Computer Validation: Leveraging Suppliers

Computer Validation: Leveraging Suppliers

Copenhagen, Denmark

Course No 15593


Costs

This conference already took place.

If you have any questions, please contact us:
Tel.: +49 (0)6221 / 84 44 0 E-Mail: info@gmp-compliance.org

Speakers

Frank Behnisch, CSL Behring, Germany

Maik Guttzeit, GEA Lyophil, Germany

Dr David Selby, Selby Hope International, UK

Dr Rob Stephenson, Rob Stephenson Consultancy, UK

Objectives

  • 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

Background

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.

Target Group

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.

Programme

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
Identifying Leveraging Opportunities 1:
  • Quality Planning
  • Quality Planning
  • Assuring Quality
  • Quality Controls
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
  • QA
Identifying Leveraging Opportunities 2: Leveraging Testing Activities
  • What must the supplier do
  • What must the regulated company do
  • Which supplier tests can be accepted
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
  • Implementation
  • Monitoring
  • Contract Change and Exit

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