Computerised System Validation: Legacy Systems - Live Online Training
Tuesday, 25 February 2025 9 .00 - 17.30 h
Course No. 22051
Speakers
Dr Robert Stephenson
Rob Stephenson Consultancy
Yves Samson
Kereon
Uwe Mai
Bayer
Note: All times mentioned are CET.
Objectives
Systems must be qualified, and processes must be validated. These principles have applied in the pharmaceutical environment for many years. For many reasons, there are always cases in which this procedure cannot be implemented prospectively, or only with difficulty. These include equipment and systems that are purchased second-hand, equipment that has been used for non-GMP purposes, and equipment that has acquired from other companies.
Are such equipment/systems no longer fit for use in the GMP environment, or can they still be appropriately qualified and validated? This live online training offers you solutions on how to deal with this situation and focuses on the following questions:
Can you still operate legacy systems, and if so, to what extent?
What can the auditor expect, and what solutions would be considered acceptable?
How can existing systems be specified retrospectively?
How can compliance be achieved from a QA perspective?
What can be done if important cybersecurity issues can no longer be technically controlled?
Target Group
This live online training is aimed at subject matter experts from:
IT
Quality Assurance
Production / Quality Control
Technology
System Suppliers and Service Providers
Date & Technical Requirements
Date Live Online Training Tuesday, 25 February 2025, 09.00 h – 17.30 h CET
Technical Requirements
We use Webex for our live online training courses and webinars. At www.gmp-compliance.org/training/online-training-technical-information you will find all the information you need to participate in our events and you can check if your system meets the necessary requirements to participate. If the installation of browser extensions is not possible due to your rights in the IT system, please contact your IT department. Webex is a standard nowadays and the necessary installation is fast and easy.
What does risk-based Deployment mean for existing Systems?
Suitability for use
Learning from operational experience
Importance of periodic evaluation and its results
Quality efficiency
Old Systems, Legacy Systems and existing Systems - Data Integrity light?
Brief overview of the ALCOA++ principles
PIC/S PI 041-1: Data integrity
General problems: inadequate knowledge of the pharmaceutical process and data flow, lack of data definitions, non-existent definition of the GxP relevance of the generated data
Examples of problems with legacy systems and possible solutions
Missing audit trail functionality vs. necessity of an operational audit trail
Problems with user administration (no/too few users can be parameterized within the system)
Data management: ring memory, system data on USB sticks/SD cards > how to deal with this?
This course is part of the GMP Certification Programme "ECA Certified Computer Validation Manager" Learn more
Testimonials
Seminar Programme as PDF