Seminar on Validation and 21 CFR 11 Compliance of Computer Systems: Intermediate to Advanced by FDA
- Start Date:
- Thursday, 26 May, 2016
- End Date:
- Friday, 27 May, 2016 6:00pm
- Pain Management, Internal Medicine, Pulmonary Medicine, Critical Care, Physical Medicine, Sports Medicine, Headache / Migraine, Health & Nutrition
Course "Validation and 21 CFR 11 Compliance of Computer Systems: Intermediate to Advanced" 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 ToolsThe attendees must have attended the Basic Validation & 21 CFR 11 Compliance.
This is a very hands-on class and the attendees will be expected to use templates provided in the class to create the complete package for the validation of a systemThe 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:1. Validation Master Plan2.
Complete Validation for a System3. Excel Spreadsheet Validation4. Change Control5. SOPs6. Test Tools Validation7. Project Management for ValidationWho Should Attend:· VP of IT· Director of IT· Quality Managers· Project Managers (for CSV / IT)· Validation Specialists· Database Administrators· System Administrators· Directors / Senior Directors of Discovery· Directors / Senior Directors of Development· Directors / Senior Directors of Commercialization· Document Managers· Training Managers Industries:· Pharmaceuticals· Biotech· Medical Device· Radiological Health· Blood Products· Companion Animals· Food· Cosmetics· Tobacco· Academia Agenda:Day OneLecture 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 SpecificationsDay TwoLecture 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 CSLecture 8:Change Control & Business ContinuityChange ControlImplementing Business Continuity for CSVx`Speaker:Angela Bazigos, CPHIT, CHP, CBRA, Net+, A+, CCNA, MCPAngela Bazigos, is the CEO of Touchstone Technologies Silicon Valley, Inc. "Your Passport to Compliance".
She has 30 years of experience in the Lifesciences industry spanning Project Management, Quality Assurance and Regulatory Affairs and has a patent aimed at speeding up Software Compliance.Ms Bazigos is a member of the SQA CVIC (Society of Quality Assurance Computer Validation Initiative Committee), ASQ, DIA and RAPS and consults to investment groups on Lifesciences investments as well as Pharma / Biotech / Medical Device companies on compliance matters, including strategy, submissions, quality assurance and remediations following action by the FDA.
She teaches classes on Compliance, 21 CFR 11, Computer Systems Validation, and Project Management both to investor groups and industry.More recently, Ms. Bazigos co-authored Computerized Systems in Clinical Research / Current Data Quality and Data Integrity Concepts with FDA, DIA and Academia. She is on the board for UC Berkeley's Business School for Executive Education in Life Sciences and on the Stanford Who's Who Registry for contributions to the Lifescience industry.
Location: Washington, DC Date:May 26th & 27th, 2016 and Time: 9:00 AM to 6:00 PM Venue:WILL BE ANNOUNCED SOON, Washington, DC Price Details:(Seminar Fee for One Delegate Without stay)-Price: $1,295.00 Until April 20, Early Bird Price: $1,695.00 from April 21 to May 24, Regular Price: $1,895.00 (Seminar Fee for One Delegate-With stay)-Price: $1,695.00 Until April 20, Early Bird Price: $1,695.00 from April 21 to May 24, Regular Price: $1,895.00 Quick Contact:NetZealous DBA as MentorHealthPhone: 1-800-385-1607Email: firstname.lastname@example.orgWebsite: http://www.mentorhealth.com/Registration Link - http://www.mentorhealth.com/control/globalseminars/~product_id=200043SEMINAR Follows us:Twitter: https://twitter.com/MentorHealth1LinkedIn: https://www.linkedin.com/company/mentorhealth
Conference organized by Netzealous -MentorHealth
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