This webinar will provide valuable assistance and guidance for medical device companies to ensure they have a well defined, deployed and enforceable design validation program. Did I make the right product and can I prove it is Design Validation! Device manufacturers need to establish and maintain procedures for validating the device design. Design validation has to be performed under defined operating conditions on initial production units, lots, or batches, or their equivalents. Design validation must ensure that the company’s device or devices conform to defined user needs and intended uses and will include testing of production units under actual or simulated use conditions.
It will also include software validation and risk analysis, where appropriate. The results of the design validation, including identification of the design, method(s), the date, and the individual(s) performing the validation, must be documented in the company’s Design History File or known as the DHF. Whereas verification is a detailed examination of aspects of a design at various stages in the development, design validation is a cumulative summation of all efforts to assure that the design will conform to user needs and intended use(s), given expected variations in components, materials, manufacturing processes, and the use environment.
It will also include software validation and risk analysis, where appropriate. The results of the design validation, including identification of the design, method(s), the date, and the individual(s) performing the validation, must be documented in the company’s Design History File or known as the DHF. Whereas verification is a detailed examination of aspects of a design at various stages in the development, design validation is a cumulative summation of all efforts to assure that the design will conform to user needs and intended use(s), given expected variations in components, materials, manufacturing processes, and the use environment.
Areas Covered in the seminar:
- Learn how to use a design FMEA to support that you did use risk analysis during design and development.
- Design validation is not process validation: did we design the right product?
- Understand the components of validation planning, review, methods and all of the required documentation.
- Why design control does not end with the transfer of a design to production.
- Why it encompasses verification and extends the assessment to address whether your devices produced in accordance with the design actually satisfy user needs and intended uses.
- Why FDA will take a 'hard look' at design validation.
- Identify what goes into your design validation procedure to make it bulletproof.
- Understand and apply real life examples of risk analysis or hazards analysis tools such as FMEA.
Who Will Benefit:
This webinar will provide valuable assistance and guidance for medical device companies to ensure they have a well defined, deployed and enforceable design validation program. The employees who will benefit include:- All levels of Management for all departments and those who desire a better understanding or a 'refresh' overview.
- QA/QC/Compliance/Regulatory Affairs
- Marketing & Sales
- Design Engineering/R&D/Technical Services
- Consultants
- Operations and Manufacturing
Course Provider
David Dills,
