San Francisco Professional Events List

A Risk Based Approach To Testing Of Computerized GxP Systems (com) A

Jan 11, 2018 - 08:30 AM - Jan 12, 04:00 PM
DoubleTree by Hilton San Diego Downtown1646 Front St1646 FrontSan Diego, CA 92101United States,

San Diego,
CA ,
ZIP: 92101


This seminar provides attendees with hands-on guidance on the testing of computerized and software systems that impact patient safety, product quality and data integrity. It will identify the testing that should be performed and the associated level of documentation. The areas covered are:

  • How does testing fit into GaMP5 lifecycle
  • Risk based methodology for testing
  • How do I leverage supplier testing
  • What should I test?
  • How much testing is enough?
  • How should I conduct the tests
  • How should I document my testing
  • How do I maintain the testing integrity of my system
  • Testing related 483s and Warning Letters
  • Case Studies

Seminar Fee Includes:
AM-PM Tea/Coffee
Seminar Material
Attendance Certificate
$100 Gift Cert for next seminar


Who will Benefit:

Below titles working in industries like Pharmaceuticals, Biotech, Medical Device, Radiological Health, Blood Products, Companion Animals, Food, Cosmetics, Tobacco and Academia will be benefited by attending this seminar:

  • 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
  • Regulators

Topic Background:

Testing is the science of identifying defects, so that they can be corrected, and of demonstrating that a system meets intended requirements. Testing computerized systems is considered a fundamental verification activity and appropriate testing is a regulatory expectation as described in many regulations e.g. EU GMP Annex 11.

“Evidence of appropriate testing methods and test scenarios should be demonstrated. Particularly system (process) parameter limits, data limits and error handling should be considered”

The regulated company is responsible for demonstrating compliance and fitness for use. Effective testing demonstrates compliance with regulatory requirements and ensures patient safety, product quality and data integrity as a result of controlling identified risks. The assurance that systems perform as intended for their use reduces the overall lifecycle of implementing and operating the system and prevents delays to the use of the system that might have been caused by the need to make corrections to the system.

Conversely, insufficient or inappropriate testing may cause problems later on in the lifecycle and these problems will be more costly, time consuming and troublesome to resolve. Potential consequences include a system that does not meet intended requirements, a costly program of corrections and increased maintenance and support costs.

Additionally, failure to appropriately test functions that have high impact on patient safety, product quality and/ or data integrity, may undermine the compliance and fitness for intended use of the system. Inadequate testing may lead to regulatory citations and possibly further regulatory action, damaging business credibility, reputation and potential for revenue.

The number and types of tests should be based on risk, complexity and novelty of the software. Testing should confirm that system specifications have been met. This may involve multiple stages of review and testing depending on the type of system, the development method applied and the use of computerized system. Regulated companies should be prepared to justify the adequacy of their testing approach.

A science quality management system such as ICH Q9 should be used to determine the appropriate level of verification and documentation. Tests should be designed to demonstrate that all required risk controls are in place. Proposed changes to the system should trigger an impact analysis to determine the extent of any re-verification, including any regression testing required. Alterations to the system should be made only in accordance with a predefined change control procedure. Such change control procedures need to include provision for proposing, approving and / or backing out of the change.



DAY 01(8:30 AM - 4:30 PM)

  • 08.30 AM - 09.00 AM: Registration
  • 09.00 AM: Session Start
  • Lecture 1: Introduction and Background
    • Introductions / Participants’ Understanding / Participants’ Objectives for the Course (Please come prepared to discuss)
    • Introduction to Testing
    • GaMP5 Key Concepts
    • Risk Management Methodology
  • Lecture 2: Leveraging the Suppliers’ Work
    • Supplier Assessment
    • Leveraging Supplier Testing
    • Determining Appropriate Test Evidence
    • What to do if the supplier does not meet testing requirements
  • Lecture 3: Test Planning & Management
    • Types of Testing
    • Test Policies & Level of Testing
    • Non-Linear S/W Development (e.g. Agile)
    • Test Plan or Strategy
    • Test Specifications, Cases & Scripts
    • Testing Environments
  • Lecture 4: Test Execution & System Handover
    • Test Pre-Requisites
    • Manual Test Execution
    • Automated Test Execution
    • Test Results Recording & Reviewing
    • Test Reporting & System Handover

DAY 02(8:30 AM - 4:00 PM)
  • Lecture 5: Operational Phase Testing
    • Change Control
    • Test Environments
    • Change Implementation / Approval / Rollback
  • Lecture 6: Data Migration Testing
    • Data Migration Principles
    • Manual Data Migration
    • Automated Data Migration
    • Data Migration Verification
    • Change Control for Data Migration
  • Lecture 7: Case Studies – Part 1
    • Testing Configurable IT Systems
    • Testing Spreadsheets and End-User Developed Applications
    • Testing of Cloud Applications
    • Testing Analytical Instruments
  • Lecture 8: Case Studies – Part 2
    • Testing of Infrastructure & Interfaces
    • Testing Process Control Systems
    • Testing Packaged Systems
    • Testing Systems Applying Process Analytical Technology
  • Quiz: Jeopardy!!!!
    • Testing GxP Computerized Systems

Speaker Details

Angela Bazigos
CEO, Touchstone Technologies Silicon Valley

Angela Bazigos, is the CEO of Touchstone Technologies Silicon Valley, Inc. "Knowledge is Power". She has 35 years of experience in the Lifesciences industry spanning GLP, GCP, GMP, Medical Devices & 21 CFR 11 and has a patent aimed at speeding up Software Compliance.

Ms. Bazigos is a Past President of PRCSQA, a member of the SQA CVIC, ASQ, DIA and RAPS. She works closely with the FDA on behalf of her clients. She consults to LifeScience Investment Groups as well as to Pharma / Biotech / Medical Device companies on compliance matters, including strategy, submissions, quality assurance and remediations following action by the FDA.

More recently, Ms. Bazigos co-authored Computerized Systems in Clinical Research / Current Data Quality and Data Integrity Concepts with FDA, DIA and Academia. She was on the board for UC Berkeley’s Business School for Executive Education in Life Sciences and is now on the Stanford Who’s Who Registry for contributions to the Lifesciences industry.



Please contact the event manager Marilyn (marilyn.b.turner(at) ) below for: 
- Discounts for multiple participants.
- Require a price quotation.
- Require to pay by wire transfer or PayPal
- Invitation letter for visa applications

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