Walter E. Murray
Walter E. Murray
Walt Murray is the CEO of ARCexperts (Audit/Risk/Compliance), providing expert consulting and training for technical science-based companies. He serves as an independent consultant with multiple clients in Pharma, Medical Device, IVD and retail consulting on regulated products. He has an extended network of healthcare, software and food & beverage team consultants.
Walt Murray is a management systems (OEHSMS) and regulatory affairs (QA/RA) professional with more than 32 years of experience working with internationally recognized, highly regulated companies in automotive, aerospace, chemical, medical device, biomedical and pharmaceutical sectors. A Six Sigma Black Belt, Walt is certified (CSSMB) in quality and environmental systems auditing (CLA), Critical-Thinking Skills (CTS), Process Control and as a PMO. He also has extensive training and consulting expertise in Quality Event (QEM)/CAPA management, risk management, supplier control and audit management.
Having personally performed more than 350 1st/2nd/3rd-party audits, for a variety of Fortune 500 companies as well as hosted investigational and systems audits by the FDA, Therapeutic Goods Administration (TGA), Medicines and Healthcare Products Regulatory Agency (MHRA) and Health Canada (CMDR) due to vast knowledge of regulation and guidance documentation and quality standards. This includes guidance on the MDSAP process for auditing.
Walt holds a Bachelor of Science degree in analytical chemistry from the University of Richmond, VA and has completed graduate-level coursework at the University of Tennessee, Knoxville (Deming School). He is an active member of the Society of Manufacturing Engineers (SME), the Regulatory Affairs Professional Society (RAPS), the American Society for Quality (ASQ) and the Society for Quality Assurance (SQA). He was the founding Executive Director of the Mfg. Council of the Central Valley of CA.(MCCV).
Walt has assisted in the strategic development of Enterprise Software with validation support in life science companies. He recently lead the quality and compliance consulting services division of MasterControl®, a leading provider of quality management software enterprise to regulated companies worldwide. His broad knowledge base makes him a sought-after speaker at national and international compliance forums. He is a Vietnam Veteran where he served as a corpsman and certified laboratory technologist.
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Med Device Transitions, MDSAP-ISO13485-GMP Convergence
The convergence of GxP for GMP Auditing to an integrated system is just around the corner. 2019-2020 are shaping up to present the quandary of what many have thought but any have not done to plan for what’s coming... -
Risk-Reduction Practices in Clinical Trials
CQMS (Clinical Quality Management System) is designed to manage all of the documents, activities, project tasks, processes, quality events, risk considerations, relationships, audits and training that must be administered and controlled throughout the life of a clinical trial. The... -
CAPA Training related to FDA Causal Warning Letters
The number one citation for the FDA 11 years running has been the issue of CAPA control and resolution. It was barely surpassed recently by Product and Process Control (P&PC) because of the inherent technology boom and the reduction... -
Effective Deviation Investigation
All regulated life science companies have a requirement to provide a process for systematically performing investigations in any channel of the organization. This is true especially when it comes to unplanned deviations such as customer complaints, product non-conformances, material... -
Medical Device Single Audit Program (MDSAP) – All You Need To Know
What is MDSAP and where it is going? Will it eventually touch my business anywhere in the world? MDSAP is creating a playing field among regulatory bodies around the world. That playing field consists of the 6 critical regulatory...
