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 around Med Device quality management and compliance. Come listen regarding the predictive model for the convergence of a new regulated horizon for medical device. Learn to be prepared by setting plans in motion for an approach that will be only 2 years in the making. Medical Device as a QMS is now under the certification to ISO 13485:2016 for compliance in CANADA by Q3 2019. MDSAP will be the applicable auditing arrangement by qualified registrars. FDA has announced plans for the transition of QSR with QMS elements by 2020. Are you reading between the lines! Be prepared. Know what your path should consider!

Areas Covered in the Session :

  • Learn what the drivers are in the convergence model
  • Learn how to instigate an aggressive plan to meet the upcoming transition
  • Digest the conceptual shifts in thinking by regulatory bodies
  • Learn to adopt the “new” process/risk based approach to internal auditing
  • Learn about a new conceptual model for training planning and execution
  • Understand the adaption of supplier/contractors in the convergence model
Who Will Benefit:

  • Quality Departments
  • Regulatory Affairs Departments
  • Research and Development Departments
  • Auditing Management
  • Engineering Departments
  • QA/QC CAPA Admins
  • CMO’s
  • Operations Management
  • Management Teams
  • Problem Solvers
  • Decision Makers and Planners
  • Everyone that are required to participate in QSR/QMS planning as a regulatory requirement


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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  • Recording access Information with Password to view the webinar, will be sent 24 hours after the completion of the Live webinar.
  • Presentation Handout in .pdf format
  • Certificate of Attendance