Programme 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
Case Study: Selecting a Supplier
- What factors to take into account?
- How to focus the assessment?
- How to engage with the supplier?
- How to report and manage the findings?
- Regulatory expectation
Case Study: Quality Planning within a Supplier’s QMS - Developing a Quality Plan that Delivers
- 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?
Case Study: Leveraging Supplier Testing
- 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
Programme Computerised System Validation Master Class
Introduction – Gain Understanding of Delegate Experience and Background
Case Study: 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
Current Challenges and Evolution for CSV Activities
- What does compliance really mean?
- Data Integrity
- Securing operation: cybersecurity
- Project agility
- Cost efficiency vs effective risk management
- Applying critical thinking
Roles, Responsibilities and Governance
- PQS – Pharmaceutical Quality System according to ICH Q10
- Operational ownerships
- Supporting roles
- QA oversight
Case Study: Governance Benchmark
- Polling Exercise plus facilitated discussion
- IT and System Governance
- CSV Roles and Responsibilities
- Role of Quality Unit
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?
Case Studies: Scaleability of Validation Activities
- LIMS – Laboratory Information Management System
- Laboratory computerised equipment
- Process control system: PLC – Programmable
- Logic Controller
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
Requirements: The Good, the Bad and the Ugly
- Good, bad, and could-be-better requirements
- Use of templates / boilerplates
- What you should never write
Ideal Content of a CSV SOP
- Embedding the CSV SOP into the PQS
- Topics to address
Data Integrity and Record Management: A Necessary Long-Term Approach
- Regulatory context
- Document life cycle
- Retention requirements and constraints
- Supporting processes
- Areas of concern
System Classification – A Record-based Approach
- Needs for record-based system classification
- Classification criteria
- Class A, B, C, D
Design Review – How to Apply Critical Thinking?
- CSA – Computer Software Assurance
- Scaleable Risk Management
- Document Review
Case Study:Design Review Scaleability
- Combining Risk Management & Design Review
Bringing Legacy Systems into Compliance
- How to approach legacy system remediation
- Learning management system
- Laboratory Instruments
Interactive Session: Good Validation Practices
Open session in which delegates score their CSV approach 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
Alternative & Agile Approaches
- Alternative software development models
- Agility objectives
- Need for flexible engineering methodologies
- What Agile engineering is not
- What Agile engineering needs
- Practical approaches and recommendation
- Why are spreadsheets high risks?
- Design considerations
- What is important (risk again)!
- How to document spreadsheet validation
Case Studies: Complex Projects
- Global projects
- Roles & Responsibilities
- Data-related requirements
- Large systems
- Phase-based implementation and deployment
- Interface projects
- Roles & Responsibilities
Today / Future IT Compliance Challenges
- Open Source Software validation
- Challenge demands Infrastructure platforms for applications
- Global systems validation vs local defence
- Paperless recipes based production – ISA 95 / S 88
- Cloud Computing – Data Integrity
- Validating Artificial Intelligence (AI)
- Challenges for data integrity on Lab-Systems
Elaboration of a Data Integrity Programme
- Data Integrity Programme: What to do?
- Topics to address
- Action planning
- Embedding the Data Integrity Programme into the PQS
- Progress Reporting
- Principles of code review
- Regulatory expectations of code review
- Carrying out code reviews
- Recording and documenting code Reviews
Real Life Qualification / Validation Projects
- Real Life Qualification / Validation Projects
- Issues identified
- Lessons learned