EPPIC Presents a Panel Discussion on Compliance Oversight for offshore GMP Operations

Date & Time: Thursday, June 3rd, 2010, 5.30 PM - 8.00 PM

Venue: Crowne Plaza Cabana Hotel, 4290 El Camino Real, Palo Alto. CA 94306

Registration:
Members/Students/Postdocs: $20, Non-members: $35 (seating limited to first 100 attendees).
Free for EPPIC Charter Members and EPPIC 2010 sponsors.

Registration closes on June 1st, 5pm.

To register for this event, click here

Scope: During the recent years, Life Science Industry has followed the path laid out by the garment industry, automotive industry and more recently, the IT industry in partnering with offshore companies who are either manufacture a raw material, a critical component or the entire manufacturing operations. Unlike many examples, we are a regulated industry and so our partners need to be compliant to expected regulatory requirements. What are the necessary oversight mechanisms that are being used currently by the firms to monitor and record for compliance. In addition, what is FDA-Field Inspector noticing as trends if any, to be able to clue us on the firm’s regulatory oversight? Please listen and participate with this panel of experts.

Speakers:

Rochelle Young Pharm. D. – Senior Regulatory Operations Officer, US-FDA Alameda Inspectorate Branch
Will present FDA’s findings on how GMP operations compare and contrast with those on US soil.

Maninder Hora Ph.D. – Vice President, , Product Operations & Quality, Facet Biotech
Will present considerations for selecting, sourcing and auditing of overseas GMP operations and compare with US based organizations

Ralph Napolitano Ph.D. – Director, Quality Assurance, Roche
Will present on the management of the relationship between the Sponsor and the contract manufacturers and the use of quality agreements in doing so.

Moderator:

Ruchika Raval – President, Global Biopharmaceutical Regulation

To register for this event, click here