ICSQA Annual Conference 2018: Good Laboratory Practice – Compliance Matters and Challenges

Natesan Settiagounder PhD, RQAP-GLP, President ICSQA
Satish Murthy V. MSc, RQAP-GLP, Secretary ICSQA
Muktha Bhagavan MSc, RQAP-GLP, Treasurer ICSQA

The annual conference of the Indian Chapter of the Society of Quality Assurance (ICSQA) was held 6-7 September 2018 at Eurofins Advinus Limited, Bengaluru. A total of 100 professionals participated in the conference. The inaugural speech and keynote address were given by Dr. Y. K. Gupta, Chairman of Technical Committee of the Indian National GLP Compliance Monitoring Authority (NGCMA). Participants included QA professionals, scientists, study personnel, business development personnel and project management personnel from various organizations including testing facilities, research institutes, sponsors, independent consultants, academic institutions and more.

The key objectives of the conference were:

  • Education through information exchange and knowledge sharing
  • Bringing together professionals to deliberate on the requirements and challenges of GLP quality systems
  • To promote a high level of regulatory quality and compliance

There were six sessions, as detailed below:

Session 1: Global GLP Regulations

Session 2: Computer System Validation and Data Integrity

Session 3: Test Item Analysis - Requirements & Challenges

Session 4: Sponsor Responsibilities & Human Errors

Session 5: Test Sites & Service Providers

Session 6: SEND & Computerized Systems

Overall, there were fourteen presentations by professionals during the two-day conference.

A separate “Networking Discussion” session was held wherein the participants were divided into five groups to cover the following five topics:

  • Issues of Test Item Characterization
  • Issues of Multi-Site Studies
  • Deviation, Amendment and Note to file
  • Sponsor’s Obligations to GLP Compliance
  • Data Integrity

A representative from each group presented the key points that emerged during the discussion in that group.

Additionally, a "Quiz” was conducted to assess the understanding of the participants on GLP at the end of the sessions. The top three winners were awarded mementos.

A “Panel Discussion” was also held to address a range of general questions relating to GLP compliance matters and challenges.

Overall, the two-day conference went well with lots of appreciation from the participants for the organizers and to Eurofins Advinus for providing support for conducting the program. The feedback expressed by participants was very much encouraging for the organizers.

The photographs taken during the conference can be viewed using the link https://photos.app.goo.gl/GPrhKNupkEfYv7WJ7. A few of these photographs are furnished below: