Design Verification and Validation (V&V) for U.S. Manufacturing Essentials Training by Tonex
This course equips engineers with the comprehensive knowledge and practical skills needed to execute robust V&V processes for U.S.-compliant product launches. We delve into meticulous verification planning, detailed test case development, and the crucial regulatory V&V documentation. Furthermore, we address the growing concern of cybersecurity, ensuring V&V incorporates security testing and risk mitigation. This course empowers you to minimize risks, ensure compliance, and accelerate time-to-market.
Audience:
- Manufacturing Engineers
- Quality Assurance Engineers
- Regulatory Affairs Professionals
- Design Engineers
- Project Managers
- Cybersecurity Professionals
Learning Objectives:
- Develop comprehensive verification plans.
- Create effective test protocols and ensure traceability.
- Design robust test cases for manufacturing products.
- Understand and apply relevant U.S. regulatory requirements.
- Generate accurate and compliant V&V documentation.
- Integrate cybersecurity considerations into V&V processes.
Course Modules:
Module 1: Verification Planning and Fundamentals.
- Introduction to V&V principles and methodologies.
- Developing comprehensive verification plans.
- Establishing traceability matrices.
- Risk assessment and mitigation strategies.
- Understanding U.S. regulatory frameworks (FDA, etc.).
- Document control and management.
Module 2: Test Protocol Development.
- Creating detailed test protocols.
- Selecting appropriate testing methodologies.
- Defining acceptance criteria.
- Utilizing statistical process control.
- Integrating cybersecurity tests into protocols.
- Managing test equipment and resources.
Module 3: Test Case Design and Execution.
- Developing effective test cases.
- Performing functional and performance testing.
- Implementing regression testing.
- Security testing for vulnerabilities.
- Documenting test results and deviations.
- Analyzing test data and reporting findings.
Module 4: Regulatory V&V Documentation.
- Understanding FDA and other regulatory requirements.
- Creating compliant V&V documentation.
- Managing change control processes.
- Preparing for regulatory audits.
- Cybersecurity Documentation for compliance.
- Maintaining accurate records and logs.
Module 5: Cybersecurity Integration in V&V.
- Understanding cybersecurity risks in manufacturing.
- Integrating security testing into V&V processes.
- Addressing data integrity and privacy concerns.
- Implementing security best practices.
- Responding to security incidents.
- Validating security controls.
Module 6: Advanced V&V Techniques.
- Applying advanced testing methodologies.
- Performing design of experiments (DOE).
- Implementing automated testing tools.
- Managing complex V&V projects.
- Continuous improvement of V&V processes.
- Preparing for product lifecycle V&V.
Enroll today to master U.S. manufacturing V&V and ensure your products meet all regulatory and security standards.