As part of its continuous education program, the All India Drugs Control Officer’s Confederation (ADCOC) and Food and Drugs Control Administration Gazetted Officers Association (FDCAGOA) have jointly arranged a two-day workshop on ‘Improving Inspection and Managerial skills’ from April 6 to 7, 2018 at Forensic Science University, Gandhinagar to upgrade knowledge and skills of drug control officers working in Gujarat Food and Drug Control Administration (FDCA).

Officials from Gujarat and neighbouring states like Chattishgarh, Goa, Mandhya Pradesh and Maharashtra having experience in the field of regulation ranging from six years to 40 years will participate in the workshop. The topics of discussions will cover both technical subjects and soft skill subjects.

The participants will undergo classroom training for two days and subjects of workshop will be data integrity- a paradigm shift in regulators, international inspections - concept and strategies, concept and need for stability, bioavailability and bioequivalence, salient features of the Narcotic Drugs and Psychotropic Substances Act 1985, principle and need of time management, communication skills, stress management, team building and leadership.

This training program is aimed at training officers who have recently joined department and are already working. The subjects are as such that participants can be trained comprehensively on all relevant aspects of regulatory concerns and also help in improving soft skills.

Participating officials include S W Deshpande, director general, AIDCOC, M Dhilipkumar, president, AIDCOC, Ravi Uday Bhaskar, secretary general, AIDCOC, K Rajabhanu, secretary, AIDCOC who will address the audience regarding functioning and activities of the AIDCOC.

J A Patel, assistant commissioner, Gujarat FDCA, Dr. C D Shelat, deputy commissioner, Gujarat FDCA and V R Shah, deputy commissioner, Gujarat FDCA will coordinate workshop under the guidance of Dr. H G Koshia, commissioner, Gujarat FDCA.

Eminent experts from various fields are also invited to deliver their speech on the subjects assigned.

A workshop by US-based consulting firm World Compliance Seminars (WCS) was also conducted at Ahmedabad recently on how to be prepared timely for US FDA inspections and develop quality culture.

The seminar talked about what FDA investigators look for in a pharmaceutical product and API facility and how to be equipped to avoid last minute rush. It dealt with data integrity and role of data integrity in various functions, current FDA expectations, robust quality control (QC) system, among others.