Computerised System Validation: The GAMP 5 Approach - Live Online Training
27-29 November 2024
Course No. 21047
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
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)
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Testimonials
Seminar Programme as PDF