Validation And 21 Cfr Part 11 Compliance of Computer Systems

Jul 30, 17 Validation And 21 Cfr Part 11 Compliance of Computer Systems

Validation And 21 Cfr Part 11 Compliance of Computer Systems – US Seminar 2012 at San Francisco

Overview: In December 2010 the FDA changed just how it will audits to add 21 CFR 11 add-on inspections. Hardly any is known concerning this, however the FDA has recently issued citations about them. This Webinar will show the most recent on FDA considering (with slides straight from the FDA’s Workplace of Compliance), discuss how these inspections will effect both your organization an the market, and provide help with how your organization can make sure that they have an effective inspection.

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

Areas Covered in the Program:

Day 1, May 3rd, 2012

Lecture 1: Launch to 21 CFR 11Background of 21 CFR 11Current Status of 21 CFR 1121 CFR 11 Overview21 CFR 11.10 (a)-(k)21 CFR 11.3021 CFR 11.5021 CFR 11.7021 CFR 11.10021 CFR 11.20021 CFR 11.300The FDA’s Requirements for 21 CFR 11FDA’s Add-On Inspections for 21 CFR 11Lecture 2: 21 CFR 11.10 (a) PERSONAL COMPUTERS Validation DeliverablesRisk AssessmentVendor AuditValidation PlanRequirements SpecificationDesign SpecificationLecture 3: 21 CFR 11.10 (a) PERSONAL COMPUTERS Validation DeliverablesInstallation Qualification (IQ)Operational Qualification (OQ)Functionality Qualification (PQ)Traceability MatrixValidation Overview ReportValidation RegistrySOPs21 CFR 11 AuditLecture 4: 21 CFR 11.10 (A) PERSONAL COMPUTERS Validation Deliverables ExerciseCreate ALL Deliverables for a Laboratory Details Administration System (LIMS)Jeopardy – TEST THOROUGHLY YOUR Knowledge

Who’ll benefit:Everybody using computer systems in FDA or regulated environmentsIT supervisor and staffQA managers and personnelRegulatory affairsTraining departmentsConsultantsValidation specialistsProject ManagersVendors of COTS (Business Off The Shelf) systems in regulated industriesAnyone coping with electronic information and/or electronic signatures.

Angela Bazigos may be the CEO of Touchstone Technology Silicon Valley, Inc. an FDA Compliance company. She’s almost 30 years knowledge in the Lifesciences 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 & Venue:

May 03rd and could 04th 2012 at SAN FRANCISCO BAY AREA, Marriott Marquis Downtown8 AM PDT to 5 PM PDT

Price: $1,695.00




Phone: 800-425-9409 Fax: 302-288-6884