The DIA and ISPE (International Society for Pharmaceutical Engineering) are organising a joint conference on active pharmaceutical ingredients (APIs) which will focus on 'the India advantages'. The two-day event will be held at Novotel Convention Centre, Hyderabad on August 1 and 2, 2013. The theme of the event is 'Building a Sustainable and Regulatory Compliant API Life Cycle'.

Renowned international and national speakers including Albinus D’sa, deputy country director, US FDA-India, Jason D Rodriguez, chemist, US FDA, will take part in the event to highlight the advantages of the Indian API industry.   The programme chair has two experts: Shashank Lulay, consultant QA & RA and Vijay Kshirsagar, consultant, TRAC Consulting and director, ISPE.

The keynote speakers are Govind Rajan Narayanan, managing director, Aurobindo Pharmaceuticals and Kiran Kumar, president, Inogent Laboratories Private Ltd. (A GVK Bio Company).

The topics for discussion will cover real-time release testing for the API, ideal contents of management review meetings for monitoring API performance, continuous process verification for legacy APIs, recent regulatory trends and risk management, QbD for APIs: Challenges and  Opportunities – a Road Map, surviving global regulatory inspections in today’s environment and outsourcing of regulatory starting materials – changing regulatory expectation.

According to the organisers, the learning objectives of the event would be an effort to update themselves on current quality and regulatory issues, increase  competitiveness, understand the potential focus of regulators during their next inspection, interpret the regulatory requirements in building the robust process technologies adhering to QbD, ICH Q11 etc., instill the culture of built-in ‘quality’, reducing the rate of failures, re-calls, additional cost and time on investigations, documentation and CAPA (corrective and preventive action).