Computerised System Validation: Legacy Systems - Online Training Recording
Course No. 22305
Speakers
Dr Robert Stephenson
Rob Stephenson Consultancy
Yves Samson
Kereon
Uwe Mai
Bayer
We offer you a discount of € 600 if you book this training course together with the course "Computerised System Validation: Maintaining Compliance during Operation?". Book both courses directly as a combination here.
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 online Training course 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 online training course is aimed at subject matter experts from:
IT
Quality Assurance
Production / Quality Control
Technology
System Suppliers and Service Providers
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
Query / Discussion - Problems / Expectations
Which systems are affected?
Why have these systems not been adequately qualified?
Retrospective qualification
Legacy Systems regulatory Requirements and Inspections
Old systems, legacy systems and existing non-compliant systems - characteristics and problems
Regulatory considerations
Annex 11 and Annex 15
PIC/S PI 011
GAMP GPG: The Validation of Legacy Systems
Inspection considerations
Legacy Systems: Ensuring Compliance from a QA Perspective
Legacy systems: IT security / virus protection / data protection
On-site infrastructure
System-side IT components
Qualification / validation of legacy IT systems
How to write URS for existing Systems
How to write URS for existing Systems
URS for existing systems: Waste of time or added value?
Why creating URS is easier for existing systems
Beyond the URS: the functional description
Case Studies: Contingency Planning / Support from the Manufacturer
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?
Recording from 25 February 2025 Duration of Recording: 5h
This course is part of the GMP Certification Programme "ECA Certified Computer Validation Manager" Learn more
Testimonials