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
Workshop 1: Selecting a Supplier
Delegates will plan an assessment of a software supplier using GAMP®5 principles:
- What factors to take into account?
- How to focus the assessment?
- How to engage with the supplier?
- How to report and manage the findings?
- The regulatory expectation
Workshop 2: Quality Planning within a Supplier’s QMS - Developing a Quality Plan that Delivers
- Delegates will follow a case study with practical exercises to identify how the Quality Plan can be modified to address weaknesses identified in the Supplier Assessment:
- Quality Management System
- Establishing Requirements
- Producing Specifications
- Testing and Release
- Support and Maintenance
Identifying Leveraging Opportunities
- Define the role of the supplier
- What must the supplier do?
- What must the regulated company do?
Workshop 3: Leveraging Supplier Testing
Delegates will consider what steps are required to ensure that the supplier’s testing results can be accepted without the need for re-execution:
- Test script development
- Test script execution
- Test script review and approval
Managing Quality within an Outsourced IS/IT Environment
- Making a Business Case
- Outsourced Supplier Specification and Selection
- Contract Change and Exit
Introduction – Gain Understanding of Delegate Experience and Background
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
Roles, Responsibilities and Governance
- Activities for Effective Governance
- Process and System Ownership
- The role of Subject Matter Experts
- The role of QA
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
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
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
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?
Workshop 4: Scaleability 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 sub-divided?
- How can risk management be applied?
- What sub-projects are appropriate?
- Who is involved in each?
- What will the validation plan look like?
Making Use of Risk Information
- Generation a process risk register
- Using the risk register to:
- Identify the range of risk-based controls necessary
- for the effective management of the process
- Identify critical tests for qualification or verification
- Help manage change, incidents, the focus for audits etc.
- Identify the residual risks to be managed
- Show embedding of risk management within the Quality Management System
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
Design Review – A Critical Process
- When to perform a Design Review?
- Who should participate?
- How to document the Review
- How to manage the findings
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
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
- Planned/unplanned changes
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
- 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
- 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
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
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?