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Course No 16741

Computer Systems Validation Master Class & Leveraging Suppliers - Save up to EUR 490 by booking both courses

21-24 May 2019, Vienna, Austria

Non-ECA Members: EUR 2.390,--
ECA Members: EUR 2.190,--
EU GMP Inspectorates: EUR 1.440,--
APIC Members (does not include ECA membership): EUR 2.290,--
(All prices excl. VAT)

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


Frank Behnisch, CSL Behring, Germany

Maik Guttzeit, GEA Lyophil, Germany

Yves Samson, Kereon AG, Basel, Switzerland

Dr Rob Stephenson, Rob Stephenson Consultancy, UK


Computer Validation: Leveraging Suppliers

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

Leveraging Suppliers Expertise: An Overview of Good Practice
  • What is current Good Practice?
  • Optimising Supplier involvement
  • Integrating the Supplier’s expertise and deliverables into your validation process
  • How to do more with less
Performing a Supplier Assessment
  • Why Assess the Supplier?
  • The Overall Process
  • Assessment Topics
  • Types of Assessment
  • Corrective Actions & Follow Up Audits
Identifying Leveraging Opportunities 1: Quality Planning
  • Quality Planning
  • Assuring Quality
  • Quality Controls
Identifying Leveraging Opportunities 2: Leveraging Testing Activities
  • What must the supplier do
  • What must the regulated company do
  • Which supplier tests can be accepted
Managing Quality within an Outsourced IS/IT Environment
  • Making a Business Case
  • Outsourced Supplier Specification and Selection
  • Implementation
  • Monitoring
  • Contract Change and Exit
Computer Systems Validation Master Class

Introduction – Gain Understanding of Delegate Experience and Background

Roles, Responsibilities and Governance
  • Activities for Effective Governance
  • Process and System Ownership
  • The role of Subject Matter Experts
  • The role of QA
Writing Requirements Documents
  • What goes into a requirements document?
  • What are the considerations for systems?
  • Characteristics of good and bad requirements documents
  • Sources of requirements information
Practical Use of Scalability
  • What do we mean by Scalability?
  • How does it work in practice?
  • How can we combine documents successfully?
  • How much is enough?
More about Risk Management
  • What is really important in managing risk?
  • How do you set the “threshold of acceptable risk”?
  • The importance of Risk Registers
  • How to document risk management for benefit
Design Review – A Critical Process
  • When to perform a Design Review?
  • Who should participate?
  • How to document the Review
  • How to manage the findings
Upcoming Challenges in IT
  • Open source software / Agil
  • Global systems
  • EBR / MES
  • Cloud Computing / Virtualisation
  • Infrastructure Qualification / ITIL
Interactive Session: Good Validation Practices
Open session in which delegates score their CSV system themselves against 12 good validation practices
  • Each good practice introduced
  • Delegates score themselves
  • Results consolidated and fed back
  • Allows delegates to compare their CSV system against best practice and other Practitioners
Change Control and Configuration Management
  • Responsibilities
  • Planned/unplanned changes
  • Classification
Interactive Session: Change Control Examples
  • Delegates will work on a variety of change management scenarios
  • Evaluating the magnitude and impact of the change
  • Application of the principles of risk management
  • Leveraging supplier and SME (Subject Matter Expert) expertise
  • Minimising the workload whilst maintaining compliance
Validating Spreadsheets
  • Why are spreadsheets high risks?
  • Design considerations
  • What is important (risk again)!
  • How to document spreadsheet validation
Risk Management and Electronic Records
  • A clear definition of electronic records with examples
  • An overview of the principles of risk management applied to the classification of electronic records
  • When is an audit trail needed
  • Do we need to keep chromatographic (and other) raw data?
  • Examples of the application of controls
  • Impact of the approach on validation of e-record systems
Code Review
  • Principles of code review
  • Regulatory expectations of code review
  • Carrying out code reviews
  • Recording and documenting code reviews
Data Integrity – Formulating a Company Strategy
  • Management accountability
  • Incorporation of data governance in the Quality Management System
  • Defining appropriate metrics
  • Auditing the data integrity processes
  • Reviewing progress
Handover – the Process and Package
  • What is the handover process?
  • Who is the system owner?
  • What does the system owner have responsibility for?
  • How can we persuade the system owners to accept responsibility?

Workshop 1: What the Delegates expect

Working in groups delegates derive their requirements from the training event and share them with the tutors
  • Capturing delegates expectations
  • Sharing and reducing to key points in groups
  • Sharing with all delegates and tutors

Workshop 2: Implications for your Organisation

How does the GAMP® 5 approach change the way we carry out and control our validation/verification activities? Who will be impacted by the changes?
What is the role of
  • IT
  • Engineering
  • Subject matter experts
  • QA

Workshop 3: Writing a Requirement Specification

  • A short exercise to create a working URS and a review of the output
  • Delegates will work on a simple requirements scenario
  • Output will be discussed with the tutors
  • The feedback will be combines and fed back to the delegates
  • Lessons learned will be summarised

Workshop 4: Scalability of Validation

Delegates will be asked to work out what is work a scaled approach to a multi-component system to minimise the cost and time required for validation
  • How should the system be subdivided?
  • How can risk management be applied?
  • What sub-projects are appropriate?
  • Who is involved in each??
  • What will the validation plan look like?

Workshop 5: Application of GAMP® Risk Management Methodology to a Computer System

Delegates will work on a different case study using risk management to reduce the validation effort.
  • Assessment of risks
  • Formulation of an approach
  • Impact on the validation effort
  • Feedback on the outcome of the case study

Workshop 6: Design Review

The delegates will be presented with the typical findings from a Design Review and, in a team-based exercise, will develop a set of risk-based corrective actions to address the issues.

Workshop 7: Data Integrity

The delegates will be presented with an audit observation about deficiencies in the management of data. They will be asked to device a programme to improve data integrity governance as part of the response to the regulatory observation.

Case Study – GAMP® 5 approach

A case study will be presented to illustrate how, using the principles in GAMP® 5, the cost of validation was more than halved.
  • The simplification of the validation system
  • The leverage of supplier expertise
  • The use of the risk-based approach
  • The financial and other benefits of the GAMP® 5 approach

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