• 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

• Identify efficiently the main issues and relevant situations in a set of information.
• Analyze the relevance of the identified issues in relation to the main topic to be communicated.
• Summarize initial ideas succinctly and clearly to facilitate understanding and analysis.
• Organize information using concept mapping techniques to visualize relationships between findings and the main theme.
• Use key language steps to synthesize information effectively and accurately.
• Identify ambiguity and redundancy in information and apply techniques to eliminate them.
• Apply principles and methods to identify information effectively and exercise good judgment in the synthesis process.

Course Content

1. Identification of the main issue/situation
   • Identification of relevant issues
   • Initial Idea Summary
2. Organizing the Information
   • Conceptual Idea Mapping
   • Establishing relationships between discoveries and main issue to be communicated
3. Summarizing Information
   • Key Language Steps
   • Identifying ambiguity and redundance
   • Techniques principles and methods for identifying information effectively and with good judgement

At The End Of The Course You Will Be Able To

• Understand the notion of risk and its relevance in the context of the medical devices industry.
• Become familiar with the legal and regulatory requirements related to risk management in the medical field.
• Learn the key terms and definitions related to risk management, establishing a solid knowledge base.
• Explore the principles and guidelines of ISO 14971:2019, which is used for risk management in medical devices.
• Learn about common tools used to control and mitigate risks associated with products and production processes.
• Learn how to effectively maintain and update risk documentation to ensure it is current and accurately reflects the current situation.
• Understand how to assess and manage residual risk in a global context, taking into account all factors involved in medical devices risk management.

Course Content

1. What is Risk and the importance for medical
   • Welcome to Course, Presentations and Outline Review
   • Real world RM Case Example
   • Risk Concept Definition
2. Regulatory Requirements for Risk Management
   • ISO 13485:2016
   • Medical Device Directive (MDR)
   • FDA - 21 CFR 820
3. Key Terms and Definitions
4. Overview of ISO 14971:2019
5. Typical Product and Production Risk Control Tools
   • Risk Management in Product Design
     • Preliminary Hazard Analysis
     • Hazards Analysis
     • Use FMEA
     • Design FMEA
   • Risk Management in Production
     • Process FMEA
6. Risk Documents Sustaining and Update
   • Production and postproduction activities
     • Production Feedback
     • Post Market feedback (Complaint handling, Service reports, Field studies, Scientific Literature)
     • Risk Documents Sustaining and Update
7. Overall Residual Risk
   • Individual and Overall residual risk

At The End Of The Course You Will Be Able To

• Know main concepts required for data collection and statistical analysis.

• Use and interpret descriptive metrics such as mean, mode, median, variance, standard deviation, quartile, percentile, and range.

• Use of graphs to describe and rationalize data behaviors.

• Recognize the graphs that are better fit to use under different situations.

• Use graphs to recognize suspicious data behaviors or data collection mistakes that could affect the data credibility, for instance outliers, data from mixed populations, truncated data or rounding problems.

• Identify if a sample mean is statistically similar or not to a reference value through hypothesis testing.

• Make decisions through the interpretation of data from applied examples.

Course Content

• General concepts
• Bias
• Population and sample
• Skewness
• Kurtosis
• p-value

• Central tendency metrics
  • Mean
  • Median
  • Mode
• Variability Metrics
  • Standard deviation
  • Variance
  • Percentiles and quartiles
  • Z Values

• • Histogram
  • Boxplot
  • Bar Chart
  • Individual plot
  • Interval
  • Time series
  • Scatter plots

• Understand the general connection and differences between the ISO 13485 and the 21 CFR Part 820.

• Know key factors to comply and maintain compliance to the ISO 13485.

• Understand how a company’s quality management system fulfils and is connected to the ISO 13485.

• Learn to interpret ISO 13485 general requirements in the specific context of the medical device industry.

• Learn the general requirements from each clause of the ISO13485 and how they correlate to the company quality system and procedures.

• Experience and apply ISO 13485 requirements to solve real case situations during the class that a professional in this industry could face to maintain compliance.

