The Indian Drug Manufacturers’ Association (IDMA) Karnataka State Board along with the IDMA Quality Management & Technical Subcommittee and IDMA Regulatory Affairs Subcommittee, Mumbai is now organising a workshop on ‘Laboratory Data Integrity’ to be held on September 4, 2015 at Hotel Chancery Pavilion, Bengaluru from 9.30 a.m.
The objective of the workshop is to ensure hands-on information on data integrity along with practical solutions to deal with these issues across the product life cycle from experts in the field. A panel of experts from the pharmaceutical industry, research, academic and regulatory affairs will converge to interact on the various issues faced with regard to laboratory data integrity.
The organisers recommend that the event needs to be attended by personnel from the departments of manufacturing, analytical development laboratory, research and development, quality assurance, quality control and regulatory affairs.
The seminar is designed to cater to all those involved in pharmaceutical industry, biopharmaceutical industry, biotechnology industry, research institutions, API, excipient & intermediate manufacturers, CROs and students.
The opening address is by T. Ravichandran, vice president, IDMA South along with J L Sipahimalani, chairman, IDMA Quality Management and Technical Subcommittee. The workshop will be inaugurated by Karantaka drugs controller Raghurama Bhandary.
The first session on 'Data Integrity: Reality and Resolution' is by S M Mudda, director-global strategy (technical), Micro Labs Ltd followed by presentation on 'Current Challenges in Data Integrity' by Kapil Bhargava, retired deputy drug controller (India), CDSCO .
The technical session will be on 'Chromatography Do’s and Don’ts by G.N Prashanth, senior vice president - corporate quality at Micro Labs Limited, 'Assessment of Laboratory Data Integrity System' by Rajiv Joshi Partner, Fraud Investigation & Dispute Services, Ersnt & Young, 'Integrated Quality Management for Ensuring Data Integrity' by Sekhar Surabhi CEO, Caliber Group of Companies. This will be followed by a panel discussion on 'Data Integrity – The Way Forward' for which the moderator is S M Mudda. The panelists would be J L Sipahimalani, Kapil Bhargav, Rajiv Joshi, G.N Prashanth, Sekhar Surabhi and A G Raghu, head, Santhana Gopala Consultants, Bengaluru.