Design Planning, Design History Files and Design Reviews
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Speaker : ALAN GOLDEN
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When : Tuesday, August 20, 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.
Design planning, use and maintenance of design history files and periodic design reviews are crucial and integral parts of design control. All development projects in the medical device space will start with design planning. Without robust planning, it is not possible to keep track of everything that is needed during the development of a medical device. The planning stage and process will lay out and define the tasks needed to complete the development process as well as define subordinate plans to keep track of related activities such as regulatory or production plans.
Proper use and application of the design history file is not only required but essential in documenting the development process. All records related to the development of a product are stored in the design history file and as such, it must be organized, accessible, searchable and secure. Finally, design reviews are key to tracking the progress of a design project and a way for management to be formally updated as to where the project stands in relation to goals and what management can do to help if there are delays or setbacks. Design reviews also serve to allow management to approve at key milestones and final product releases.
Areas Covered
- Quick review of design control flow
- Design planning
- What is it?
- Why do it?
- Aspects - Design History File
- What is it?
- Structure
- Systems
- Use - Design Reviews
- Why?
- What?
- How many?
- Who?
Who Should Attend
Medical Device professionals in R&D, QA, RA, Technical and Manufacturing.
Topic Background
Design Planning, design history file development and maintenance as well as periodic design reviews during development are critical aspects of medical device design control.
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$199.00
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