Validating Excel and Word Applications Documents --ComplianceOnline Medical Device Training (Medical DeviceTraini)

Venue: Online Event

Location: Palo Alto, California, United States

Event Date/Time: Dec 07, 2010 End Date/Time: Dec 07, 2010
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This validation training will discuss FDA impacts and approaches for compliance for use of COTS (commercial off the shelf) office applications software, such as spreadsheets and word processing
Why Should You Attend:

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.


Online Event
2600 E. Bayshore Road
Palo Alto
United States