CAPA Excellence Summit by BlueTech Media LLP

Concept Note

In today’s highly regulated and competitive business environment, organizations across pharmaceuticals, biotechnology, manufacturing, and allied industries continue to face challenges related to repeat deviations, ineffective CAPA closures, audit observations, and quality failures. CAPA is no longer just a regulatory requirement; it has become a critical driver of operational excellence, brand protection, and customer trust. CAPA X: Quality Without Errors is a focused industry forum designed to transform the way organizations approach Corrective and Preventive Action, shifting the mindset from compliance-driven documentation to meaningful, measurable, and preventive quality improvement.

The forum will bring together quality leaders, regulators, auditors, and manufacturing experts to share practical insights on CAPA effectiveness, root cause analysis, audit readiness, data-driven decision-making, and digital quality systems. Designed for professionals from Quality Assurance, Quality Control, Quality Systems, Regulatory Affairs, and many more

The event will focus on key highlights such as CAPA effectiveness and closed-loop reviews, Root Cause Analysis (RCA) mastery, preventive versus reactive CAPA approaches, data-driven CAPA metrics and KPIs, CAPA expectations in global audits (FDA, WHO, EMA), digital CAPA and eQMS automation, and building a zero-error quality culture. This forum promises to deliver immense knowledge, practical takeaways, and valuable industry perspectives, and we look forward to welcoming you to this impactful learning and networking experience.

Why to Attend

Practical insights into effective CAPA implementation

Proven approaches to reduce recurrence of quality issues

Clear understanding of what regulators expect in audits

Proven approaches to reduce recurrence of quality issues

Clear understanding of what regulators expect in audits

Proven approaches to reduce recurrence of quality issues

Exposure to digital tools, eQMS, automation, and data-driven CAPA

Networking with senior QA/QC, regulatory, and operations professionals

Exposure to digital tools, eQMS, automation, and data-driven CAPA

Real-world case studies from pharma and manufacturing leaders

Networking with senior QA/QC, regulatory, and operations professionals

Our Esteemed Speakers

Dr. Souvik Nandi

Mr. Digambar Nigade

Senior General Manager Corporate Quality Assurance Themis Medicare Limited

Mr. Digambar Nigade

Vice President, Quality (Injectables),

Amneal

Mr. Manoj Chitnis

Mr. Digambar Nigade

Mr. Manoj Chitnis

Vice President (Corporate Quality Head),

J B Chemical and Pharmaceutical Limited

Mr. Rishi Vyas

Mr. Digambar Nigade

Mr. Manoj Chitnis

Vice President, Quality Cluster - II & III Head

Sun Pharmaceutical Industries Ltd

Dr. Manoj Kumar

Ms. Bhaswati Chatterjee

Vice President & Site Head,

Concord Biotech Limited

Ms. Bhaswati Chatterjee

GM-QC,

Intas Pharmaceutical (Biopharma)

Mr. Pankaj Gupta

Ms. Bhaswati Chatterjee

Mr. Pankaj Gupta

GM QA,

Kodo Lifescience Pvt. Ltd.

Mr. Suresh Kumar

Ms. Bhaswati Chatterjee

Mr. Pankaj Gupta

Vice President and Head Technology Transfer (Manufacturing Science & Technology), Zydus Group

Mr. Sanjeev Kumar

Mr. Karan R Khairnar

Dr. Bhumi Rajyaguru

Vice President & Head – Corporate Quality & Regulatory Affairs

Jubilant Ingrevia Limited

Dr. Bhumi Rajyaguru

Mr. Karan R Khairnar

Dr. Bhumi Rajyaguru

Jt Director

NABL- Quality Council of India

Mr. Karan R Khairnar

Global Technical Consultant Manager, India & APAC, Ecolab LS / PPC

Dr. Bharti Patil

Mr. Karan R Khairnar

Global API Regulatory Expert

ZENTIVA GROUP

Dr. Nirav Parekh

Mr. Sanjeev Mahajan

DGM Quality, API Division

Alembic pharmaceuticals Ltd

Mr. Sanjeev Mahajan

Founder & Director

PCG-Pharma Consulting Group

Mr. Mukesh Mahajan

Mr. Sanjeev Mahajan

Ms. Kinnari D. Vyas

Director (General Manager)

Kashiv Biosciences

Ms. Kinnari D. Vyas

Mr. Naresh Kumar Gaur

Ms. Kinnari D. Vyas

Associate Vice President, Quality Assurance, Kashiv BioSciences (India)

