Live Webinar on Functional System Requirements for Computer Systems Regulated by FDA
OVERVIEW
This
webinar will take you through the System Development Life Cycle (SDLC) approach to Computer System
Validation (CSV), focusing on the
definition, testing, and documentation of functional and other requirements to
ensure the system meets FDA compliance.
This
FDA compliance training will help you understand how the definition of
functional and other system requirements fit into the System Development
Life Cycle (SDLC) approach
to Computer System Validation (CSV). Getting the requirements right, and ensuring
they are comprehensive, is one of the most challenging components of the
process.
WHY
SHOULD YOU ATTEND
You
should attend this webinar to learn about:
- Computer
System Validation (CSV) approach.
- Using
the System Development Life Cycle (SDLC) methodology to support CSV
efforts.
- CSV
and SDLC deliverables that must be documented properly to comply with FDA
requirements.
- A
deeper dive into the Functional Requirements Specification (FRS)
deliverable, a key document to support the CSV effort.
- Policies,
procedures, training, and organizational change management that are all
key aspects of a successful CSV effort and developing detailed and
thorough requirements.
- Industry
best practices related to CSV and the SDLC methodology, as well as for
delivering solid requirements.
- Common
findings of FDA related to CSV during computer system inspection and audit
that can be avoided by following best practices to develop solid
requirements as part of the effort.
AREAS
COVERED
- Requirements
for Computer System Validation (CSV) in compliance with FDA.
- Applying
a strategic approach to CSV for FDA compliance.
- Using
the System Development Life Cycle (SDLC) methodology to support CSV.
- CSV
strategic planning, execution, and documentation.
- Detailed
analysis of the Functional Requirements Specification (FRS), a key
deliverable for the CSV effort.
- Policies
and procedures to support the CSV effort and your requirements.
- Training
and organizational change management best practices to support CSV and
development of detailed and thorough requirements for testing.
- Preparing
your computer system documentation for an FDA inspection.
- Q&A
LEARNING
OBJECTIVES
- We
will provide an overview of FDA’s guidelines as they pertain to computer
system validation of GxP systems used in manufacturing, marketing,
distribution and other operational activities engaged by companies in
FDA-regulated industries.
- We
will describe the System Development Life Cycle (SDLC) methodology and how
to apply it to Computer System Validation (CSV) work.
- We
will review the SDLC deliverables key to a successful CSV effort.
- We
will take a deeper dive into the Functional Requirements Specification
(FRS) process and documentation to support a successful CSV effort.
- This
course will describe the best practices for developing detailed and
thorough FDA system validation requirements, including roles and
responsibilities, and the policies and procedures that should be followed
to ensure compliance.
- We
will provide specific guidance on industry best practices for delivering
solid requirements that will meet FDA compliance.
WHO
WILL BENEFIT
This
webinar will provide valuable assistance to all personnel in:
- Data
“Owners”
- Data
“Stewards”
- Information
Technology Analysts
- Information
Technology Developers and Testers
- QC/QA
Managers and Analysts
- Clinical
Data Managers and Scientists
- Analytical
Chemists
- Compliance
and Audit Managers
- Laboratory
Managers
- Automation
Analysts
- Computer
System Validation Specialists
- GMP
Training Specialists
- Business
Stakeholders/Subject Matter Experts
- Business
System/Application Testers
- Consultants
working in the life sciences industry who are involved in the validation
of computer systems.
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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