Design Verification and Validation

This webinar focuses on regulatory compliance for medical devices, with a strong emphasis on verification and validation of design inputs. Gain insights into essential regulations, tracing inputs to verification/validation, and utilizing statistical techniques for effective validation.

Inadequate design control can jeopardize FDA approval and CE mark applications for medical devices. Many products face market rejection due to incomplete or improper verification and validation. Our seminar equips participants with fundamental knowledge to navigate design verification and validation concepts, ensuring implementation in their respective roles.

Design input verification and validation are pivotal stages in medical device development, providing tangible proof that the product aligns with its intended design and user needs. Without these critical steps, regulatory agencies can't ascertain a product's safety, efficacy, and adherence to design requirements.

Areas Covered in the Session :

• Overview of design control flow and were verification and validation fit in
• Basic trace from inputs to verification and validation
• Methods of verification and validation of inputs including statistics
• Writing protocols and records
• Discrepancies and deviations
• Trace matrices form inputs to outputs

Who Should Attend:

• Quality Assurance Departments
• Quality Control Departments
• Regulatory Affairs Departments
• Research and Development Departments
• Manufacturing Departments
• Engineering Departments
• Operations Departments
• Production and Product Support Personnel
• Professionals in Design, Development, Marketing or Support of regulated medical devices.

Course Director: ALAN M. GOLDEN

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 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.