Frank Behnisch, CSL Behring, Germany
Maik Guttzeit, GEA Lyophil, Germany
Yves Samson, Kereon AG, Basel, Switzerland
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 EU-GMP 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
Leveraging Suppliers Expertise: An Overview of Good Practice
- An open session capturing the expectations of the delegates
Performing a Supplier Assessment
- 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
Workshop 1: Selecting a Supplier
- Why Assess the Supplier?
- The Overall Process
- Assessment Topics
- Types of Assessment
- Corrective Actions & Follow Up Audits
Delegates will plan an assessment of a software supplier using GAMP®5 principles:
Identifying Leveraging Opportunities 1:
- 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
- Quality Planning
- Quality Planning
- Assuring Quality
- Quality Controls
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:
Identifying Leveraging Opportunities 2: Leveraging Testing Activities
- Quality Management System
- Establishing Requirements
- Producing Specifications
- Testing and Release
- Support and Maintenance
Workshop 3: Leveraging Supplier Testing
- What must the supplier do
- What must the regulated company do
- Which supplier tests can be accepted
Delegates will consider what steps are required to ensure that the supplier’s testing results can be accepted without the need for re-execution:
Managing Quality within an Outsourced IS/IT Environment
- Test script development
- Test script execution
- Test script review and approval
- Making a Business Case
- Outsourced Supplier Specification and Selection
- Contract Change and Exit