Walt Murray, Principal Pinpoint Services (PPS)
Walt Murray is a quality management and regulatory affairs professional with more than 35 years of experience working with internationally recognized, highly regulated companies such as J&J (DePuy), Grifols, GEHC, Thermofisher, McKesson, Juno Therapeutics and United Therapeutics. A Master Six Sigma Black Belt, Murray is certified in quality, laboratory and environmental systems auditing (AQS Certification/RABQSA), Critical-Thinking Skills (CTS) and process control.
He also has extensive training and consulting expertise in Quality Events/CAPA Management, Risk Management, Supplier Control and Audit Management.
Having personally performed more than 400 first, second and third-party (and MDSAP) audits, for a variety of Fortune 1000 life sciences companies, Murray has hosted investigational and systems audits by the FDA, Therapeutic Goods Administration (TGA), Medicines and Healthcare Products Regulatory Agency (MHRA) and Health Canada (CMDR).
He has assisted companies with 483’s, Warning Letters and Consent Decree’s. He routinely advises on submissions for 510k clearance especially when an RTA follows. Upon the completion of the MDSAP pilot program (2016) he consulted on MDSAP considerations/participation for Canadian business companies based in the U.S. As a Lead Auditor he has assimilated the new IMDRF procedures (IMDRF) for MDSAP audits supporting the preparation for an AO inspection. Murray builds, improves and audits quality management systems in all the Life Science sector.
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). His broad knowledge base makes him a much sought-after speaker at national and international compliance forums such as ASQ, MD&M, AdvaMed, SQA, INTERPHEX, MDDI, BARQUA and MedTech EU.
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