Introduction to Computerised Systems Validation

Course Aims:

To provide a sound understanding of the concepts and deliverables associated with Computerised Systems Validation as required by the Pharmaceutical, Medical Device and Biotechnology Industries and associated regulatory bodies. Attendees will become familiar with the expected deliverables associated with Computerised System Validation based on GAMP5 guidelines. Regulations associated with CSV will be introduced.

Course Content:

Computerised System Validation (CSV) Fundamentals

What is Computerised System Validation?
Who needs to validate?
Why validate?
Basic Concepts
Determining when to Validate

Regulations, Standards and Guidelines

EU and FDA Regulations and Guidelines associated with Computerised Systems Validation including EU GMP Annex 11, FDA 21 CFR Part 11, EU & US GLP and GMPs i.e. FDA 21CFR 211, 21CFR 820 and 21CFR 58, and ISO13485.

Life Cycle Approach to CSV based on GAMP5

Introduction to the GAMP5 life cycle approach to validation.
Validation Strategies based on Computerised Systems Categorisation

Life Cycle Phases and Deliverables

Project Phase
Operation Phase
Retirement Phase

Key deliverables and content of CSV Documentation i.e.

User Requirements Specification
Supplier Assessment
Validation Plans
Functional Specification
Design Specifications
Validation Test Protocols
Risk Assessment

Quality Risk Management

Risk Management throughout the Life Cycle
Functional Risk Management

Practical

Learners will provided with a case study and asked to recommend a validation strategy.

General Questions and Answers

Training Duration : 1 day

Training Methods: This class-based course uses a combination of slide presentation and other multi-media to introduce key concepts. The course will also involve interactive discussion and practical examples. Each learner will be provided with a set of CSV Word templates.

Training Assessment: Learners will be split into small groups to participate in case studies and activities.

Target Trainee Profile: This course is aimed at personnel in the Pharmaceutical, Medical Device or Biotechnology Industries who are new to Computerised Systems Validation (CSV) and/or GAMP5. Typically personnel will already be working in the areas of Validation, Quality, IT or Implementation of regulated computerised systems . This course is also aimed at companies who are supplying regulated computerised systems to the Life Science sectors.

Public Course Cost : €350 per person includes course documentation, templates, lunch and refreshments

Note: This course can be arranged specifically for your company. Please contact us if we can assist you with any enquiries in regard to the next public course or if you would like us to arrange a course for you.