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. With the growing importance of the Indian pharmaceutical industry in the global market, the number of foreign regulatory inspections has also increased considerably.

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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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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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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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