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

• Grasp the sources and causes of variation when taking measurements, enabling them to identify and mitigate potential sources of error.
• Learn how to plan, execute, and analyze Measurement System Analyses, ensuring robust measurement processes and reliable data collection.
• Gain practical experience in executing MSA procedures, enhancing their ability to implement best practices and improve measurement accuracy and precision.
• Understand different types of MSA, including destructive and non-destructive methods, and be able to select and apply the most appropriate approach for their specific measurement needs.

1. Sources of variation when taking a measurement:
   • Instrument calibration
   • Resolution
   • Accuracy
   • Bias
   • Stability over time
2. Causes of variation
   • Variation of operators
   • Part Part variation
   • Environmental variation
   • Random variation
   • Systematic variation
   • Sampling variation
3. MSA attributes
   • How to plan it
   • How to execute it
   • Analysis
4. MSA variables
   • Type of MSA
     • Destructive
     • Non-destructive
   • Plan
   • Execution
   • Analysis

At The End Of The Course You Will Be Able To

• Understand the importance of proper packaging for medical devices.
• Recognize and apply the relevant standards and regulatory requirements in the manufacture and packaging of medical devices, ensuring compliance with the necessary quality and safety standards.
• Evaluate and understand the properties of the materials used in the packaging of medical devices, ensuring the right choice to guarantee the protection and integrity of the product.
• Identify and address common problems related to medical device packaging and implement efective solutions to prevent or resolve quality and safety issues.
• Calculate and manage the shelf life of medical device packaging, considering factors such as material degradation and storage conditions, to ensure ecacy and safety over time.
• Understand the sterilization methods used in medical device packaging, identify the risks associated with contamination, and be prepared to apply appropriate sterilization methods in the packaging process.

Course Content

1. Introduction to Medical Device Packing
2. Applicable Standards and Requirements
3. Packaging Materials
4. Common Issues
5. Packaging Shelf Life
6. Sterilization Overview

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

• Learn about a solid understanding of the Validation Master Plan, the typical content and requirements captured in this document and the regulatory requirements associated to the medical device manufacturer associated to process validation planning.

• Know the typical process phases of equipment validation going from defining the requirements for construction to installation and qualification.

• Know the different elements and best practices of the OQ and apply the acquired knowledge in the elaboration of an OQ protocol.

• Know through the different elements and best practices of the PQ and apply the acquired knowledge in the elaboration of an PQ protocol.

• Guide the student through the different elements associated to the VMR.

Course Content

1. Process Validation Principles
   • Purpose of process validation
   • Process validation from the regulation perspective
   • Elements of process validation (EQ, OQ, TMV, PQ)
   • What is the starting point (VMP)
   • Other elements to get started
   • Process validation lifecycle – Maintaining the state of the art
2. Equipment Qualification
   • What is equipment qualification
   • Typical steps to validate and qualify equipment
   • User Requirement Specifications (URS)
   • Factory Acceptance Test (FAT)
   • Installation Qualification (IQ)
   • Best practices for equipment qualification and validation
3. Operational Qualification
   • Elements of operational qualification
   • Operational qualification phases
   • Definition of worst cases scenarios
   • Definition of sampling plans based on risk indexes
   • Execution requirements
   • Data analysis
   • Best practices
4. Performance Qualification
   • Elements of performance qualification
   • Performance qualification phases
   • Definition of worst cases scenarios
   • Definition of sampling Plans based on risk indexes
5. Validation Master Report
   • Purpose of the VMR
   • Validation Master Report
   • Typical content and sections
   • Considerations when creating and VMR
   • Class example of VMR

At The End Of The Course You Will Be Able To

• Understand the purpose of Test Methods Validation in the medical device industry.
• Learn about calibration terminology and methods.
• Explain the various components of a calibration system.
• Understand the concepts, applications and tools necessary for test method validation to comply with requirements of the FDA’s Quality System Regulation and ISO 13485 and other regulatory requirements.
• Learn about appropriate and effective methods of implementing Test Method Validation.
• Understand common issues you might find in Test Method Validations.Experience in a practical way, real-world situations, and examples that a professional working for this industry could face.

