– Ajaz Hussain, Management Consultant
Poor data integrity practices noted by US FDA & UK’s MHRA at several companies in India
• Remediation poses several challenges. How to understand why?
It has been alleged that “Chalta-Hai” attitude etc., are part of the cause…
• Understanding human behavior is critical. What may be the root cause of noted ‘cluster’ of challenges?
Both US and UK regulators have acknowledged that many companies in India state-of-the art
• Reason for optimism. It is already happening.
Authorities in India have expressed displeasure on the notion of dual standards
• Signal standard will take time. How to move in this direction and create a win-win opportunity?
Please see the complete presentation @ http://www.slideshare.net/a2zpharmsci/data-
integritytime-to-integrate-human-factros
