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Frank Behnisch, CSL Behring, Germany
Maik Guttzeit, GEA Lyophil, Germany
Dr David Selby, Selby Hope International, UK
Dr Rob Stephenson, Rob Stephenson Consultancy, UK
Learn what activities and deliverables you should expect to see from your IS/IT supplier to demonstrate Supplier Good Practice
Learn how to verify your supplier’s capabilities so that there are “no surprises”.
Learn how to plan validation (verification) activities, leveraging the expertise of your supplier
Learn how to minimise duplication of effort between the supplier and your regulated company in order to achieve lean and effective processes throughout the system lifecycle
Learn how to work with your supplier in order to build a strong and lasting client-supplier relationship
Recognising the potential savings available, regulated companies are increasingly withdrawing from ‘in-house’ developed solutions and looking to their external system suppliers to provide them with innovative and compliant products and services which fulfil their operational and business needs.
The recently released Annex 11 on Computerised Systems states that ‘the competence and reliability of a supplier are key factors when selecting a product or service provider’; ‘Leveraging Supplier Involvement’ is also one of the 5 key concepts of the GAMP®5 guidance ‘A Risk-Based Approach to Compliant GxP Computerized Systems’.
This course aims to provide attendees with the knowledge and a chance to practice the skills required to achieve successful partnerships with their IS/IT suppliers in order to improve the efficiency of the validation (verification) process.
This ECA course is directed at employees from Production, Quality Control/Quality Assurance, Engineering and IS/IT, who have to assess, manage or work with computerised system or service providers.
The course will also be of value to representatives from supplier organisations that are working or seeking to work with Regulated Companies in the Life Sciences Sector.
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
An overview of current good practice approaches to getting effective engagement with IT Systems suppliers throughout the full lifecycle of a system; from initial concept, through the project phase and into operation.
Performing a Supplier Assessment
Why Assess the Supplier?
The Overall Process
Types of Assessment
Corrective Actions & Follow Up Audits
Effective supplier assessment is a critical process which ensures that the customer’s requirements will be met and that any potential inadequacies are identified and addressed effectively. This session will look at the assessment process – in particular assessing the supplier’s QMS (Quality Management System).
Identifying Leveraging Opportunities 1: Quality Planning
This session will focus on the development of a Quality Plan which can facilitate the successful development and implementation of a system. Delegates will learn how the findings from the supplier assessment can be used to achieve cost-effective compliance
Identifying Leveraging Opportunities 2 : Leveraging Testing Activities
What must the supplier do
What must the regulated company do
Which Supplier Tests can be accepted
Effectively involving the supplier in system testing activities provides significant opportunities for gaining efficiencies and reducing costs. This session will discuss strategies for success and how to avoid the pitfalls.
Managing Quality within an Outsourced IS/IT Environment
Increasingly IT services and systems are being outsourced. Annex 11 states that internal IT departments ‘should be considered analogous’. This session considers the controls required to ensure that patient safety, product quality and data integrity are not compromised.
Making a Business Case
Outsourced Supplier Specification and Selection
Contract Change and Exit
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
Testing and Release
Support and Maintenance
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
Workshop 4: Developing Service Level Agreements
In this workshop session delegates will get the opportunity to develop a simple Service Level Agreement:
What Services are being provided?
Responsibilities of the Provider?
Service Level Targets?