Computerised System Validation: Leveraging Suppliers - Online Training Recording

Costs

*ECA-Member:**	EUR 790,--
*Regular Fee:**	EUR 890,--
*EU/GMP Inspectorates:**	EUR 445,--
*APIC Member Discount:**	EUR 840,--

(All prices excl. VAT). Important notes on sales tax.

Registration

* also payable by credit card

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

Speakers

Stefan Münch, Körber Pharma Consulting, Germany
Yves Samson, Kereon, Switzerland
Dr Robert 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 life cycle
Learn how to work with your supplier in order to build a strong and lasting client-supplier relationship

Background

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 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.

Target Group

This ECA 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 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.

Technical Details

To participate in an on demand training course or webinar, you do not need any software. The recordings are made available via a streaming server. In general, the recording is provided in MP4 format, which any PC (Microsoft Windows, Apple IOS) or tablet can easily display.

Timing and Duration:

When you register for the on demand Training course or webinar you can decide at what date you want to follow the training course online. For a 1-day training course you will have 2 days in which the stream is available (for 2-day training course 3 days and for a 3-day training course 4 days). Within in this timeframe you can start & stop the stream according to your needs.

In time before the scheduled date (your desired date) you will receive an e-mail from us with a link for direct participation as well as your log-in data.

Please be aware: The recording does not include the Q & A sessions.

Training Course Documentation and Certificate:

The presentations will be made available as PDF files via download shortly before the online training course. After the event, you will automatically receive your certificate of participation.

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

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

Supplier Audit – The Supplier’s View

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
Implementation
Monitoring
Contract Change and Exit

Recording from 10 May 2022

Duration of Recording: Appr. 6 h

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