Course Content

1. Calibrations Overview
   • Definitions
   • Purpose
   • Calibration Methods
   • Calibration Inputs
   • Calibration Procedures
2. Test Method Validations
   • Definitions
   • Concepts
   • Applications
   • Tools
   • Validation
   • Pitfalls

At The End Of The Course You Will Be Able To

• Understand the concepts of change control in the medical device industry.
• Understand an overview of the medical device change control and regulatory and quality management system (QMS) compliance.
• Understand the types of changes according to different criteria.
• Learn the elements of the impact assessment in medical device change control process.
  • Change Description
  • Scope of Chance
  • Risk Assessment
  • Validation Assessment
  • Production and Process Assessment
  • Regulatory Assessment

• Experience in a practical way, real-world situations, and examples on change control.

Course Content

1. Regulatory Requirements
2. Definition of Change
3. Change Workflow
4. Change Types
5. The Impact Assessment
   • Change Description
   • Scope of Chance
   • Risk Assessment
   • Validation Assessment
   • Production and Process Assessment
   • Regulatory Assessment

At The End Of The Course You Will Be Able To

• Learn and apply the 8D process and supporting tools through hands-on working sessions.
• Understand and use of the 8D methodology approach for problem solving.
• Learn to describe the problem statement in terms the who, what, where, when, why, how, and how many (5W2H) for the problem.
• Define and implement containment actions to isolate the problem.
• Identify all applicable causes that could explain why the problem occurred.
• Define and implement corrective actions (CA).
• Take permanent corrective actions, so that the problem does not come back again.
•  Apply the knowledge acquired to solve real case situations throughout the class.

Course Content

1. Root Cause Analysis Concepts
   • Cause and effect relationship
   • Contributing factors
   • Understanding a problem-solving vs a continues improvement opportunity
   • Case study
2. D1 – Team formation
   • The importance of defining a team
   • How to select the appropriate personnel
   • Skills to consider when putting together the team.
3. D2 – Definition of the problem
   • Applying the 5W+H concepts the who, what, where, when, why, how, and how many (5W2H) for the problem.
   • Analytical tools
     • Data Collection
     • Control Charts
     • Check sheets.
     • Paretto Charts
     • Flowcharts
     • Histograms
     • Characterizing the Problem
     • IS/IS NOT
   • Defining the problem statement
   • Common issues when defining the problem
   • Case Study
4. D3 – Implementation of containment actions
   • Considerations when implementing containment actions.
   • Choosing the appropriate containment actions
5. D4 – Identification of the root cause
   • Root cause identification tools
     • Brainstorming
     • Cause and effect diagram
     • The 5 Whys
   • Analyzing and understanding data
     • Data types
     • Affinity data analysis
       • Regression analysis
       • Probability techniques
         • Sampling
         • Probability distribution identification
   • Developing and validating Hypothesis
6. D5 – Development and verification of solutions
   • Confronting solutions to IS/IS NOT
7. D6 – Implementation of corrective actions
   • Assessing the solution paths
   • Decision matrix
   • Mistake proofing methods
8. D7 – Prevention of recurrence of the problem
   • Verification of effectiveness
   • Preventive actions
   • Confirming solutions
9. D8 – Team Recognition

At The End Of The Course You Will Be Able To

• Learn and apply the DMAIC methodology and supporting tools through hands-on working sessions.
• Understand and use the DMAIC methodology as an approach for process improvement.
•  Clearly define the problem or opportunity for a process improvement.
• Collect data and quantify the current state of a process.
•  Identify the root causes of process issues or variations.
• Develop and implement solutions to address the identified root causes.
• Establish controls and monitoring mechanisms to ensure that a process remains stable and continues to meet the desired performance levels.

Course Content

1. Introduction to Six Sigma and DMAIC as a process improvement approach.
2. DMAIC Methodology

• • Define
  • Measure
  • Analyse
  • Improve
  • Control