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Workshop Overview

Global Regulatory Agencies & cGMP compliance, always expect that complaints, failures and deviations are handled in a systematic & timely manner. In this process, the impact on the “Product Quality” has to be assessed, and measures have to be taken to remedy such deficiencies and avoid them in the future.

This conference will familiarise you with the regulatory requirements and introduce you to the essentials of failure handling. The emphasis is on the independent handling of Complaints, failures and deviations in your everyday work. In the case of studies, practical strategies from practice are presented to you; in breakout sessions, you work out solutions to failures and deviations typically occurring under different. scenarios.

Course Director

Ranjit Barshikar

CEO - QbD International

(Quality by Design / CGMP Consulting - BioPharma / Pharma) United Nations Adviser- MPP Geneva Editorial Board Member- Journal of Generic Medicines UK.

Amit Guru

Regional Director, Solution Enginnering, APAC,

Sparta Systems, A Honeywell Company

Guest Speakers

Dr. Sanjay Jain

President, Amneal India

Dr. B M Rao

Head - QA for Emerging Markets,
Dr. Reddy's Laboratories

Dr. Umesh Kale

Chief of Quality Services, Strides

Dr Rajiv Desai

Executive Vice President, Corporate Quality, Lupin Ltd

Systematically handle deviations and failures in the manufacture of API / Pharma products to evaluate them in a cGMP-compliant way.

Step by Step implementation of CAPA process to ensure effectiveness as per US FDA / ICH guidelines.

Case studies to demonstrate the evaluation and handling of real-life deviations and failures.

In breakout sessions, you discuss and work out autonomous solution strategies for losses that occurred.

You can discuss failures and deviations from your daily practice with speakers and colleagues.

Quality Culture is necessary at all levels for excellence in CAPA handling as the way forward.

ICH Q9 Quality Risk Management & ICH Q10 Pharmaceutical Quality System requirements.

Importance of systematic documentation of CAPA process.

Quality Assurance & Quality Control Department

Manufacturing Departments

Product / Process Development

Qualification / Validation - who are handling failures and deviations & Investigations CAPA.

R&D Teams

Regulatory Professionals

Key Highlights

 • CDSCO – India • US FDA • EU requirements

• ICH Q10 Pharmaceutical Quality System • ICH Q9 Quality Risk Management • USFDA Quality Systems – Maturity Model

• What is Industry 4.0? • What is Pharma 4.0? • Benefits in CAPA investigations

 •Benefits • CAPA investigation • Complaints Handling • Artificial Intelligence

• Compliance Failures • Recent USFDA / MHRA / EU observations • Challenges

• Identifying Root Causes. • Root Cause • Root Cause Analysis Tools: Brainstorming, • Ishikawa, Pareto Chart, Process Mapping, 5 Whys.

• Stakeholders support • Procedures

• CAPA System • CAPA Steps • Creating Action plan

• Responsibilities • Implementation Steps • Effectiveness Check • Effectiveness Verification

• Non – sterile products • Sterile products • Examples

• 483’s , Warning Letters • US FDA / EU Observations

Several Examples , Case studies

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 .

Delegate Fees

Standard Fees : Rs. 12,000/- + GST
International Fees : $ 299​
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