MEDICAL DEVICES 2010 - Validating Excel and Word Applications Documents - Medical Devices webinar By ComplianceOnline

Website http://complianceonline.com/ecommerce/control/trainingFocus/~product_id=701810?channel=ourglocal | Edit Freely

Category Medical Devices,conference,event,Webinar

Deadline: December 07, 2010 | Date: December 07, 2010

Venue/Country: Palo Alto, U.S.A

Updated: 2010-12-03 17:52:09 (GMT+9)

Call For Papers - CFP

Both the U.S. FDA and the EU's MDD require companies to be proactive in reducing risk while increasing user benefits. How does this translate to common software applications programs, e.g., MS-Excel and MS-Word, or similar. How can these be verified and validated? Company quality data must be more "science based". What does "science-based" mean? What V&V (verification and validation) planning steps are expected under the CGMPs and other guidance documents for such apps software? How can these consistently be executed? Where does ISO 14971, ICH Q9, and similar risk management systems come in?

This excel and word document validation webinar will evaluate the climate that has resulted in this call for change, and flag areas for heightened compliance in V&V planning. It will focus on eliminating major systemic validation problems. It will assist the attendee to review their existing system in light of current and anticipated changes in regulatory thinking, and in approaches to implementing necessary changes, in a realistic, risk-based approach.

Note: Use This PromoCode( 108530 ) To Get 10% Discount valid till Dec 20th.