CAPA Training related to FDA Causal Warning Letters

  • Product Id : FDB2392
  • Category : , ,
  • Presenter :
  • Scheduled On : March 20 2018 1:00 pm
  • Duration : 60 Minutes

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 of the human factor with the use of product and process software. CAPA is an engrained systematic approach to successfully improving processes and their integration in quality system (QSR).

The way that regulators get a handle on the scope and use of such a system is the inherent yet pragmatic application of CAPA. Internally this approach plagues many organizations due to the lack of balance for between the process of handling a CAPA and the intelligence factor of the team or person responsible for facilitating effective resolution.

Areas Covered in the Session :

  • CAPA in the context of a QMS
  • CAPA and its intent: fix-it, improve it, innovate
  • CAPA: The human factor and the use of tools vs. process
  • Analysis of Warning Letters in the context of poor process and communication
  • Interactive Q&A Session
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
  • Validation Departments
  • Trial Audit Function
  • IRB Members

FDB2392

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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  • Presentation Handout in .pdf format
  • Presentation from the Speaker
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  • Presentation Handout in .pdf format
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