ABOUT THE CONFERENCE

Data Integrity is a fundamental element of a (Bio) pharmaceutical industry to ensure quality and safety of drugs. It’s a major global concern of health authorities and (Bio) Pharma companies. Although Data Integrity is not a new issue, it has gain alarming attention in last few years due to FDA’s and MHRA’s scrutiny and a number product detention, import alerts, suspension of marketing authorization and warning letter issued to companies found non-compliant. Although Data integrity is a global issue it is a burning topic in Asia- Pacific, specifically China and India. According to Indian ministry, India has the second-largest number of manufacturing facilities outside of the US (523 as of March 2014) registered with the US FDA. Furthermore, India’s drug exports to the US have risen from US$1.25 billion in FY10 to US$3.45 billion in FY14.2.


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TOPICS

10

SPEAKERS

25

SPONSORS

25

LOCATIONS

2

WORKSHOP LEADER

Dr.Siegfried Schmitt, Principal Consultant, joined PAREXEL Consulting in 2007. He provides consulting services to the medical device and pharmaceutical industry on all aspects of regulatory compliance, particularly the design and implementation of Quality Management Systems and Competitive Compliance. He is the PAREXEL practice lead for Quality by Design.
Dr Schmitt’s areas of expertise include all aspects of quality and compliance for systems, processes, facilities and operations for drug substances and drug products, for all types of formulations. He is a seasoned and experienced auditor, providing support to clients pre and post inspections or audits. He has previously held positions in industry as Senior Production Chemist with Roche and global Quality Director with GE Healthcare and as Validation Manager with Raytheon and Senior Lead Consultant with ABB.


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Speakers of 2017

Chandra Shekar

VP Quality
Reliance life science

Sophia Lily

Head Quality, API and Nutrition
Piramal Enterprises Limited

Suveer Shrivastava

Vice President - Quality
Mylan Laboratories

Arun Mendiratta

Associate VP- QC
Aurobindo Pharma

Dr. Ambrish Srivastava

VP:Medical Affairs, Clinical Research and Regulatory
Alkem Labs Ltd

Dr.Prashant Pandya

GM-Program Management
Reliance Life Sciences Pvt.Ltd.

Dr.Arun Bhatt

Consultant
Clinical Research and Development

Dr Ravisekhar Kasibhatta

Sr.VP - Clinical Research
Lupin Limited

Dr.Nimita Limaye

CEO
Nymro Clinical Consulting Services

Dr.Upendra K Jani

VP-Quality Assurance
Hester Biosciences

Yogesh Joshi

Associate VP- QC
Ajanta Pharma

Dr.Mahesh Bhalgat

Executive Director & COO
Sanofi

Kiran Kumar Merusomayajula

Senior Manager, CQA
Aurobindo Pharma

Dr. Jayam Ravi

Global Compliance Head - Clinical & Pharmacovigilance
Dr. Reddy’s Laboratories

Sanjit Ghosh

Works Manager
Shine Pharmaceuticals




Speakers of 2016

Dr. Vineet Bhushan

Vice President
Dean Learning University

Sandeep Kumar Diwaker

General Manager
Symbiotec Pharmalab

Abhijit S. Kulkarni

Head-Strategic Quality-South Asia
GlaxoSmithKline

Mahesh Kulkarni

Vice President-Global Quality
Dr. Reddy's Laboratories

Suryamohan Surampudi

Head - Plant IT
GxP Assurance & Administration

Yateen Shah

GM- Quality Assurance
Johnson & Johnson

Dr. Ranjana Pathak

Global Head, Quality
Cipla

Mukunth Venkatesan

Founder & CEO
Agaram Technologies Pvt. Ltd

Dr.Nishodh Saxena

PhD

Swapan Bandyopadhyay

VP operations & Manufacturing
Biotech Vision Care



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SEE WHAT OUR LAST YEAR SPEAKERS SAYS

Chinmoy Roy

USFDA Expert
Data Integrity & CSV

Dr.Vineet Bhushan

VP, Dean Learning University
Pfizer

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KEY TOPICS

The 2 Day Conference and workshop will be mix of presentations, hands-on practical sessions, interactive workshops, case studies and panel discussions. Participants are encouraged to put forward their questions prior to the conference; these will be answered and discussed anonymously during the workshop.

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SEE WHAT OUR LAST YEAR SPONSOR SAYS

Mukunth Venkatesan

Founder & CEO
Agaram Technologies Pvt.Ltd.

"Very interesting, realistic conference. Lots of in-depth knowledge shared in this conference Happy to have visited at this conference"

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Event Partners




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Learning Objectives

What are the recent regulatory changes?

Understand the current FDA and EU GMP regulations and guidance impacting data integrity from paper records to hybrid and electronic systems.

How is DI validated?

Understand the FDA requirements for data integrity, MHRA Data Integrity guidance March 2015 and WHO guidance from September 2015.

Data governance

Learn what is required for a data governance system from senior management through to staff in laboratories, manufacturing and quality assurance.

Data life cycle

Understand the data life cycle and how it is linked with the business process and where problems can occur for both paper records, hybrid systems and electronic systems.


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