Speakers

Frank Behnisch

CSL Behring

Yves Samson

Kereon

Dr Robert Stephenson

Rob Stephenson Consultancy

Note: All times mentioned are CET.

Objectives

Why you should attend this Live Online Training:

You will systematically be introduced to the principles and methods of the validation of computerised systems (according to GAMP®)
You will learn the skills to plan, implement and document effectively validation activities for computerised systems and to assess them with respect to their GxP compliance
In workshops / interactive sessions you can see how the theoretical foundations will apply practicable

Background

Computerised systems are a central factor determining work sequences in the pharmaceutical industry. Their use increases product safety and saves time and costs of manual intervention. This creates the requirement and necessity, however, to validate all computerised systems which can influence the quality of pharmaceutical products.

The basis of the Live Online Training will be the current requirements for the validation of computerised systems like GAMP® and their GxP-oriented application in practice.

Experts from the pharmaceutical industry and from the GAMP® Committee will show you efficient ways to validate your computerised systems.

Target Group

This Live Online Training is directed towards specialists and executives in the pharmaceutical industry entrusted with the planning, implementation and evaluation of the validation of computerised systems.

Technical Requirements

For our Live Online Training Courses and Webinars, we use Cisco WebEx, one of the leading suppliers of online meetings.

At https://www.webex.com/testmeeting.html you can check if your system meets the necessary requirements for the participation at a WebEx meeting and at the same time install the necessary plug-in. Please just enter your name and email address for the test. If the installation is not possible because of your rights for the computer system, please contact your IT department. WebEx is a standard nowadays and the necessary installation is fast and easy.

Programme

Computerised System Validation: The GAMP 5 Approach - Live Online Training

Seminar Programme as PDF

Introduction – What the Participants expect
An open session capturing the expectations of the delegates

Validation Overview

What do we mean by Validation?
Validation and Qualification
Organising and Planning
Good Documentation Practice
Specification & Verification
System Inventory
System Description

Computerised Systems in Practice

Definition of a Computerised System
Scope of CSV (Computerised System Validation)
- Laboratory Equipment
- Automation / Process Control
- Facility Management
- GxP Applications – GCP / GLP / GMP / GDP / GVP
- IT / OT Infrastructure

Regulatory Framework Overview

GxP: Regulated Good Practices
EudraLex
- Relevant Regulatory Framework for CSV Purposes
US GxP Regulations
Industry Standards

Annex 11 “Computerised Systems” to European GMP

General principles
Project phase
Operation
ERES requirements
Annex 11 vs 21 CFR Part 11
How can you implement it?

Workshop: Self Evaluation of Compliance with Regulatory Expectations

The GAMP® 5 2nd Edition: A Risk-Based Approach to Compliant GxP Computerised Systems

Applicability
GAMP® 5 Key Principles
Life Cycle / ASTM E2500-13 / V-Model
Guide Structure
Risk Management according to ICH Q9

Data Integrity Considerations for CSV

What data are relevant?
ALCOA+: Data Integrity criteria
Paper vs hybrid vs electronic systems
Data integrity requirements for CSV projects

Specifying Requirements

Importance of Requirements Specification (RS)
RS Scope and Contents
Roles & Responsibilities
Requirements Good Practices
POLDAT

GAMP® 5 Software Categories

System Structure
Software Categories 1, 3, 4, 5
End User Application
User View vs IT Perspective

Case Study: Software Categorisation According to GAMP® 5

Functional Specifications – Building the Bridge

Importance of URS – FS linking
FS Scope and Contents
Roles & Responsibilities
FS and FRA
FS Good Practices

Design Specification

CS – Configuration Specification
Detailed Specification
- SDS – Software Design Specification
- SMS – Software Module Specification
- HDS – Hardware Design Specification
- NDS – Network Design Specification

Requirement Traceability

Regulatory expectation vs Good Engineering Practice
Vertical Traceability / Horizontal Traceability
How to trace? - Embedded Traceability / Traceability Matrix

Design Review … More Than a Milestone: A Process

GAMP®5 recommendation on ‘Design Review’
Functional & technical design review
Scaleability of the review activities
Design review: a life cycle supporting process
Design review documentation
From ‘Design Review’ to ‘Periodic Evaluation’

Validation Planning

CSV: A Life cycle approach embedded into the QMS
Validation Master Plan
Qualification & Validation on Project / System Level
- Qualification / Validation Plan
- Supplier Assessment / Supplier Management
- Risk Management
- Documentation
- Verification
- Supporting Processes / System Release

Case Study: Validation Planning

Testing of GxP Systems

Verification vs Validation Terminology
Software testing
Acceptance testing / Factory acceptance test (FAT) / Site acceptance test (SAT)
Qualification testing
- Installation qualification (IQ) / configuration testing
- Operational qualification (OQ) / functional testing
- Performance qualification (PQ) / requirements testing
Good Testing Practice
Management of test environment
Verification of data migration activities
Optimising the test strategy

Test Incident Management

Test incident management overview
What is a test incident?
Test incident Management process
Taking a risk-based approach

Case Study: Test Incidents

Change and Configuration Management During the Project Phase

Regulatory requirements
Configuration management
Change management
Responsibilities
Recommendation
- When to start?
- Areas of concern

Interactive Session: Change Management

CSV – Specific Aspects: Automation

System Overview / Specifications
GAMP®5 and risk analysis
Findings & consequences

Validation Reporting and Handover to Operation

Linking the Validation Plan and Report
Key documents
Validation summary reports
Handover to Operation

CSV: Presentation to Inspectors

Managing the inspection
What inspectors want to see
Warning Letters and 483s
Inspection experiences
Lessons to learn

This course is part of the GMP Certification Programme "ECA Certified Computer Validation Manager" Learn more

ECA-Member*:	€ 2090,-
Non ECA Member*:	€ 2290,-
EU/GMP Inspectorates*:	€ 1145,-
APIC Member Discount*:	€ 2190,-

(All prices excl. VAT). Important notes on sales tax.

Registration

* also payable by credit card

Further dates on-site

7-9 May 2025, Vienna, Austria

Further dates on-site
Not available

Further dates online

Further dates online
Not available

Recording Available

Recording
Not available

Do you have any questions?

Please contact us:
Tel.: +49 6221 8444-0
E-Mail: info@gmp-compliance.org

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