Course:
Computer System Validation for AI/ML and traditional technologies
+17 hours on-demand
+100 Lessons
24/7 for 1 year
Access on desktop, mobile, tablet and TV
English
Progressive discounts (based on the number of licenses purchased)
Pass the test with at least 75% to earn the certificate
About the instructor:
Silvia Martins, an electrical engineer with 20+ years in Life Sciences, specializes in AI and traditional technology validation, data integrity, and e-compliance. As CEO of FIVE Validation, she created GO!FIVE®, an agile digital solution for regulatory compliance with support of a great team.
Description:
This online course offers over 100 on-demand lessons, covering everything from basic to advanced levels at your own pace. Whether new or experienced, you'll learn about CSV, GAMP5® (2nd edition), FDA CSA, AI Europe Act, agile methods, and data migration. The content is designed to address key regulatory agencies, including EMA, FDA, MHRA, and WHO.
Read more:
The course covers the Computer System Validation process, agile methods, digital validation strategies, and AI/ML validation, focusing on data integrity, security, and compliance in regulated industries.
With 24/7 access, you can learn anytime. Each short, focused lesson lasts around 10 minutes, making it easy to fit into your daily routine.
And you'll have 1 year of unlimited access to the course across any device, whether it's a computer, tablet, or mobile. This course is perfect for anyone looking to enhance their current skills, learn how to validate AI/ML or begin a career in validation.
With 24/7 access, you can learn anytime. Each short, focused lesson lasts around 10 minutes, making it easy to fit into your daily routine.
And you'll have 1 year of unlimited access to the course across any device, whether it's a computer, tablet, or mobile. This course is perfect for anyone looking to enhance their current skills, learn how to validate AI/ML or begin a career in validation.
Program:
• Introduction
• Basic Concepts
• Regulations
• Good Automated Manufacturing Practices (GAMP5®)
• Holistic Control Strategy
• Validation Concept and Application
• Industry 4.0 and Pharma 4.0
• Trending Technologies/Artificial Intelligence
Read more:
⦁ Knowledge Management
⦁ Initial Risk Assessment
⦁ Computerized Systems Inventory
⦁ Inventory Scope Suggestion
⦁ IT and OT Infrastructure Qualification
⦁ Validation Master Plan
⦁ Standard Operating Procedures
⦁ Validation Principles
⦁ System Life Cycle
⦁ Artificial Intelligence Life Cycle
⦁ Model Performance Optimization
⦁ Life Cycle of Documents
⦁ Software and Hardware Categorization
⦁ Electronic Record and Electronic Signature (ERES)
⦁ Access Control
⦁ User Authentication and Electronic Signature
⦁ Electronic Record and Audit Trail
⦁ Audit Trail Review
⦁ User Requirement Specification
⦁ Supplier Assessment
⦁ Validation Plan and Quality Plan
⦁ Risk Assessment
⦁ Configuration and Design Specification
⦁ Design Review and Acceptance Testing
⦁ Verification
⦁ Testing phase
⦁ Verification & Validation (V&V)
⦁ FDA CSA (Computer Software Assurance)
⦁ Agile Methods
⦁ Traceability Matrix
⦁ Validation Report
⦁ Business Intelligence (BI) systems
⦁ Artificial Intelligence (AI) Validation
⦁ EU Artificial Intelligence Act
⦁ PAT and Parametric Release
⦁ Electronic Spreadsheets
⦁ Operation and Keeping Validated Status
⦁ Backup and Restore
⦁ Archiving and Retrieval
⦁ Security Management
⦁ System Retirement
⦁ Data Migration
⦁ Responsibilities
⦁ Suppliers Responsibilities
⦁ Challenges of Validation Projects
⦁ Challenges of Validation Projects - Supplier Perspective
⦁ Final.
⦁ Initial Risk Assessment
⦁ Computerized Systems Inventory
⦁ Inventory Scope Suggestion
⦁ IT and OT Infrastructure Qualification
⦁ Validation Master Plan
⦁ Standard Operating Procedures
⦁ Validation Principles
⦁ System Life Cycle
⦁ Artificial Intelligence Life Cycle
⦁ Model Performance Optimization
⦁ Life Cycle of Documents
⦁ Software and Hardware Categorization
⦁ Electronic Record and Electronic Signature (ERES)
⦁ Access Control
⦁ User Authentication and Electronic Signature
⦁ Electronic Record and Audit Trail
⦁ Audit Trail Review
⦁ User Requirement Specification
⦁ Supplier Assessment
⦁ Validation Plan and Quality Plan
⦁ Risk Assessment
⦁ Configuration and Design Specification
⦁ Design Review and Acceptance Testing
⦁ Verification
⦁ Testing phase
⦁ Verification & Validation (V&V)
⦁ FDA CSA (Computer Software Assurance)
⦁ Agile Methods
⦁ Traceability Matrix
⦁ Validation Report
⦁ Business Intelligence (BI) systems
⦁ Artificial Intelligence (AI) Validation
⦁ EU Artificial Intelligence Act
⦁ PAT and Parametric Release
⦁ Electronic Spreadsheets
⦁ Operation and Keeping Validated Status
⦁ Backup and Restore
⦁ Archiving and Retrieval
⦁ Security Management
⦁ System Retirement
⦁ Data Migration
⦁ Responsibilities
⦁ Suppliers Responsibilities
⦁ Challenges of Validation Projects
⦁ Challenges of Validation Projects - Supplier Perspective
⦁ Final.
The Value We Generate
It was a very valuable training for me, especially in the automation part, which I didn't know much about.
Very productive contents.
Very valuable content.
Very didactic and attentive tutor. Congratulations.
I chose FIVE due to the good reputation in the market and due to previous participation in trainings that were very well conducted.
GAMP5® is a guide that has its intellectual rights reserved by ISPE®. Available for purchase at https://ispe.org/.