VALIDATION AND PART 11 COMPLIANCE OF COMPUTER SYST 2016 - Conference on Validation and Part 11 Compliance of Computer Systems and Data
View: 228
Website www.globalcompliancepanel.com |
Edit Freely
Category Life science,FDA,Biomedical,compliance
Deadline: May 07, 2016 | Date: May 09, 2016-May 10, 2016
Venue/Country: Copenhagen, Denmark, Denmark
Updated: 2016-04-29 17:58:22 (GMT+9)
Call For Papers - CFP
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 ManagersIndustries:• Pharmaceuticals• Biotech• Medical Device• Radiological Health• Blood Products• Companion Animals• Food• Cosmetics• Tobacco• AcademiaAgenda:Lecture 1:Introduction / Background• Introductions / Participants' Understanding• Participants' Objectives for the Course (Please come prepared to discuss)Lecture 2:Requirements at a High Level• Types of Requirements• Difference between User Requirements & Functional RequirementsLecture 3:Detailed Requirements Study• Gathering Requirements• Entity Relationship Diagram• Process Decomposition• Risk Assessment for Requirements• Exercise on how to create RequirementsLecture 4:Design• Design Specifications• Software Configuration and Build• Exercise on how to create Design SpecificationsDay 2 Schedule:Lecture 5:CSV Detailed Study (Cont'd)• Traceability Matrix• Verification and Testing• Exercise Creating Validation Scripts• Exercise Creating Traceability MatrixLecture 6:Other Documents• Validation Plan• Test Protocolso Test Reports• Validation Report• Validation RegistryLecture 7:Special Topics• Project Management for CSV• Infrastructure for CSV• Selecting software for 21 CFR 11 Compliance• Test Tools for CSVLecture 8:Change Control & Business Continuity• Change Control• Implementing Business Continuity for CSVSpeaker:Angela BazigosCEO, Touchstone Technologies Silicon ValleyAngela 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 Life science industry.Location: Copenhagen, Denmark Date: May 09th & 10th, 2016 and Time: 9:00 AM to 6:00 PMVenue: WILL BE ANNOUNCED SOONPrice:(Without Stay) Price: $1,695.00 (Seminar for One Delegate)Until April 10, Early Bird Price: $1,695.00 from April 11 to May 07, Regular Price: $1,895.00 (With Stay) Includes Price: $2,095.00 (Seminar for One Delegate)Until April 10, Early Bird Price: $2,095.00 from April 11 to May 07, Regular Price: $2,295.00Quick Contact:NetZealous DBA as GlobalCompliancePanel Phone: 1-800-447-9407Fax: 302-288-6884Email: supportglobalcompliancepanel.com Website: http://www.globalcompliancepanel.comRegistration Link - http://bit.ly/validation-and-21-CFR-11-compliance-Denmark
Keywords: Accepted papers list. Acceptance Rate. EI Compendex. Engineering Index. ISTP index. ISI index. Impact Factor.
Disclaimer: ourGlocal is an open academical resource system, which anyone can edit or update. Usually, journal information updated by us, journal managers or others. So the information is old or wrong now. Specially, impact factor is changing every year. Even it was correct when updated, it may have been changed now. So please go to Thomson Reuters to confirm latest value about Journal impact factor.