Overview: Short and quick overview of the Part 11 regulation; detailed description of HOW TO prepare internal and external audits schedules to include Part 11 audits; how to prepare for a specific audit that includes Part 11 regulation; execution of the audits; follow up (difference from other quality audits); training requirements; good practices; commonly asked questions; warning letters examples; and what the future holds when it comes to Part 11. Why should you attend: More and more organizations are striving to "go green" and develop "sustainable" organization's strategies, which almost always includes using more and more of the computer technologies. Areas Covered in the SessionShort and quick overview of the Part 11 regulationDetailed description of HOW TO prepare internal and external audits schedules to include Part 11 auditsHow to prepare for a specific audit that includes Part 11 regulationExecution of the auditsFollow up (difference from other quality audits)Training requirements; good practicesCommonly asked questionsWarning letters examplesWhat the future holds when it comes to Part 11Who Will Benefit:Quality ManagersQuality EngineersSmall Business OwnersInternal and External AuditorsManagement RepsFDA InspectorsConsultantsJasmin NUHIC serves a major medical devices OEM as a Sr. Compliance Quality Engineer and 21 CFR Part 11 Subject Matter Expert. GlobalCompliancePanel Phone: 800-447-9407Fax: 302-288-6884