System Development Life Cycle Approach to Computer System Validation and FDA Compliance
OVERVIEW
This webinar will leave you with the information needed to plan,
execute and document a computer system validation effort that meets FDAcompliance standards. You will learn about 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.
FDA requires that all computer systems used to produce, manage
and report on GxP (GMP, GLC, and GCP) related products be validated and
maintained in accordance with specific 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.
System Development Life Cycle Approach |
WHY SHOULD YOU ATTEND
This FDA Compliance training 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
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
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.
- To understand and avoid potential pitfalls.
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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