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Design Control for Medical Devices and Combination Products
- Overview of Design Control for Medical Devices
- Overview of design inputs (requirements)
- Regulatory aspects
- A look at Design Inputs
- Where do they come from
- Flow
- Traceability
- Design Verification
- Design Validation
Overview of the webinar
In this webinar, we will examine the overall structure of design control as it relates to the development of medical devices. Emphasis will be placed on design control flow and how aspects of design control work together. Additional areas of emphasis will be on the importance of design inputs, as well as design verification and design validation.
Who should attend?
- Quality Assurance Professionals
- R&D Scientists
- Development Scientists and Engineers
- Manufacturing Personnel and Development Engineers
- Regulatory Professionals
Why should you attend?
The concepts and implementation of design controls is required for development and manufacture of medical devices and combination products where one or more components(s) is a medical device. Failure to properly implement design control in development, manufacture can result in products not being approved for sale or removed from market. Failure to introduce and implement design controls can also result in the development of the wrong product or the right product for the wrong market.
Faculty - Mr.Alan M Golden
Alan has over 36 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 26 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 10 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.