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

Training Leader

Warford Reaney CEO,Aveta Lifesciences-USA, Inc

Mr. Reaney has over twenty-five years’ experience in building, developing and managing teams to solve complex technical, compliance and business challenges. He has served in Executive and Quality Management for multi-national corporations, biopharma start-ups and founded pharmaceutical enterprises.


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Speakers of 2017

Deepa Rachel

CEO & Founder
SEEK

Dr. Santosh Kumar Narla

Group Head - Europe
Laurus Labs

Suveer Shrivastava

Vice President - Quality
Mylan Laboratories

Dr.Prashant Pandya

GM-Program Management
Reliance Life Sciences Pvt.Ltd.

Arani Chatterjee

Senior Vice President, Clinical Research
Aurobindo Pharma

Dr.Upendra K Jani

VP-Quality Assurance
Hester Biosciences

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

G.Sundar

Director/Consultant
PharmQA Compliance Services




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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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Our Presenting Partner

Bio-Pharma

SEEK is an intellectual evolution from its parent company Manford which was founded in 1993. Manford operates in a niche area called ‘Science of Exceptionality’, which talks about how in any sphere of life, less than 3% of the population influences the way the world directs itself, the way things are conceived and the kind of opportunities that unfold. Manford used this ideology to create their premiere intervention, the ‘Corporate Breakthrough Workshop’. These workshops have demonstrated breakthrough results in the top and bottom line of organizations.

SEEK’s focus is to make sure the rich legacy and contents of Manford (working with 185 organizations over 82 countries) is taken to a wider audience by means of technology.

Event Partners




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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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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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