Design Control, Verification and Validation
Alan has over 30 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 wherein both the Abbott Diagnostics and Abbott Molecular divisions, he was responsible for quality assurance for new product development, on-market product support and operations.
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.
This workshop will explore the relationship between design inputs and the verification and validation of those inputs in design control. Design control is the process under the Quality System Regulations in the Code of Federal Regulations under which medical devices are developed. The strategy and methodology of verifying and validating design inputs, including verification of product requirements and validation of user needs is critical to ensuring the proper and appropriate product was designed and produced. The ability to properly link, trace, and document the process of verification and validation from inputs to outputs will ensure not only regulatory compliance, but development and marketing of a product needed by the market and desired by the customer.
- Overview of where inputs (requirements) and V&V fit into the general flow of design control
- Regulatory overview
- A look at Design Inputs
o Where do they come from?
- Verification of Product Requirements
- Validation of User Needs
- Trace matrix and summary reports
Course Level - This webinar would be appropriate for participants who are new to design control up to participants who have some experience with design control but ant to expand their knowledge in verification and validation practice.
Who Should Attend
Quality Assurance Professionals, R&D Scientists, Technical Support Scientists, Regulatory Affairs Professionals, Manufacturing and Production Personnel.
Why Should You Attend
This webinar will be useful to quality assurance professionals, R&D scientists, regulatory affairs professionals, design transfer teams and production personnel involved in medical device product development and support. These include medical device companies, pharmaceutical companies involved in combination products where one component is a medical devices and companies who support the above.
Inputs and the Verification/Validation of those inputs are a critical aspect of design control. Understanding the flow between inputs and
verification and validation of those inputs is the heart of design control.