<iframe src="https://www.googletagmanager.com/ns.html?id=GTM-K634RCTH" height="0" width="0" style="display:none;visibility:hidden">
Skip to content
0
English

ONLINE COURSE

Specialization Program in Computerized Systems Validations

Learn about the main regulatory, technological, and quality requirements of the Life Science industry with more than 45 hours of specialized training. 

What will you learn? 

  • A complete look at managing computer systems, infrastructure, and equipment in GxP-regulated environments.

  • The main regulatory requirements for IT systems in the Life Sciences industry, plus how to set up and maintain an IT quality system following good manufacturing practices.

  • The different steps of IT system validation: from planning and carrying out validation to keeping systems in a validated state and doing regular reviews.

  • Dive into qualifying tech infrastructure and using Cloud Computing solutions in GxP settings, keeping GAMP guide recommendations and key compliance requirements in mind.

  • Apply the principles of data integrity, evaluate IT service providers and solutions, properly manage GMP documentation, and understand the basics of equipment qualification.
ONLINE
45 hours
2.200€
per person
Buy now >
  • Content
  • Target audience
  • Details
  • Content

    Stage 1: GxP Basics

    • Computer Systems in Regulated Industry

    • IT Quality System in a Regulated Environment

    • GMP Documentation Management

    Stage 2: Systems Validation

    • Computer Systems Validation

    • Maintaining the State of Validation

    • Periodic System Review

    Stage 3: Infrastructures

    • Using Cloud Computing in a GxP-regulated Environment

    • Infrastructure Qualification in a GxP Environment, the New GAMP Guide

    Stage 4: Data Integrity and Vendors

    • Data Integrity - Overview

    • Vendor Evaluation in IT Environments

    Stage 5: Equipment Qualification

    • Good Manufacturing Practices (GMP): Equipment Qualification

  • Target audience

    • Professionals who want to specialize or strengthen their knowledge in Computerized Systems Validation.  
    • IT systems validation technicians.  
    • Developers and integrators of IT systems in GxP environments.  
    • Quality assurance professionals involved in validation processes and regulatory compliance.  
    • IT, QA, Compliance, or technical management heads.

  • Details

    Schedule: flexible, you set the pace.

    Accessibility: available 24/7 for 180 calendar days from the purchase date.

    Included material:

    • Module assessment test

    • Training presentation in PDF

    • Diploma / Certificate of attendance (downloadable from the same platform)

     

    Payment by Bank Transfer: if you prefer to purchase this training via bank transfer, send us an email at academy@ambit-iberia.com

    Billing: if you need an invoice in your company's name, enter all the details when purchasing the training, after "complete purchase," and the Ambit Iberia administration team will send it via email after the purchase.

Courses that may interest you

IT quality system in regulated environments

More information

Vendor Evaluation in IT Environments Course

More information

Computer System Validation in GxP Environments

More information

Maintaining Validation Status in IT Systems

More information