Computerised System Validation Master Class - Online Training Recording
Course No. 19563A
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
Testimonials