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Understanding Computer System Validation (CSV) Training Course

A comprehensive and practical introduction

This course covers the key concepts of computer systems validation and provides practical guidance on how to comply with the regulations applicable to the pharmaceutical industry. It will include the regulatory requirements, the industry standards and best industry practice based on Good Automated Machine Practice (GAMP®5). It will provide a practical and efficient framework for computerised systems validation and compliance, and gives attendees an appreciation of how these ideas may be applied to their own systems and processes.

28-29 Nov 2022

Need help?  Enrol or reserve

  • Format: Live online
  • CPD: 12 hours for your records
  • Certificate of completion

Overview

Computer Systems Validation (CSV) is a process used to test, validate and formally document that a regulated computer-based system does exactly what it is designed to do in a consistent and accurate manner that is secure, reliable and traceable. The system has to be relied upon to:

  • produce data accurately and consistently
  • create an indelible electronic data trail that is transparent, traceable and tamper-proof
  • store electronic data records in a way that is safe, secure and can stand the test of time

Computerised system validation and compliance is a regulatory requirement. Inadequate or inappropriate validation can lead to serious non-compliance and quality problems. Compliant and validated computer systems are a prerequisite for effective data integrity.

This course covers the key concepts of computer systems validation and provides practical guidance on how to comply with the regulations applicable to the pharmaceutical industry. It will include the regulatory requirements, the industry standards and best industry practice based on Good Automated Machine Practice (GAMP®5).

This course will provide a practical and efficient framework for computerised systems validation and compliance, and gives attendees an appreciation of how these ideas may be applied to their own systems and processes.

 

Benefits of attending

  • Gain a comprehensive overview of computer system validation (CSV)
  • Enhance your understanding of the key terms used in CSV
  • Recognise how Good Practices apply to computerised systems
  • Understand the different approaches which might be employed
  • Learn how to manage the risk associated with data integrity

Who should attend

  • Quality management specialists
  • Pharmaceutical validation professionals
  • Pharmaceutical project managers
  • Computer system engineering specialists

Enrol or reserve

The Understanding Computer System Validation (CSV) course will cover:

Introduction and welcome

Terminology

  • Key terms
  • Common acronyms

Overview of computer system validation (CSV)

  • Introduction to CSV
  • Why is it so important?
  • Regulatory requirements
  • FDA’s 21 CFR Part 11
  • Other regulatory guidelines
  • International regulations (EudraLex Volume 4 — Annex 11,ICHWHO)
  • The GAMP framework

Where to start

  • How to manage electronic data
  • Risk-based approach to CSV
  • Audit readiness
  • Exercise: data integrity

Types of computer system

  • Business system
  • Standalone control systems
  • Equipment control systems
  • Infrastructure

The six elements

  • Hardware
  • Infrastructure
  • Software
  • Data
  • Documentation
  • Records
  • Exercise: creating an infrastructure map

Validation documentation

  • Inventory
  • SOPs and protocols….
  • Records
  • Training
  • Change control

Industry standards

  • cGMP
  • GAMP®5
  • Validation
  • Eudralex
  • CFR
  • PIC/s
  • Exercise: risk management

Q & A

Introduction and recap of Day 1

Practical application

  • A risk-based approach
  • The V model
  • Software
  • Hardware
  • Exercise: putting them together

Validation in phases

  • Concept
  • Project
  • Operation
  • Retirement
  • Exercise: Supplier involvement

Validation planning

  • Risk-based decisions
  • Supplier assessment
  • Activities
  • Deliverables
  • Responsibilities
  • Exercise scaling effort

Protocols and testing

  • Test relationships
  • Structure
  • Requirements
  • Managing change
  • Exercise: summary report

System validation

  • Software validation
  • Installation Qualification
  • Operational Qualification
  • Performance Qualification
  • Exercise: what comprises validation

Data migration

  • Upgrades
  • New systems
  • Planning and testing
  • Automation vs Manual
  • Exercise: the process

Wrap up and Q & A

Enrol or reserve

Paul Palmer

Paul R Palmer is a Director / Pharmaceutical Consultant and a practicing EU / UK Qualified Person. He has over 35 years experience in the pharmaceutical industry in the development, manufacture and supply of medicinal products and medical devices. 

Throughout his career, Paul has intentionally taken on all opportunities as they arose in order to develop a broad range of knowledge with an in-depth detailed understanding of manufacturing, storage, distribution, research, computerised systems, as well as the facilities and services to support each.

People and systems have always been a core focus, how to ensure best use, optimise and enhance efficiency. He has a level of curiosity rarely displayed in people taking on the qualified person role in pharmaceutical manufacturing. Culture, behaviour and psychology are all significant influences on the systems and processes we implement, but are often ignored.

Paul studied psychology as part of his MSc in 1993 and has always enjoyed observing the world around him with a curiosity that is rarely satisfied.

More details

Book Understanding Computer System Validation (CSV) Live online training

NEW higher discounts for multiple bookings - bring your colleagues to make your training budget go further:

  • 30% off the 2nd delegate*
  • 40% off the 3rd delegate*
  • 50% off the 4th delegate*

Please contact us for pricing if you are interested in booking 5 or more delegates

28-29 Nov 2022

Live online

09:30-17:30 UK (London) (UTC+00)
10:30-18:30 Paris (UTC+01)
04:30-12:30 New York (UTC-05)
Course code 12804

  • GBP 1,099 1,299
  • EUR 1,579 1,859
  • USD 1,786 2,098

Until 24 Oct

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Not ready to book yet?

for 7 days, no obligation

* Early booking discounts may not be combined with other discounts or offers. As such, the discounts for 2nd/3rd/4th delegates are based on the full price.

Multiple colleagues? See above for details of our discounts for 2, 3, or 4 delegates. For more, talk to one of our training experts to discuss how to:

Run this course conveniently and cost-effectively in-house for your staff and colleagues

Aleksandra BEER
Training expert

+44 (0)20 7749 4749

inhouse@ipi.academy