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 problems, OOS’s, design challenges, and many other “channels”.

This process will be described in terms of notice of event (NOE) escalation, and the importance that risk-gating and review of data/information is utilized in critical thinking processes (CTS). We will introduce the (5) CTS processes and how they compliment each other in effective resolution during the investigation of deviations. The context of this discussion will be in support of the CAPA process and citations for poor investigations.

Areas Covered in the Session :

  • Deviation Investigation process
  • Context of CAPA with this process
  • The connection of the deviation spectrum to risk, data analysis and process resolution which includes change control
  • Brief descriptions of the (5) CTS models and their interaction
  • FDA citations that bear out the failures with such investigations
  • Tools/resources used to support such processes
Who Should Attend:

  • Senior Management
  • Middle Management
  • Quality Departments
  • Regulatory Affairs Departments
  • R&D Departments
  • Operations Departments
  • Production Departments
  • Manufacturing Departments
  • Engineering Departments
  • Marketing Departments

FDB2391

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.

JUST RELEASED
SEMINARS
&
WORKSHOPS
 



Untitled1


  • Login Information with Password to join the session, 24 hours prior to the webinar
  • Presentation Handout in .pdf format
  • Presentation from the Speaker
  • Feedback form
  • Certificate of Attendance
  • 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
.