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2-day In-person Seminar

Validation and 21 CFR 11 Compliance of Computer Systems: Intermediate to Advanced


May 9th & 10th, 2016

Time: 9:00 AM to 6:00 PM

Copenhagen, Denmark

Venue: WILL BE ANNOUNCED SOON


Director : Angela Bazigos
  (Without stay)   Price: $1,895.00
(Seminar Fee for One Delegate)

  (With stay)   Includes   Price: $2,295.00
(Seminar Fee for One Delegate)


**Please note the registration will be closed 2 days (48 Hours) prior to the date of the seminar.

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

Industries:

  • Pharmaceuticals
  • Biotech
  • Medical Device
  • Radiological Health
  • Blood Products
  • Companion Animals
  • Food
  • Cosmetics
  • Tobacco
  • Academia

Day 1 Schedule


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


Lecture 4:

Design

  • Design Specifications
  • Software Configuration and Build
  • Exercise on how to create Design Specifications

Day 2 Schedule


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 CSV

Lecture 8:

Change Control & Business Continuity

  • Change Control
  • Implementing Business Continuity for CSV
Seminar Pricing Includes (With stay)
2 Days' Stay
Pick-up and Drop Facility (Nearest Airport)
Breakfast and Lunch
High Tea
Pack of 3 Past Webinars on similar subject
Group participations
Get fabulous discounts by participating in groups of two or more.
No Attendees Discount
1 2 Attendees 10% off
2 3 to 6 Attendees 20% off
3 7 to 10 Attendees 25% off
4 10+ Attendees 30% off

To avail the above group discounts, all the participants should register by making a single payment

Call our representative TODAY on 1800 447 9407 to have your seats confirmed!

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Angela Bazigos

CEO, Touchstone Technologies Silicon Valley

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: Copenhagen, Denmark Hotel: WILL BE ANNOUNCED SOON  

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