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.
Dave is a Computer Systems Validation and Compliance expert. He has worked in the IT / Computer Systems arena for almost 30 years, the last 16 years he has provided consultancy, auditing and training to the pharmaceutical/biotech and healthcare industry across the UK, Europe, Asia and the U.S.A. He is a Chartered Engineer with both the MIET and the MInstMC and a member of the GAMP MES SIG. In his current role he is the Owner and Principal Consultant of Clarity Compliance Solutions Ltd.
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.
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.
Founder & CEO
Agaram Technologies Pvt.Ltd.
Understand the current FDA and EU GMP regulations and guidance impacting data integrity from paper records to hybrid and electronic systems.
Understand the FDA requirements for data integrity, MHRA Data Integrity guidance March 2015 and WHO guidance from September 2015.
Learn what is required for a data governance system from senior management through to staff in laboratories, manufacturing and quality assurance.
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.