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Computerized System Validation Training

About Training

Training Info

  • Date : 03 March 2021 / 04 March 2021
  • Training Place :Online
  • Category : Computerized System Validation Training
  • Price : 3.500 TL + KDV

Trainings cover the essential principles using a risk based approached to Computer Systems Validation (CSV) and are designed for professionals seeking training in a practical approach in meeting the regulatory requirements, by using a risk based approach, and an understanding of Good Automated Manufacturing Practice (GAMP5), Annex 11 and CFR Part 11.

You will learn which of your systems require validation – and which do not. This includes custom-built applications, commercial off-the-shelf systems, and spreadsheets.

Computerized System Validation training has been designed not only to meet FDA, ICH, and Eudralex expectations for risk-based validation, but also prepares you to implement these practices in your company. 

This training covers the key concepts of a GxP computerized systems validation and compliance, including the key regulatory requirements and industry good practice based on GAMP5. Computerized System Validation is a basic GxP regulatory requirement. Inadequate and inapporppriate validation approaches can lead to serious compliance and quality issues. Compliant and validated computerized systems are a prerequisite for effective data integrity.

This training describes a practical and efficient framework for computerized systems validation, following current industry good practice, and gives attendees an appreciation of how these ideas may be applied to their own systems.

The training covers the following topics:

  • What is Computerized System Validation
  • Which systems should be validated
  • Regulatory expectations and risk-based validation approaches
  • System categorization based on criticality and complexity (Basic-Medium-Complex)
  • GAMP5 categorization and validation life cycle
  • Definition of raw data, metadata and data
  • Electronic data analysis, static and dynamic data definitions
  • Descibe critical software functions
  • Impact on data integrity
  • Data security (Authorization, Permission, backup and data transferi)
  • Audit trail and review process
  • Planning, Specification, Requirements, Test and Acceptance Criteria Phases
  • Supporting activities
  • IQ, OQ, PQ activities

By the end of this course, you will:

  • understand the current regulatory expectations for GxP, 21 CFR Part 11 and EU GMP Annex 11 for computerised systems
  • gain awareness of the current industry good practice based on GAMP®5
  • understand the principles of a computerized system lifecycle approach
  • understand classification of the systems
  • learn how data types are determined in the system
  • leran how validation activities and documentation are designed according to system types
  • understand the impact of Data Integrity on computerized system validation activities
  • learn how to write tests according to computer system assurance approach (CSA)
  • learn how to manage change control system and deviations
  • learn how to ensure the continuity of the validated status of the systems
  • learn what will be the supporting procedures and practices throughout the system life cycle
  • understand periodic reviews and routine controls in computerized systems and how often they will be done
Computerized System Validation Training

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