Course content

1. Overview
2. Quality management system
3. Management responsibility
4. Resource management
5.  Product realization
   • Planning of product realization
   • Customer-related processes
   • Design and development
   • Purchasing
   • Production and service provision
   • Control of monitoring and measuring equipment
6. Measurement, analysis, and improvement
   • Monitoring and measurement
   • Control of nonconforming product
   • Analysis of dataImprovement

At The End Of The Course You Will Be Able To

• Understand the importance, purpose, and the framework of general requirements for the design and manufacture of medical devices per FDA 21 CFR Part 820 regulation (QSR).
• Key factors to comply and maintain compliance to the QSR.
• Understand how the company’s quality management system fulfils and is connected to the FDA QSR.
• Learn the general requirements from all Sub-parts of 21 CFR Part 820 and how they correlate to the company quality system to support day-to-day activities.
•  Experience and apply FDA QSR requirements to solve in class real case situations that could be faced by a professional in this industry and to maintain compliance according to the standards.

Course Content

1. Overview
2. Subpart B—Quality System Requirements
3. Subpart C—Design Controls
4. Subpart D—Document Controls
5. Subpart E—Purchasing Controls
6. Subpart F—Identification and Traceability
7. Subpart G—Production and Process Controls
8. Subpart H—Acceptance Activities
9. Subpart I—Nonconforming Product
10. Subpart J—Corrective and Preventive Action
11. Subpart K—Labeling and Packaging Control
12. Subpart L—Handling, Storage, Distribution, and Installation
13. Subpart M—Records
14. Subpart N—Servicing
15. Subpart O—Statistical Techniques

At The End Of The Course You Will Be Able To

• Understand the regulatory framework of medical device manufacture.
• Have a general understanding of what Good Manufacturing Practices (GMPs) are and why they  are relevant for the Medical Devices Industry to ensure compliance to the quality system.
• Learn key concepts of GMP for the manufacture of medical devices, such as:
  • Personnel
  • Cleanliness and Hygiene
  • Productive Process
  • Documentation
  • Quality Assurance

• Understand the importance of maintaining a contaminant-free environment.
• Learn about quality and discuss how quality products are important for safety and efficacy.
• Understand the importance of GMP audits and how they can help companies to comply with guidelines set by regulatory authorities.

• Apply GMP requirements and gain knowledge to solve multiple real case situations throughout each class.

Course Content

1. GMPs Overview
2. What are Good Manufacturing Practices
3.  Key Elements in GMPs
   • Personnel
   • Cleanliness and Hygiene
   • Productive Process
   • Documentation
   • Quality Assurance

• Develop general understanding of what Good Documentation Practices (GDPs) are and why they are relevant for the Medical Devices Industry to ensure compliance to the quality system.

• Learn about key concepts of GMPs for data records elements such as:
  • Data Accuracy
  • Data Integrity
  • Precision
  • Time
  • Legibility
  • Identifiability

• Learn about Good Documentation Standards and the best practices for:
  • Creation
  • Approval
  • Signatures
  • Handwritten Entries
  • Document modification, corrections and review.

• Apply GDP requirements and gain knowledge to solve multiple real case situations through out the class.

Course Content

1. What are Good Documentation Practices.
2. Data Record Elements:
   • Data Accuracy
   • Data Integrity / Validation
   • Time
   • Legibility
   • Identifiable
3. Good Documentation Standards
   • Creation
   • Approval
   • Signatures
   • Handwritten Entries
   • Corrections
   • Review

At The End Of The Course You Will Be Able To

• Understand the purpose of Process Validation (PV) in the medical device industry.
• Learn about the difference between the concepts of verification and validation as per ISO 13485 and 21 CFR Part 820 requirements.

• Learn about key process validation elements and their purpose for:
  • Validation Master Plan (VMP)
  • Equipment Qualification (EQ)
  • Test Method Validation (TMV)
  • Operational Qualification (OQ)
  • Performance Qualification (PQ)

• Understand the importance of other elements associated to process readiness such as:
  • Manufacturing Readiness
  • Risk Management
  • Material Readiness
  • System Setup
  • Facilities Setup

• Learn about the Process Validation Lifecycle – State of the Art.

• Apply the class learning to solve real life cases associated to process validation.

Course Content

1. Purpose of Process Validation.
2. Process Validation from the Regulation Perspective.
3. Elements of Process Validation (EQ, OQ, TMV, PQ).
4. What is the starting point (MVP).
5. Other Elements to Get Started
6. Process Validation Lifecycle – Maintaining the state of the art.