The IDMA Technical, R&D and QA Sub-committee and Association of Pharmaceutical Analysts (APA) are jointly organizing an intensive full day seminar on ‘e-Record Keeping in Pharma Industry – Myths and Facts’ on July 25, 2003 in Mumbai.

The personnel from laboratory, quality assurance, regulatory departments of the pharma industry and also IT personnel who need to understand the complexity and specific needs of implementation of pharma-specific computerization and management of electronic records in pharma enterprises are expected to benefit from the deliberations.

The concepts to be covered in the seminar includes operating systems, impact of file-based systems, databases relevant to the lab, security, access control, privileges in the context of GMP, GALP etc, validation of networks, hardware and software for Labs, different requirements for COTS and In-house development products – as how auditors look at it.

The seminar would also deal with investment options available for labs to build foundation systems that are robust, compliant, scaleable and upgradeable in the future and regulatory requirements: current status of international regulations relevant to the pharma industry (21CFR Part 11 as a bench-mark), electronic submissions etc, common-sense approach to increasing productivity in pharma – what’s different and unique about scientific data and how one can leverage it. In the seminar, the case studies would share experiences of various companies in India and internationally who have made significant progress in the field.

Experts in the field including Dr Louis Coutinho, Kiran Peshkar, Milind Kaulgud, Ajit Nagral, Dr V G Nayak and Dr Vasireddi are expected to make presentations at the seminar. The seminar co-ordinator is Dr. Louis Coutinho, NuGenesis Technologies, Mumbai.