A three-day training seminar on cGMPs, GLPs and US FDA inspection will be conducted by the Pune-based ONCO Life Sciences in collaboration with SPI USA, Baltimore from 19 to 21 March 2007 at Mumbai.

The seminar will focus on approaching the issues on GMP and GLP compliance and the regulatory inspection with US perspective, for targeted audience including the top brass of pharmaceutical industry, R&D heads, business development teams, QC and QA heads, international marketing heads, people in senor and middle management of pharma, biopharma and biotechnology Industry.

The seminar will discuss aspects on GLPs for the biopharma Industry from US perspective including introduction to the FDA, overview of the science of GLP, GLP laboratory organization and function, GLP facilities, design and qualification, GLP documentation, laboratory deviations and out of specification results, testing laboratory SOPs and Audits, according to Ashish Agarwal, Founder and CEO of ONCO Life Sciences.

Various aspects targeting regulated market, including cGMP regulations for the Biotech/Pharma industry from a US perspective including cGMPs and the FDA, CGMP documentation, prevention of contamination, fundamentals and essentials of validation, controls, recent FDA developments, handling US FDA inspections, FDA inspection process, biotechnology topics covered during an inspection, top ten FDA citations, FDA 483s, consent decree, license renovation and in-house and vendor audits will also be discussed in the three day seminar.

The lectures are to be delivered by a team of experts lead by Dr. António Moreira, Co-director, Centre for Biotechnology Manufacturing, Maryland Biotechnology Institute-USA. Dr Moreira, an expert in biochemical engineering, experienced consultant and a long-term academician, with his vast experience in the U S market, is also responsible for the planning and start up of Centre for Biotechnology Manufacturing Maryland Biotechnology Institute, USA.