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