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What is Process Validation Report | 21CFR11 Compliance Checklist 2018

Start Date:
Thursday, 11 January, 2018
End Date:
Friday, 12 January, 2018 6:00pm
Neurology, Pain Management, Hepatology, Endocrinology, Urology, Infectious Disease, Pediatrics, Rheumatology

Course "Validation and 21 CFR Part 11 Compliance of Computer Systems" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion. Overview: Computer Systems Validation (CSV) also known as Software Validation is all-pervasive in the Life Sciences Industry. It is a requirement of all the predicate rules, as well as 21 CFR 11 and Annex 11. However, unless one knows how to implement CSV, it is often very hard to detect the requirement for CSV, and very hard to determine what needs to be done, to meet domestic and / or international regulations or business continuity requirements.

In addition, the FDA has stepped up 21 CFR 11 inspections that include CSV.This course will build on the Validation and 21 CFR 11 Compliance Basic Course, to give hands on experience on executing on the computer systems validation of a system, and to discuss related activities such as Validation Master Plan, Infrastructure Qualification, Project Management for Validation and Validation of Test Tools The Seminar: This hands-on course will provide the attendees with more detailed experience on validation / 21 CFR 11 compliance of a computer system, as well as details for activities associated with computer systems validation as follows:Validation Master PlanComplete Validation for a SystemExcel Spreadsheet ValidationChange ControlSOPsTest Tools ValidationProject Management for Validation Who Should Attend: VP of ITDirector of ITQuality ManagersProject Managers (for CSV / IT)Validation SpecialistsDatabase AdministratorsSystem AdministratorsDirectors / Senior Directors of DiscoveryDirectors / Senior Directors of DevelopmentDirectors / Senior Directors of CommercializationDocument ManagersTraining Managers Industries: PharmaceuticalsBiotechMedical DeviceRadiological HealthBlood ProductsCompanion AnimalsFoodCosmeticsTobaccoAcademia Agenda: Day 1 Schedule Lecture 1:Introduction / BackgroundIntroductions / Participants' UnderstandingParticipants' Objectives for the Course (Please come prepared to discuss)Lecture 2:Requirements at a High LevelTypes of RequirementsDifference between User Requirements & Functional RequirementsLecture 3:Detailed Requirements StudyGathering RequirementsEntity Relationship DiagramProcess DecompositionRisk Assessment for RequirementsExercise on how to create RequirementsLecture 4:DesignDesign SpecificationsSoftware Configuration and BuildExercise on how to create Design Specifications Day 2 Schedule Lecture 5:CSV Detailed Study (Cont'd)Traceability MatrixVerification and TestingExercise Creating Validation ScriptsExercise Creating Traceability MatrixLecture 6:Other DocumentsValidation PlanTest ProtocolsTest ReportsValidation ReportValidation RegistryLecture 7:Special TopicsProject Management for CSVInfrastructure for CSVSelecting software for 21 CFR 11 ComplianceTest Tools for CSVLecture 8:Change Control & Business ContinuityChange ControlImplementing Business Continuity for CSV Speaker:Angela BazigosCEO, Touchstone Technologies Silicon Valley Angela Bazigos is the CEO of Touchstone Technologies Inc.

She has 40 years of experience in the Life Sciences & Healthcare Industries. Experience combines Quality Assurance, Regulatory Compliance, Information Technology, Project Management, Clinical Lab Science, Microbiology, Food Safety and Turnarounds. Past employers / clients include Roche, Novartis, Genentech & PriceWaterhouseCoopers, Public Health Service. Positions include Chief Compliance Officer,, QA Director, Director of MIS.

Co-authored & prototyped 21 CFR 11 guidance with FDA. Co-authored Computerized Systems in Clinical Research w/ FDA Patent on speeding up software compliance Recently quoted in Wall Street Journal for using training to bring regulatory compliance to the Boardroom

Comments / collaborates with FDA on new guidance documents. Former President of Pacific Regional Chapter of Society of Quality Assurance. Stanford's Who's Who for LifeSciences: Location: Germany Date: January 11th & 12th, 2018 and Time: 9:00 AM to 6:00 PMVenue: WILL BE ANNOUNCED SOON, Germany Price: Price: $1,695.00 (Seminar Fee for One Delegate)Register now and save $200. (Early Bird)Until December 15, Early Bird Price: $1,695.00 From December 16 to January 07, Regular Price: $1,895.00 Register for 5 attendees Price: $5,085.00 $8,475.00 You Save: $3,390.00 (40%)* Register for 10 attendees Price: $9,322.00 $16,950.00 You Save: $7,628.00 (45%)* Sponsorship Program benefits for "Quality Assurance Auditing for FDA Regulated Industry" seminarAt this seminar, world-renowned FDA Regulated Industry subject matter experts interact with CXO's of various designations.

Executives who carry vast experience about FDA Regulated Industry and Experts get down to discussing industry-related best practices, regulatory updates, changes in technologies, and much more relating to FDA Regulated Industry. As a sponsor of these seminars, you get the opportunity to have your product and company reach out to C-Level executives in FDA Regulatory-related industries and become known among these elite executives and subject matter experts.

Apart from being seen prominently at these globally held seminars, you also get talked about frequently in our correspondences with our experts and these participants. For More Information- Normal 0 false false false EN-US X-NONE X-NONE /* Style Definitions */ table.MsoNormalTable{mso-style-name:"Table Normal";mso-tstyle-rowband-size:0;mso-tstyle-colband-size:0;mso-style-noshow:yes;mso-style-priority:99;mso-style-parent:"";mso-padding-alt:0in 5.4pt 0in 5.4pt;mso-para-margin-top:0in;mso-para-margin-right:0in;mso-para-margin-bottom:6.0pt;mso-para-margin-left:0in;line-height:110%;mso-pagination:widow-orphan;font-size:10.0pt;font-family:"Calibri",sans-serif;mso-ascii-font-family:Calibri;mso-ascii-theme-font:minor-latin;mso-hansi-font-family:Calibri;mso-hansi-theme-font:minor-latin;}



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Conference organized by NetZealous DBA as GlobalCompliancePanel

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