Brief Understanding of CAPA
- Wednesday
- April
- 08
- 2026
Hitendrakumar Shah Overview:
CAPA stands for Corrective and Preventive Action. It's a systematic process used in industries like manufacturing, healthcare, and pharmaceuticals to identify, address, and prevent problems or non-conformities.
CAPA is a crucial part of a quality management system, helping organizations improve their processes, products, and services by learning from past mistakes and preventing future ones.
Many professionals still confused between Corrective Action and Preventive action. This session will help all to understand in detail with the concept as well as practical approach to implement mistake proof CAPA by following Poka-Yoke Principle.
Why should you Attend:
The learning objectives are firstly understanding and practical implementation of CAPA approach to rectify the non-conformity, and avoid occurrence as well as recurrence of the same.
The benefits are,
- Full compliance to the guideline requirements
- The participants will get the clarity about this basic concepts. Because, many corrective actions are considered as preventive actions.
- Improved compliance level
- Develop the mistake proof CAPA and essential pieces of CAPA
- Develop strategy for CAPA effectiveness and many more
Areas Covered in the Session:
- Brief introduction of the concept,
- Guideline Requirements
- Some FDA Citations
- Understanding of the CAPA terminology
- Corrective Vs Preventive Actions
- Role of QRM for developing essential pieces of CAPA
- CAPA effectiveness
- Understanding Poka-Yoke Concept
- The Poka-Yoke 2 step working process
- Process of mistake proof actions
- Benefits of Poka -Yoke
- Examples- General as well as pharmaceutical
- Q&A
- Vote of Thanks and contact details
Who Will Benefit:
- Quality Assurance
- Quality Control
- Pharmaceutical IT compliance
- Global QA
- corporate QA and QC
- IT Personnel working or related to Pharma IT Support
Speaker Profile
Hitendrakumar Shah is a Quality oriented professional with over 23 years of experience in Quality Assurance, Quality Control, Quality engineering, Quality auditor, pharmaceutical regulations and regulatory audit compliance.
The area of expertise is as per the requirement of USFDA, EUGMP, PICS, MHRA, TGA, TPD, ANVISA, WHO & Schedule-M Guidelines.
The key competencies include, Quality Compliance, Supplier Audit, build systems to encourage compliance with the principles of data integrity, computer system validation, Training, Risk assessment, Facing the audits, preparation and review of audit compliance, Qualification & validation, system development for CAPA effectiveness, stability studies & solving preapproval or post approval queries raised by regulatory agencies etc.
Independently handled - Quality assurance and Quality Control department for more than 13 years.
Audits faced- USFDA (8 times), ANVISA, MHRA, MCC, TGA,IDMA excellence, WHO audit, EU regulatory (9 times) , Yemen MOH, Digemid (Peru), Russian Authority audit etc.
Analytical Background: The analytical background includes, physical, chemical, microbiological testing of raw material, finished product & Stability samples. Handled the chromatographic instruments - HPLC, GC, FTIR, UV Visible spectrophotometer, AAS etc.