Mr. Naresh Kumar Gaur

Executive Vice President Manufacturing Operations

Stallion Laboratories

Agenda

Panel Discussion 1: Beyond Compliance – Making CAPA Truly Effective

What defines an effective CAPA vs a closed CAPA
Closed-loop CAPA reviews: ensuring problems don’t return
Common CAPA failures seen during audits
Leadership ownership in driving CAPA effectiveness

Panel Discussion 2: Root Cause Analysis Excellence – Fix the Cause, Not the Symptom

Why most RCAs fail and how to avoid superficial root causes
Practical use of RCA tools (5 Whys, Fishbone, Fault Tree)
Linking RCA outcomes to meaningful corrective and preventive actions
Real audit observations related to weak RCA

Panel Discussion 3: Global Audit Readiness – What Regulators Expect from CAPA

CAPA expectations from FDA, WHO, EMA inspections
Top CAPA-related observations in global audits
Defending CAPA effectiveness during inspections
Preparing inspection-ready CAPA documentation

Panel Discussion 4: Precision, Prevention & Quality Without Errors

The role of precision and reliability in preventing quality deviations
How quality labware and accurate measurements support effective CAPA
Building preventive quality systems through robust inputs and processes
Borosil’s commitment to quality, consistency, and zero-error outcomes

Presentations

Topic: Measuring CAPA Effectiveness – Metrics That Matter
Topic: Preventive vs Reactive CAPA – Building a Zero-Error Quality Culture
Topic: Digital CAPA & eQMS – From Manual Tracking to Intelligent Quality Systems

Register Now

Concept Note

Why to Attend

Practical insights into effective CAPA implementation

Proven approaches to reduce recurrence of quality issues

Clear understanding of what regulators expect in audits

Clear understanding of what regulators expect in audits

Proven approaches to reduce recurrence of quality issues

Clear understanding of what regulators expect in audits

Proven approaches to reduce recurrence of quality issues

Proven approaches to reduce recurrence of quality issues

Exposure to digital tools, eQMS, automation, and data-driven CAPA

Exposure to digital tools, eQMS, automation, and data-driven CAPA

Networking with senior QA/QC, regulatory, and operations professionals

Exposure to digital tools, eQMS, automation, and data-driven CAPA

Real-world case studies from pharma and manufacturing leaders

Networking with senior QA/QC, regulatory, and operations professionals

Networking with senior QA/QC, regulatory, and operations professionals

Networking with senior QA/QC, regulatory, and operations professionals

Networking with senior QA/QC, regulatory, and operations professionals

Networking with senior QA/QC, regulatory, and operations professionals

Who Should Attend

Event Highlights

CHIEF GUEST

Dr. Hemant G. Koshia

Advisory Board Members

Dr Mithilesh Trivedi

Dr Mithilesh Trivedi

Dr Mithilesh Trivedi

Ms Jignasa Oza

Dr Mithilesh Trivedi

Dr Mithilesh Trivedi

Ms. Rajni Jha

Dr Mithilesh Trivedi

Ms. Rajni Jha

Our Esteemed Speakers

Dr. Souvik Nandi

Mr. Digambar Nigade

Mr. Digambar Nigade

Mr. Digambar Nigade

Mr. Digambar Nigade

Mr. Digambar Nigade

Mr. Manoj Chitnis

Mr. Digambar Nigade

Mr. Manoj Chitnis

Mr. Rishi Vyas

Mr. Digambar Nigade

Mr. Manoj Chitnis

Dr. Manoj Kumar

Ms. Bhaswati Chatterjee

Ms. Bhaswati Chatterjee

Ms. Bhaswati Chatterjee

Ms. Bhaswati Chatterjee

Ms. Bhaswati Chatterjee

Mr. Pankaj Gupta

Ms. Bhaswati Chatterjee

Mr. Pankaj Gupta

Mr. Suresh Kumar

Ms. Bhaswati Chatterjee

Mr. Pankaj Gupta

Mr. Sanjeev Kumar

Mr. Karan R Khairnar

Dr. Bhumi Rajyaguru

Dr. Bhumi Rajyaguru

Mr. Karan R Khairnar

Dr. Bhumi Rajyaguru

Mr. Karan R Khairnar

Mr. Karan R Khairnar

Mr. Karan R Khairnar

Dr. Bharti Patil

Mr. Karan R Khairnar

Mr. Karan R Khairnar

Dr. Nirav Parekh

Mr. Sanjeev Mahajan

Mr. Sanjeev Mahajan

Mr. Sanjeev Mahajan

Mr. Sanjeev Mahajan

Mr. Sanjeev Mahajan

Mr. Mukesh Mahajan

Mr. Sanjeev Mahajan