ComplianceOnline

Expert Profile


Alan M Golden
Principal, Design Quality Consultants

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.

Trainings by Expert

Validation Sampling Plans
Category: Drugs and Chemicals (Pharma) , Medical Devices

Impact Assessment for Change Control
Category: All FDA Regulated Industry

Assess Impact For Supplier Change Notices
Category: All FDA Regulated Industry

Design Control for Medical Devices: Overview and Design Inputs
Category: Medical Devices

Design Control for Medical Devices Including Verification/Validation
Category: Medical Devices

How to Prepare for and Conduct a Regulatory Audit
Category: All FDA Regulated Industry

Validation Statistics for Non-Statisticians
Category: Medical Devices , All FDA Regulated Industry , GXP Pharmaceutical , GXP Medical Devices