Computerized Systems Validation (CSV) Course

December 10-12, 2024
(Online, Zoom)

About the event

Join us for an exciting 3-day online Computerized Systems Validation (CSV) course designed to give you the critical skills to ensure data reliability, accuracy, and regulatory compliance in clinical trials. This course is grounded in global standards, including GAMP® 5, GMP Annex 11, and CFR Title 21 Part 11, and is essential for professionals involved in the implementation and validation of computerized systems.

e-Learning Topics

Participants will gain access to our mobile-friendly platform with text-based modules, videos, exercises, and tests. The self-paced content covers the following subjects:

Introduction and Objectives

Start the day with a clear understanding of the course goals
and what you will achieve by the end of the training
Key Terms and Definitions

Learn the fundamental terminology related to computerized systems, validation, and other essential concepts
Regulatory Landscape

Gain insight into the key regulations and guidelines governing computerized systems in clinical trials
System Development Life Cycle (SDLC)

Understand the SDLC, including its phases, models, and deliverables, as well as high-level software development methods
System Risk Assessment

Explore the basics of conducting high-level risk assessments
for computerized systems. COTS
Computerized System Audit Process

Delve into the objectives, scope, and tools required
for effective computerized system audits
Vendor Audits

Learn how to plan, prepare, conduct, and report on vendor audits, including practical examples of audit plans, validation plans, reports
Change Control

Understand the importance of change control in maintaining validated systems
21 CFR Part 11 Compliance/Annex 11

Explore the requirements for electronic records and signatures,
and how to ensure compliance
Principles of Data Integrity

Discuss the critical principles that underpin data integrity
in computerized systems
Common Findings During CSV Audits/Inspections

Review common pitfalls and findings in CSV audits and inspections, and learn how to avoid them
Introduction to Cloud Computing (Bonus)

Get a high-level overview of cloud computing
and its implications for CSV in clinical trials

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Who Should Attend

This course is perfect for Clinical Operation (Clinical Research Associates, Clinical Project Managers, Study Coordinators, Clinical Research Managers) and Quality Assurance (QA managers and auditors) , and anyone involved in clinical trials. You will gain a thorough understanding of how to manage computerized systems validation in clinical research, ensuring data integrity and regulatory compliance.

Course Topics

Core Concepts of CSV

Understand the fundamentals of computerized systems validation, from methodology to compliance best practices
Compliance and Regulatory Standards

Learn how to navigate complex regulatory environments and ensure your systems meet GAMP® 5, Annex 11, and CFR Title 21 Part 11 standards
Vendor Selection and Audits

Gain insight into effective vendor selection and audit processes to ensure systems meet both regulatory and operational expectations
Project Management Approach to CSV

Explore why implementing computerized systems is not just a task but a full project. Oleg Shakhov will dive deep into project management strategies, explaining when to use Waterfall vs Agile approaches, and how to decide based on the product’s maturity
Critical Project Phases

Key stages of CSV include developing URS, FS, TS and understanding how these documents support the system lifecycle and compliance efforts
Risk Management in System Implementation

Learn how to manage risks throughout the system's lifecycle, including vendor audits and ongoing system support, to maintain system performance and compliance
Practical Case Studies

Real-world insights from industry experts on common challenges and best practices during the validation process

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Course Structure

Format

Hybrid (Live sessions + e-Learning modules)
Duration of live sessions:

3 days
Interactive Learning

6 hours of live expert-led sessions, plus self-paced content available 24/7
Access Period

45 days to complete e-Learning modules

Expert Speakers:

James McDermott

MSc, CStat, CDir, FIoD, Executive Chairman and CEO of Achieve Intelligence Ltd, will bring a wealth of knowledge to the course on key topics such as the regulatory landscape of computerised systems in clinical trials. Additionally, James will cover foundational concepts in system risk assessment and the principles of data integrity
Nairoby Guzmán

Senior Clinical Quality Assurance and CSV & Data Integrity Expert, with a focus
on GCP. She will cover CSV audits, compliance, and best practices
Maxim Bunimovich

MD, MRQA, SQA, CEO and Founder of The QARP, GCP expert and independent GCP auditor, sharing his extensive knowledge
in clinical quality assurance and regulatory compliance
Sabrina Dey

MRQA, Expert QA auditor since 2007 ISO 9001:2015 Lead Auditor Specialty in CSV and GCP Training preparation and delivery for both GCP and CSV
Oleg Shakhov

CEO of Optimal Drive, will participate
as a technical expert, providing real-world insights into the implementation and management of computerized systems from his work on over 100 projects in GMP, GLP, GCP, GDP

Live Online Sessions Schedule

Daily from 18:00 to 19:30 CET

December 10th

Nairoby Guzmán

Computerized System Process Audit
Vendor Audit

December 11th

James McDermott

Regulatory Landscape
21 CFR Part 11 Compliance / Annex 11
Principles of Data Integrity
System Risk Assessment

Note: These topics are also covered in the e-Learning modules. The live session will focus on key points, common challenges, and participant Q&A.

December 12th

Maxim Bunimovich & Sabrina Dey

Cloud Computing

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Course Prices

600€ 300€ — Last Call!

Discounts Available:

10% - second participant from the same organization.
15% - third and subsequent participants from the same organization.
Note: Discounts apply for group registrations from a single organization

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Application form