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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
Media Partner
Pharma Utility, a magazine dedicated to news and services in the Indian pharmaceutical industry.
IJDRA is Quarterly Open-access and peer-reviewed Journal circulated electronically and Print since 2013
Course Fees
INR 14,000/- + GST
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