Computerised System Validation Master Class - Online Training Recording

Speakers

Yves Samson

Kereon

Dr Robert Stephenson

Rob Stephenson Consultancy

Frank Behnisch

CSL Behring

Objectives

As a specialist for the validation of computerised systems, this Online Training will provide you with

Suggestions on how current regulatory guidance on computerised systems relating to data integrity, critical thinking and CSA (Computer Software Assurance) can be put into practice
Real-life examples of how validation effort can be scaled according to risk-based approaches
Answers to specific questions, e.g. on source code review or on creating specification documents
The opportunity to bring questions from your own practice up for discussion

Background

The V-model has become a standard worldwide methodology for the validation of computerised systems. Regulatory requirements, as well as industry guidelines, like GAMP® 5, are orientated towards this model. In practice, you as a validation specialist will want to know how to apply this model to current and increasingly complex validation projects.

Target Group

The Master Class is directed at employees from

IT
Production
Engineering
Quality Assurance
Quality Control

Participants should already have gained experience in the validation of computerised systems, and preferably will have also attended a basic CSV Course.

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 – Gain Understanding of Delegate Experience and Background

Case Study: What the Delegates expect

Capturing delegates expectations
Sharing and reducing to key points in groups
Sharing with all delegates and tutors

Current Challenges and Evolution for CSV Activities

What does compliance really mean?
Data Integrity
Securing operation: cybersecurity
Project agility
Cost efficiency vs effective risk management
Applying critical thinking

Roles, Responsibilities and Governance

PQS – Pharmaceutical Quality System according to ICH Q10
Responsibilities
- Operational ownerships
- Supporting roles
QA oversight

Case Study: Governance Benchmark

Polling Exercise plus facilitated discussion
IT and System Governance
CSV Roles and Responsibilities
Role of Quality Unit

Practical Use of Scalability

What do we mean by Scalability?
How does it work in practice?
How can we combine documents successfully?
How much is enough?

Case Studies: Scaleability of Validation Activities

LIMS – Laboratory Information Management System
Laboratory computerised equipment
Process control system: PLC – Programmable Logic Controller

Writing Requirements Documents

Requirements gathering
Writing good requirements
Use of templates / boilerplates
Requirement Quality

Requirements: The Good, the Bad and the Ugly

Good, bad, and could-be-better requirements
Testability
Use of templates / boilerplates
What you should never write

Ideal Content of a CSV SOP

Embedding the CSV SOP into the PQS
Topics to address

Data Integrity and Record Management: A Necessary Long-Term Approach

Regulatory context
Document life cycle
Retention requirements and constraints
Supporting processes
Areas of concern

System Classification – A Record-based Approach

Needs for record-based system classification
Classification criteria
Class A, B, C, D

Design Review – How to Apply Critical Thinking?

CSA – Computer Software Assurance
Scaleable Risk Management
Document Review

Case Study:Design Review Scaleability

Combining Risk Management & Design Review

Bringing Legacy Systems into Compliance

How to approach legacy system remediation
Examples
- Learning management system
- Laboratory Instruments

Interactive Session: Good Validation Practices
Open session in which delegates score their CSV approach against 12 good validation practices

Each good practice introduced
Delegates score themselves
Results consolidated and fed back
Allows delegates to compare their CSV system against best practice and other practitioners

Alternative & Agile Approaches

Alternative software development models
- Unified Process, Scrum
Agility objectives
- Need for flexible engineering methodologies
What Agile engineering is not
- What Agile engineering needs
Practical approaches and recommendation
- Conditions for success

Validating Spreadsheets

Why are spreadsheets high risks?
Design considerations
What is important (risk again)!
How to document spreadsheet validation

Case Studies: Complex Projects

Global projects
- Roles & Responsibilities
- Data-related requirements
Large systems
- Phase-based implementation and deployment
Interface projects
- Roles & Responsibilities
- Testing

Today / Future IT Compliance Challenges

Open Source Software validation
Challenge demands Infrastructure platforms for applications
Global systems validation vs local defence
Paperless recipes based production – ISA 95 / S 88
Cloud Computing – Data Integrity
Validating Artificial Intelligence (AI)
Challenges for data integrity on Lab-Systems

Elaboration of a Data Integrity Programme

Data Integrity Programme: What to do?
- Topics to address
- Action planning
Embedding the Data Integrity Programme into the PQS
Progress Reporting

Code Review

Principles of code review
Regulatory expectations of code review
Carrying out code reviews
Recording and documenting code Reviews

Real Life Qualification / Validation Projects

Real Life Qualification / Validation Projects
Requirements
Constraints
Issues identified
Lessons learned

Recording from 11-13 May 2022

Duration of Recording: Appr. 15 h

This course is part of the GMP Certification Programme "ECA Certified Computer Validation Manager" Learn more

ECA-Member*:	€ 1790,-
Regular Fee*:	€ 1990,-
EU/GMP Inspectorates*:	€ 995,-
APIC Member Discount*:	€ 1890,-

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

Registration

* also payable by credit card

Further dates on-site

4-6 June 2025, Copenhagen, Denmark

Further dates on-site
Not available

Further dates online

Further dates online
Not available

Do you have any questions?

Please contact us:
Tel.: +49 6221 8444-0
E-Mail: info@gmp-compliance.org

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