$499.99 – $599.99

Root Cause Investigation for CAPA

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From $499.99

Event Information

Location

Location

Online event

Refund policy

Refund policy

No Refunds

Event description
Root Cause Investigation for CAPA is a globally renown methodology for investigating technical performance challenges.

About this event

July 27th - 29th 2021 | 11am - 3pm EDT | Live Webinar

  • Conducted via Zoom; no downloads required to fully participate.
  • Early registration ends July 2nd 2021.
  • Visit our website to view all our upcoming events.
  • Contact Weaver Consulting (see bottom of page) for registration/payment via purchase order instead of credit card.

About Weaver Consulting. Founded in 2003, Weaver Consulting has thousands of alumni from hundreds of organizations globally across a multitude of industries, and is a proud partner of the FDA Center of Excellence, Regulatory Affairs Professionals Society, American Society of Quality, Parenteral Drug Association, and other quality/regulatory focused institutions.

Audience. Appropriate for professionals from all industries, particularly those highly regulated. Participants often have backgrounds in quality, engineering, production, risk management, regulatory affairs, R&D, purchasing, project management, etc. To learn more about what our alumni are saying, please review our testimonials.

Course Description

Root Cause Investigation for CAPA is a globally renown methodology for investigating technical performance challenges. Problem solving techniques from Six Sigma, 8D, Kaizen, DMAIC, TQM and others are leveraged to identify technical as well as systemic root causes, corrective and/or preventive actions, and control plans for monitoring/preventing recurrence.

This training is designed to engage the participants the entire time. In addition to the instructor case study, lecture, polls, quizzes, and conversations, participants will apply the methodology during the training collaborating with other participants on two separate real-life case studies.

Participants are provided a training manual, an Investigation Roadmap, and a set of electronic templates that guide them through the methodology, recommend tools, and establish the basis for documentation.

Syllabus

Introduction

  • Overview of the methodology and when to use
  • Discuss common investigation mistakes
  • Define critical terms
  • Introduce participant real life case study

Step 1: Define the Performance Problem

  • Introduce instructor case study
  • Problem statement (investigation focus)
  • Problem description (investigation scope)
  • Workshop
  • Flow chart with key inputs of process(es) within scope of investigation

Step 2: Collect Data

  • Determine data needed (verify and narrow investigation scope)
  • Identify methods for collecting data
  • Consider tools and techniques for analyzing data
  • Workshop

Step 3: Identify Possible Causes

  • Timeline of changes
  • Differences and changes
  • Workshop
  • Risk analysis review
  • Brainstorming techniques (gemba, fishbone, group, individual, etc.)

Step 4: Test Possible Causes

  • Challenge possible causes against data
  • Define "reasonable" assumptions
  • Document testing process results
  • Summarize testing leveraging contradiction matrix
  • Workshop

Step 5: Identify Technical and Systemic Root Cause(s)

  • Verify assumptions
  • Studies/experiments
  • Identify technical root cause(s)
  • Identify systemic root cause(s)

Step 6: Determine Corrective/Preventive Actions

  • Mistake proofing (poke-yoke) vs. variation reduction and optimization techniques
  • Corrective/preventive action(s)
  • Risk mitigation
  • Control plan
  • Acceptance criteria
  • Workshop

Step 7: Verify Corrective/Preventive Actions

  • Implement corrective/preventive actions
  • Evaluate effectiveness (control plan)
  • Determine additional preventive actions
  • Disseminate knowledge gained

Second Participant Real Life Case Study

  • Introduction
  • Workshop developing problem statement, problem description
  • Workshop developing data collection plan
  • Workshop to select and test a possible cause
  • Workshop to develop corrective/preventive action plans for technical and systemic root causes

Finale

  • Compare/contrast this investigation methodology with other approaches
  • Shortcuts
  • Simple investigations
  • Investigation report
  • Return on investment

Cancellation Policy

Sales are final and nontransferable to other events. Replacements can be made at any point before the training begins by notifying Weaver Consulting. In the unlikely event this training is cancelled, refunds will be issued within 30 days of the notice. Weaver Consulting is not responsible for other expenses incurred by registrants.

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Location

Online event

Refund policy

No Refunds

Organizer Weaver Consulting

Organizer of Root Cause Investigation for CAPA

Founded in 2003, Weaver Consulting is solely focused on root cause analysis. Comprised of former Vice Presidents and quality/operations consultants Rob and Tom Weaver, they teach a proven, disciplined methodology to achieve optimal results in as little time as possible while simultaneously ensuring robust documentation meeting the stringent requirements highly regulated industries demand. 

 

Weaver Consulting’s global client base encompasses a multitude of highly regulated industries, including pharmaceutical, medical device, aerospace & defense, automotive, food & beverage, financial services, semiconductor, and more. They have been featured speaker’s with: American Society of Quality, Regulatory Affairs Professionals Society, FDA Center of Excellence, Food Safety Consortium, Food Safety Tech, Parenteral Drug Association, Sparta Connection (TrackWise), Medical Device & Manufacturing, Center for Professional Advancement, and Medtech. They’ve been published or interviewed with: American Pharmaceutical Review and Medtech Insight (The Gray Sheet).

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