Live Online Training - Computerised System Validation: Introduction to Risk Management AND the GAMP 5 Approach

Live Online Training - Computerised System Validation: Introduction to Risk Management AND the GAMP 5 Approach

Course No 18443

 

Costs

ECA-Member: EUR 2190,--
Non ECA Member: EUR 2390,--
APIC Member Discount: EUR 2290,--

(All prices excl. VAT)

If you have any questions, please contact us:
Tel.: +49 (0)6221 / 84 44 0 E-Mail: info@gmp-compliance.org

Speakers

Frank Behnisch, CSL Behring GmbH
Yves Samson, Kereon
Dr Robert Stephenson, Rob Stephenson Consultancy

Objectives

Computerised System Validation: Introduction to Risk Management
 
Why you should attend this 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 case studies / interactive sessions you can see how the theoretical foundations will apply practicable
     
Computerised System Validation: The GAMP® 5 Approach
 
Why you should attend this 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 case studies / interactive sessions you can see how the theoretical foundations will apply practicable

Background

Computerised System Validation: Introduction to Risk Management
 
Current GMP regulations and guidelines (EU-GMP Guide Annex 11 ‘Computerised Systems’, ICH Q9, GAMP®5, ASTM E2500-13) focus more and more on the topic of risk management. However, the regulations do not offer much concrete advice on how its principles should be translated into practice during the validation and operation of computerised systems. Therefore, it is the aim of this course to provide you with practice-oriented guidance in performing this task.
 
Computerised System Validation: The GAMP® 5 Approach
 
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

Computerised System Validation: Introduction to Risk Management
 
This Live Online Training is directed at employees from Production, Quality Control / Quality Assurance, Engineering, IT who have to deal with risk assessment and risk management in the field of computer validation.
 
Computerised System Validation: The GAMP® 5 Approach
 
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 webinars, we use Cisco WebEx, one of the leading suppliers of online meetings. At https://www.webex.com/test-meeting.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: Introduction to Risk Management
Introduction – What Do You Want From This Day?
  • Capturing delegates expectations
  • Sharing and reducing to key points in groups
  • Sharing with all delegates and tutors
An Introduction to Risk Management (including ICH Q9)
  • Definition of “Quality Risk Management”
  • Principles of Quality Risk Management
  • Application of the principles in validation
  • Methods of assessing and controlling risk
  • Regulatory expectations for risk management
Risk Management the GAMP® 5 Way
  • The importance of Risk-based Decision Making
  • How the GAMP® 5 Risk Management Approach aligns with ICH Q9
  • The 5-Steps you will need to follow described in detail
  • Risk Management throughout the System Lifecycle
  • Short workshop on Risk Identification and Risk Analysis
Risk Assessment the GAMP® 5 Way
  • The simple GAMP® 5 Risk Assessment Method
  • Assessment Scales for computerised systems that work
  • Functional Risk Assessments and Risk Reduction Strategies
  • Using risk to determine Test Rigour
Case Study: Risk Management Applied to a Computerised System
  • Evaluating identified risks
  • Classification of risks into H, M, L
  • Controls to mitigate unacceptable risks
  • Links to the validation plan and protocols
Case Study: Risk Management Applied to a Control System
  • What are the conclusions from the risk assessment?
  • What options do you have to mitigate (reduce) the higher risks?
  • How will the output affect the protocol?
An Introduction to Risk Ranking
  • What is risk ranking
  • How is it carried out
  • How is it documented?
  • A few useful applications
Case Study: Applying Risk Ranking to Determine Periodic Review Priorities
  • How is severity determined?
  • How can scales be created?
  • Ranking the risks
  • Developing a risk-based action plan.
     
Computerised System Validation: The GAMP® 5 Approach
 
Programme 1st Day
 
Introduction – What the participants expect
An open session capturing the expectations of the delegates
 
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
Validation Overview
  • Qualification / Validation Plan
  • Systems Description
  • Specifications
    • URS / FS / CS / DS
  • Verification
    • Design Review / IQ / OQ / PQ
    • FAT / SAT
  • Qualification / Validation Report
  • VMP – Validation Master Plan
    • Inventories
  • Good Documentation Practices for CSV
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?
Case Study: Self Evaluation of Compliance with Regulatory Expectations
 
The GAMP® 5: 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
User Requirements Specifications (URS)
  • Importance of URS
  • URS 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
 
 
Programme 2nd Day
 
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
Deviation Management
  • Deviation management overview
  • What is a deviation?
  • Deviation management process
  • Taking a risk-based approach
Case Study: Managing Deviations
 
 
Programme 3rd  Day
 
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 Control
 
CSV – Specific Aspects: Automation
  • System Overview / Specifications
  • GAMP®5 and risk analysis
  • Findings & consequences
CSV – Specific Aspects: IT/OT-Infrastructure Qualification
  • The qualification lifecycle
  • How to deal with user requirements
  • Qualification documentation
  • Critical issues
  • Qualification summary report
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 we must learn

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