Frank Behnisch, CSL Behring, Germany
Maik Guttzeit, GEA Lyophil, Germany
Yves Samson, Kereon AG, Switzerland
Dr Rob Stephenson, Rob Stephenson Consultancy, UK
As a specialist for the validation of computerised systems, this event will provide you with
- Suggestions on how the current regulatory developments have to be put into practice
- Real-life examples of how the validation efforts can be controlled by means of risk analysis
- Answers to specific questions, like e.g. on source code review or on drawing up design specifications
- The opportunity to bring questions from your own practice up for discussion
The event is interactive and encourages the active participation of all attendees. Lectures alternate with workshops and discussion sessions.
The V model has become a worldwide standard in the validation of computerised systems. Regulatory requirements as well as industry standards, like e.g. GAMP®, are orientated towards this model. In practice, you as a validation specialist will often wonder in how far this model can be applied to your own validation projects.
The Master Class is directed at employees from
- Quality Assurance
- Quality Control
The participants should already have experience in the validation of computerised systems and preferably to have attended the Basic CSV Course.
Introduction – Gain Understanding of Delegate Experience and Background
Roles, Responsibilities and Governance
Writing Requirements Documents
- Activities for Effective Governance
- Process and System Ownership
- The role of Subject Matter Experts
- The role of QA
Practical Use of Scalability
- What goes into a requirements document?
- What are the considerations for systems?
- Characteristics of good and bad requirements documents
- Sources of requirements information
More about Risk Management
- What do we mean by Scalability?
- How does it work in practice?
- How can we combine documents successfully?
- How much is enough?
Design Review – A Critical Process
- 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
Upcoming Challenges in IT
- When to perform a Design Review?
- Who should participate?
- How to document the Review
- How to manage the findings
Interactive Session: Good Validation Practices
- Open source software / Agil
- Global systems
- EBR / MES
- Cloud Computing / Virtualisation
- Infrastructure Qualification / ITIL
Open session in which delegates score their CSV system themselves against 12 good validation practices.
Change Control and Configuration Management
- 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
Interactive Session: Change Control Examples
- Planned/unplanned changes
- 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
Risk Management and Electronic Records
- Why are spreadsheets high risks?
- Design considerations
- What is important (risk again)!
- How to document spreadsheet validation
- 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
Data Integrity – Formulating a Company Strategy
- Principles of code review
- Regulatory expectations of code review
- Carrying out code reviews
- Recording and documenting code reviews
Handover – the Process and Package
- Management accountability
- Incorporation of data governance in the Quality Management System
- Defining appropriate metrics
- Auditing the data integrity processes
- Reviewing progress
- 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
- Subject matter experts
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