks, así como dominar sus herramientas y
• representación y visualización
• Generar modelos tridimensionales
• Generar dibujo (planos) normalizados para la representación de modelos 3D
• Generar ensambles de partes e integrar sus relaciones de funcionamiento
• Mostrar por medio de videos y/o presentaciones el funcionamiento de los elementos
• mecánicos ensamblados

Contenido del Curso

1. Conceptos básico e interfaz de usuario de SolidWorks
2. Introducción a los croquis
3. Modelado básico de piezas
4. Creación de patrones y geometrías de referencia
5. Operaciones para la generación de sólidos
6. Herramientas de edición
7. Configuración, variables y ecuaciones
8. Dibujo (Planos)
9. Ensambles

This course is designed to provide participants with a solid understanding of the fundamentals of action planning and management as part of a CAPA. Throughout the course, participants will explore the complete project planning and management cycle, from initiation to closure. Through a combination of theory and practice, participants will learn how to develop effective action plans, monitor and control project progress, and close projects efficiently.

At The End Of The Course You Will Be Able To

• Provide engineers and other professionals in the medical device industry, with project planning knowledge and tools to support the CAPA Actions process.
• Define the role and expectations of an action planning owner.
• Learn the importance stablishing a project structure and the characteristics of a typical Action Planning phase of a CAPA.
• Learn and use the tools provided during this course to develop the different stages of the Action Planning phase of a CAPA.
• Learn how to report the project status and performance to stakeholders.

Course Content

• Management and Planning Basics
• Action Planning & Management Cycle
  • Initiation
  • Planning
  • Monitoring & Controlling
  • Closure

The Investigation Report Assessment course is designed to provide medical device industry professionals with the skills necessary to effectively and accurately complete CAPA investigation reports. From introduction to the key elements of an investigation report to analysis and action planning, this course provides a guide to developing reports that are critical to continuous improvement and product safety in the medical device industry.

At The End Of The Course You Will Be Able To

• Understand the fundamentals of an investigation report and its importance in the medical device industry.
• Follow an established process flow for research reporting.
• Identify and describe the key elements of a research report, including impact assessment, research analysis and conclusions.
• Conduct an initial impact assessment and apply techniques such as bracketing, risk assessment, and containment actions.
• Conduct a historical review to contextualize the problem and improve understanding of its origin.
• Analyze data collected during the investigation to identify significant trends and patterns.
• Clearly and concisely present research findings in a report.
• Conduct a final evaluation of the impact of actions taken and propose corrective and preventive action plans.
• Develop an effectiveness plan to monitor the implementation of corrective and preventive actions.
• Use an investigation checklist to ensure completeness and consistency in the report writing process.

Course Content

1. Introduction to Investigation Reporting
2. Process Flow
3. Key Report Elements and Purpose
4. Description
5. Impact Assessment
   • Bracketing
   • Risk Assessment
   • Containment Actions
6. Historical Review
7. Investigation Analysis
8. Investigation Findings
9. Final Impact Assessment
10. Actions Planning
    • Corrective Action
    • Preventive Action
11. Effectiveness Plan
12. Investigation Checklist