Computer System Validation (CSV) for FDA-Regulated Computers
OVERVIEW
FDA
requires that all computer systems used to produce, manage and report on GxP (GMP, GLC, GCP) related products be validated and
maintained in accordance with FDA system validation rules. You’ll learn all
about how to create and maintain good FDA-compliant documentation using a
strategic approach based on the System Development Life Cycle (SDLC) Methodology.
The
webinar will leave you with the information needed for planning, executing and
documenting a computer system validation effort that meets FDA compliance
standards. You will learn about the computer system validation requirements and
what must be done to ensure the system remains in a validated state.
In
addition, you’ll learn about the various computer system validation
deliverables and how to document them through the entire process.
WHY
SHOULD YOU ATTEND
This
webinar will help you understand in detail Computer System
Validation (CSV) and how to apply
the System Development Life Cycle (SDLC) Methodology when validating computer systems subject
to FDA regulations. This is critical in order to develop the appropriate
validation strategy and achieve the thoroughness required to prove that a
system does what it purports to do.
It
also ensures that a system is maintained in a validated state throughout its
entire life cycle, from conception through retirement. We will discuss the
phases within the SDLC, and how these form the basis for any CSV project. The
importance of the sequence of steps will also be covered.
AREAS
COVERED
- Computer
System Validation (CSV) and the System Development Life Cycle (SDLC)
Methodology
- Good
“Variable” Practice (GxP) (Good Manufacturing Practice (GMP), Good
Laboratory Practice (GLP), Good Clinical Practice (GCP))
- Validation
Strategy that will take into account the system risk assessment process
- Functional
Requirements Specification (FRS) to include detailed needs that are described
in a specific and unique way
- System
Design Specification (SDS) that details how the functional requirements
will be delivered
- Test
Planning, including Development of Scenarios, Cases and Scripts
(Installation Qualification, Operational Qualification and Performance
Qualification)
- Requirements
Traceability Matrix (RTM) that connects the requirements, design and test
elements
- System
Acceptance and Release Notification
- System
Retirement steps to close out the life cycle
- Data
Archival to ensure security, integrity and compliance
LEARNING
OBJECTIVES
- To
understand how to create, revise and maintain documentation that is
FDA-regulated.
- To
understand the many deliverables required to complete a computer system
validation effort.
- To
understand industry best practices for Computer System Validation.
- To
understand and avoid potential pitfalls.
WHO
WILL BENEFIT
- Information
Technology Analysts
- QC/QA
Managers
- QC/QA
Analysts
- Clinical
Data Managers
- Clinical
Data Scientists
- Analytical
Chemists
- Compliance
Managers
- Laboratory
Managers
- Automation
Analysts
- Manufacturing
Managers
- Manufacturing
Supervisors
- Supply
Chain Specialists
- Computer
System Validation Specialists
- GMP
Training Specialists
- Business
Stakeholders responsible for computer system validation planning, execution,
reporting, compliance, maintenance and audit
- Consultants
working in the life sciences industry who are involved in computer system
implementation, validation and compliance
- Auditors
engaged in the internal inspection of labeling records and practices
- All
FDA-regulated industries:
- Pharmaceutical
- Biologicals
- Medical
Device
- Tobacco
For more detail please click on this below
link:
Email: support@trainingdoyens.com
Toll Free: +1-888-300-8494
Tel: +1-720-996-1616
Fax: +1-888-909-1882
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