Design Verification and Validation For Medical Devices and Combination Products
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Speaker : ALAN GOLDEN
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When : Monday, July 22, 2024
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Time : 11 : 00 AM EST
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Alan has over 35 years of experience in the medical device industry, both in basic research and in quality assurance. Alan spent 31 years at Abbott Laboratories. For the first 16 years as part of diagnostics R&D, he developed recombinant proteins used in diagnostics tests, received three US patents and published numerous papers and abstracts. Alan then transitioned to a quality assurance role where in both the Abbott Diagnostics and Abbott Molecular divisions, he was responsible for quality assurance for new product development, on-market product support and operations.
Alan’s quality assurance experience extends from design control, change control, risk management, CAPA, process and test method validation and statistics. He has been lecturing on these topics worldwide for over 20 years.
Alan retired from Abbott in 2018 and now runs Design Quality Consultants, providing training, workshops and seminars in many areas of quality assurance.
Alan received his BS degree in Microbiology from the University of Michigan and his MS degree in Molecular Biology and Immunochemistry from the University of Illinois.
Verification and validation of design inputs is a critical step in the development of medical devices. It is the objective evidence that the developer developed what they set out to develop and the final product meets its design goals and needs of the end user. Without proper verification/validation of inputs, it is not possible to prove to regulatory agencies that you have a product which is safe and effective and that it meets its design requirements.
Areas Covered
- Overview of where inputs (requirements) and V&V fit into the general flow of design control
- Regulatory Requirements
- A look at Design Inputs
- Where do they come from
- Flow
- Traceability - Verification of Product Requirements
- Validation of User Needs
- Trace matrix and summary reports
- Conclusions
Who Should Attend
This webinar is appropriate for anyone working in the design, development, marketing, or support of regulated medical devices. People working in R&D, Quality Assurance, Validation, Regulatory Affairs, Marketing, Production, and Product Support will benefit from this information.
Why Should You Attend
In the development of medical devices, incomplete understanding and implementation of design controls will lead to the rejection of an application for approval by the FDA or rejection of a CE mark application. Incomplete, improper or missing verification and validation is a cause of many products not being approved for the market. This webinar will give the participants the basics to be able to work through the concepts of design verification/validation and implement these concepts in their respective areas.
Topic Background
Overview of design control for medical devices with and emphasis on verification and validation of design inputs. The webinar will cover basic regulations regarding verification/validation of inputs, trace of inputs to verification/validation, and techniques including statistics for proper verification/validation of design inputs.
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$199.00
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