MATLAB and Simulink for FDA Software Validation Training by Tonex
The “MATLAB and Simulink for FDA Software Validation” training course by Tonex is a comprehensive program designed to equip professionals in the pharmaceutical and healthcare industries with the essential skills and knowledge needed to ensure compliance with FDA regulations for software validation using MATLAB and Simulink. This hands-on training will cover the critical aspects of software validation, leveraging industry-leading tools, and best practices to ensure the integrity and reliability of software applications in a regulated environment.
By the end of this training, participants will possess the knowledge and skills necessary to confidently navigate the complex landscape of FDA software validation using MATLAB and Simulink, ultimately ensuring the reliability and compliance of software systems in regulated industries.
Learning Objectives: Upon completing this course, participants will be able to:
- Learn the FDA regulations and guidelines related to software validation.
- Effectively utilize MATLAB and Simulink for software validation processes.
- Develop and execute validation protocols and test cases using MATLAB and Simulink.
- Identify and mitigate common compliance and validation pitfalls.
- Integrate MATLAB and Simulink into the software development life cycle.
- Apply practical skills to enhance software validation efficiency and accuracy.
Audience: This course is ideal for professionals working in the pharmaceutical, healthcare, and medical device industries, including:
- Quality Assurance Managers
- Regulatory Affairs Specialists
- Software Developers and Engineers
- Validation Engineers
- Compliance Officers
- Project Managers
- Research and Development Professionals
Course Outline:
Introduction to FDA Software Validation
- FDA Regulations and Guidelines
- Importance of Software Validation
- Role of MATLAB and Simulink in Compliance
Software Validation Planning
- Creating a Validation Plan
- Risk Assessment and Mitigation
- Validation Documentation Requirements
Using MATLAB for Validation
- MATLAB Fundamentals for Validation
- Data Analysis and Visualization
- Scripting for Test Automation
Simulink for Software Validation
- Simulink Basics for Validation
- Model-Based Testing
- Simulink Validation Techniques
Creating Validation Protocols
- Defining Test Cases and Scenarios
- Test Script Development
- Execution and Reporting
Validation Process Integration
- Incorporating MATLAB/Simulink into SDLC
- Ensuring Traceability and Compliance
- Continuous Validation and Maintenance