Stefan Münch, Körber Pharma Consulting
Yves Samson, Kereon
Dr Robert Stephenson, Rob Stephenson Consultancy
- 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 life cycle
- Learn how to work with your supplier in order to build a strong and lasting client-supplier relationship
Recognising the potential savings and flexibility available, regulated companies are increasingly withdrawing from ‘in-house’ developed solutions and looking to their external 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 Live Online Training aims to provide attendees with the knowledge, and opportunities to practice the skills required, to achieve successful partnerships with their IS/IT suppliers and to improve the efficiency and effectiveness of their validation processes.
This ECA Live Online Training 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 Live Online Training 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.
For our webinars, we use Cisco WebEx, one of the leading suppliers of online meetings. At https://www.webex.com/test-meeting.html
you can check if your system meets the necessary requirements for the participation at a WebEx meeting and at the same time install the necessary plug-in. Please just enter your name and email address for the test. If the installation is not possible because of your rights for the computer system, please contact your IT department. WebEx is a standard nowadays and the necessary installation is fast and easy.
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