The Pune based ONCO Life Sciences Pvt Ltd, is planning to conduct its second two-day training seminar on cGMPs, GLPs and US FDA inspection at Mumbai and Hyderabad in the month of July-August 2007 in collaboration with SPI USA, Baltimore USA.

The two day seminar is expected to provide training for fifty delegates from 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, with special focus on approaching the issues on GMP and GLP compliance and the regulatory inspection with US perspective, is conducted in Mumbai and Hyderabad following the success of the first training session conducted in March 2007 at Mumbai, said Ashish Agarwal, Founder and CEO of ONCO Life Sciences. He said that in the second seminar series, the company has also included Hyderabad in its list, as the region has a growing potential in biotechnology industry.

The seminar will conduct training sessions on regulatory agencies - FDA and EMEA, functioning of good laboratory practice services including laboratory organization and function, facilities, design and qualification, laboratory deviations and out of spec. results, testing and laboratory SOPs and audits.

The seminar will also discuss regulatory demands for cGMP in FDA and EMEA, cGMPs documentation including SOPs and batch records and case studies based on the discussed topics. It will also discuss requirements for international cGMPs, recent developments on cGMPs compliance, steps in the inspection process, biotechnology topics covered during an inspection, inspection trends, FDA 483s - enforcement actions, FDA warning letters, consent decree, license revocation, EMEA enforcement actions etc.

The lectures will be delivered by a team of speakers lead by Dr Antonio Moreira, co-director, Centre for Biotechnology Manufacturing, Maryland Biotechnology Institute-USA.