Validation And 21 CFR Part 11 Compliance of Computer Systems

Feb 27, 18 Validation And 21 CFR Part 11 Compliance of Computer Systems

Validation And 21 CFR Part 11 Compliance of Computer Systems – India Seminar 2012 at Bangalore

Interactive course to cover every area of 21 CFR 11 and how exactly to include 21 CFR 11 requirements in personal computers validation. Includes exercises where in fact the attendees will build all of the deliverables for a pc system using the 21 CFR 11 concepts and requirements. Finally, a great ‘Jeopardy’ quiz will be utilized to check the participants’ knowledge

Agenda:

Launch TO 21 CFR 11> Background of 21 CFR 11> Current Position of 21 CFR 11> 21 CFR 11 Review> 21 CFR 11.10 (a)-(k)> 21 CFR 11.30> 21 CFR 11.50> 21 CFR 11.70> 21 CFR 11.100> 21 CFR 11.200> 21 CFR 11.300> The FDA’s Requirements for 21 CFR 11> FDA’s Add-On Inspections for 21 CFR 1121 CFR 11.10 (A) PERSONAL COMPUTERS VALIDATION DELIVERABLES> Risk Evaluation> Vendor Audit> Validation Program> Requirements Specification> Style Specification21 CFR 11.10 (A) PERSONAL COMPUTERS VALIDATION DELIVERABLES> Set up Qualification (IQ)> Operational Qualification (OQ)> Functionality Qualification (PQ)> Traceability Matrix> Validation Summary Survey> Validation Registry> SOPs> 21 CFR 11 Audit21 CFR 11.10 (A) PERSONAL COMPUTERS VALIDATION DELIVERABLES Training> Create ALL Deliverables for a Laboratory Details Management Program (LIMS)> Jeopardy – TEST THOROUGHLY YOUR Knowledge

Who’ll benefit:> Everybody using computer systems in FDA or regulated conditions> IT manager and personnel> QA managers and employees> Regulatory affairs> Schooling departments> Consultants> Validation specialists> Task Managers> Suppliers of COTS (Industrial Off The Shelf) systems in regulated industries

Angela Bazigos CEO, Touchstone Technology Silicon Valley

Angela Bazigos may be the CEO of Touchstone Technology Silicon Valley, Inc. an FDA Compliance company. She’s almost 30 years knowledge in theLife sciences sector and has requested patents aimed at accelerating Software Compliance. She actually is an associate of the SQA CVIC (Culture of Quality Assurance Pc Validation Initiative Committee), DIA and RAPS and teaches classes on 21 CFR 11, PERSONAL COMPUTERS Validation, Compliance Technique and Project Management. Recently, Ms. Bazigos was chosen to co-writer Computerized Systems In Clinical Analysis / Current Data Quality and Data Integrity Principles with FDA, DIA and Academia

DATE AND VENUE:9th and 10th April, 2012 in BangaloreConference Timings: 9:00 am – 6:00 pm

Contact Details:Event CoordinatorToll free: 1800 425 9409Phone amount: +91 80-3221-3341 / +91 80-3247-3696 /+91 : +91 80-2642-1483Email: customersupport@globalcompliancepanel.comGlobalCompliancePanelNetZealous Providers India Pvt. Ltd.4th Floor, A, Block, Brigade Software Recreation area,Banashankari 2nd stage,