Computerised System Validation: The GAMP 5 Approach - Online Training Recording
Course No. 21427
Speakers
Frank Behnisch
CSL Behring
Yves Samson
Kereon
Dr Robert Stephenson
Rob Stephenson Consultancy
Objectives
Why you should attend this Online Training Course:
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 case studies / 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 Online Training Course 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 Online Training Course 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
To participate in an on demand training course or webinar, you do not need any software. The recordings are made available via a streaming server. In general, the recording is provided in MP4 format, which any PC (Microsoft Windows, Apple IOS) or tablet can easily Display.
Timing and Duration: When you register for the on demand Training course or webinar you can decide at what date you want to follow the training course online. For a 1-day training course you will have 2 days in which the stream is available (for 2-day training course 3 days and for a 3-day training course 4 days). Within in this timeframe you can start & stop the stream according to your needs. In time before the scheduled date (your desired date) you will receive an e-mail from us with a link for direct participation as well as your log-in data.
Please be aware: The recording does not include the Q & A sessions.
Training Course Documentation and Certificate: The presentations will be made available as PDF files via download shortly before the online training course. After the event, you will automatically receive your certificate of participation.
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)
Testimonials