Seminar on Validation and 21 CFR 11 Compliance of Computer Systems: Intermediate to Advanced by FDA at Washington, DC

MessageThis Webinar is over
Date May 26, 2016
Time 11:00 AM EDT
Cost $1295.00
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.
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 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 system
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:
1.       Validation Master Plan
2.       Complete Validation for a System
3.       Excel Spreadsheet Validation
4.       Change Control
5.       SOPs
6.       Test Tools Validation
7.       Project Management for Validation
Who 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
·         Pharmaceuticals
·         Biotech
·         Medical Device
·         Radiological Health
·         Blood Products
·         Companion Animals
·         Food
·         Cosmetics
·         Tobacco
·         Academia
Day One
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 Requirements
Lecture 3:
Detailed Requirements Study
  • Gathering Requirements
  • Entity Relationship Diagram
  • Process Decomposition
  • Risk Assessment for Requirements
  • Exercise on how to create Requirements
Lecture 4:
  • Design Specifications
  • Software Configuration and Build
  • Exercise on how to create Design Specifications
Day Two
Lecture 5:
CSV Detailed Study (Cont'd)
  • Traceability Matrix
  • Verification and Testing
  • Exercise Creating Validation Scripts
  • Exercise Creating Traceability Matrix
Lecture 6:
Other Documents
  • Validation Plan
  • Test Protocols
    • Test Reports
  • Validation Report
  • Validation Registry
Lecture 7:
Special Topics
  • Project Management for CSV
  • Infrastructure for CSV
  • Selecting software for 21 CFR 11 Compliance
  • Test Tools for CS
Lecture 8:
Change Control & Business Continuity
  • Change Control
  • Implementing Business Continuity for CSVx`
Angela Bazigos, CPHIT, CHP, CBRA, Net+, A+, CCNA, MCP
Angela 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
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 MentorHealth
Phone: 1-800-385-1607
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