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Training Overview

Objective:

  • Fostering a CAPA culture within the organization at all levels across various functions
  • Enhancing Investigation process effectiveness
  • Developing individual capability for methodological problem solving

Who Will Benefit

  • QA/ QC Department
  • Manufacturing Department
  • Regulatory Department

Learning Outcome:

  • Introduction and Overview of Corrective and Preventive Action (CAPA)
  • CAPA 7 Step Approach as prescribed by ICH Guidelines which are appreciated by regulatory authorities like USFDA & MHRA.
  • Statistical and Project Management tools applicable for CAPA investigation and Analysis

TrainingContent

Introduction and Overview of Corrective and Preventive Action (CAPA) 

  • Common organizational issues addressed by CAPA
  • Definition, history and evolution of CAPA
  • Applications and benefits of CAPA

: Trainer :

Mr. Vijay Dhonde

Mr. Vijay Dhonde, CEO at SSA Business Solutions has over 24 years of industry experience with 15 years of experience in global management consulting in the area of Operational Excellence

  • Identification
    Define the problem (5W2H)
    Sources of Problem
    Evidence of the problem
  • Group Activity
    Case Study Discussion
    Team Brain Storming and presentation on identification and registration of event
    Team Deliberation and faculty feedback
  • Evaluation
    Quantification of Impact
    Severity of consequences
    Classification of Problem
    Counter Measures
    Immediate Communications

Preliminary Investigation 

  • Preliminary Investigation Procedure
  • Check sheet
  • Review of Past History
  • Decision on Proceeding with CAPA
  • Group Activity
    • Case Study Discussion
    • Team Brain Storming and presentation on the preliminary investigation mechanism and the process to be followed for effective investigation along with specific understand of the required soft skill
    • Team Deliberation and faculty feedback

Analysis 

  • Laundry List of Possible Causes
    • Brainstorming
  • Cause and effect diagram
  • Possible causes data collection
    • Pareto chart
    • Histogram
  • Root cause analysis
    • 5-Why Analysis
  • Root Cause Prioritisation
  • Root Cause Validation
    • Scatter Plot
  • Group Activity
    • Case Study Discussion
    • Team Brain Storming and presentation on the root cause identification using fishbone diagram and Why Why Analysis and assessing the importance of getting into the root cause rather than symptoms  

Team Deliberation and faculty feedback

Action plan 

  • Solution Generation
  • Solution Prioritisation
    • Effort-Benefit Matrix
  • Solution FMEA
  • Document or Specification changes
  • Process or system changes

 

Action Implementation 

  • Implementation plan

Follow up 

  • Implementation Review
  • Verification of Effectiveness of CA
  • Plan for Preventive Action
  • Sustenance Measures
    • Control chart

Certification Criteria / IACET CEU’s CEU Requirements

To receive the IACET CEU credit for taking this course you must:

  • Complete the entire course with 100% attendance
  • Get a score of 70% in the test conducted at the end of the workshop
  • Complete the course evaluation form at the end of the course

Upon successful completion, you will receive a course certificate showing the CEU earned.

Training Methodology

  • Live Polls/Quiz
  • Recap Session
  • Case Study Discussion
  • Chalk & Talk Training Method
  • Q&A Sessions
  • Certification

 

Course Accreditation

SSA Business Solutions, is an Authorized Provider of Continuing Education Units (CEUs) by the International Association for continuing Education and Training (IACET). Upon successful completion, the participants will receive a course certificate showing the CEUs earned.

For more details on IACET please visit www.iacet.org

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    Course Fees

    INR 14,000/- + GST

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