Bonified CAPA Investigations

Duration: 90 Minutes
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Many companies receive infractions from regulators for poor investigations. As an investigation typically is the initiation of a CAPA by nature of an action to control/eliminate the recurrence of a problem/issue. The process of how to clarify a concern and initiate an investigation to effective likely cause verification, based on priorities, is the focus of this webinar. We will describe the process steps, rationale and content and importance of following this analysis as a fact-based root cause analysis to manage the outcome of likely cause(s). In many ways this is like a "for cause" audit in the design of how to capture data/documented information. An example will be used to show practical application of an A-3 format used for process (SOP) application. This process will be explained in a casual and intensive (structured) formant in the context of the event management system (AE's, SAE's, MDR's, etc.)
CAPA investigations
Instructor: Walter E. Murray
Product ID: 503630
Objectives of the Presentation
  • How to ensure a bonified problem needing an investigation for root cause
  • The proper initiation and project management of a "significant" problem/issue
  • Why the collection of data/factual-information versus inference or invalid information
  • What happens to a likely cause for verification
  • Understanding tools vs. process and where they are important in the process
  • Types of problems difficult to solve and need this process (HR example used)
Why Should you Attend
In order to solve problems every organization must know how to conduct an effective investigation, identify root causes, and implement workable corrective action in a timely manner. An effective CAPA process requires training internal investigators, who can also coach others in the organization, to employ critical thinking. The process must provide a common model and language within the organization, which allows investigators to master the process quickly and easily.

Areas Covered
  • Clarification/simplified (risk-based)
  • Risk-based decision analysis (issues in a concern)
  • Risk ranking for regulatory concern (risk analysis/reporting)
  • Process rigor and what that means
  • Rules of facilitation
  • Destructive testing of likely causes to initiate actions for Recurrence Elimination Planning (REP)
  • Debrief improvement review
Who will Benefit
  • Quality Control Personnel & Management
  • Manufacturing Personnel & Management
  • Senior Management
  • Regulatory Affairs Personnel & Management
  • Quality Assurance Personnel & Management
  • Supplier Quality Personnel & Management
  • Product/Process Development Staff
Topic Background
Effective problem resolution has been a burden to organizations and institutions for decades. The hypothesis for this approach dates back to Socrates and Protegees of that period. In our current world the state of technology that has proliferated business has complicated getting resolution ironically in a fact-based society where data rules. It is the application in method and rigor for process that makes critical thinking successful, not the know-it-alls.
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Instructor Profile:
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 consultantwith 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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