Developing a Strategic Approach to FDA Compliance for Computer System Validation
OVERVIEW
You will learn how to take a strategic
approach to validating computer systems that are regulated by FDA in a way that
will be cost effective and efficient. The webinar will go through the
System Development Life Cycle (SDLC) methodology in detail, and we will
demonstrate how the SDLC supports Computer System Validation (CSV).
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.
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| FDA Compliance for Computer System Validation |
WHY
SHOULD YOU ATTEND
An FDA inspection or audit is something to
take very seriously, and it’s important to have all computer systems that are
regulated by FDA fully validated. In this FDA Compliance training, you
will learn how to validate computer systems in compliance with FDA’s guidelines
and also how to maintain them in a validated state. This will provide you
with a level of certainty that you will be able to respond to FDA questions and
provide the documentation necessary to defend your approach and body of work.
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 link design to functional requirements
- 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
 |
| Compliance Training |
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
- 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
- Learn about industry best
practices related to compliance and computer system validation
- Learn about strategies for
reducing the cost and complexity of compliance with FDA regulations
- Understand how the System
Development Life Cycle (SDLC) methodology supports the computer system
validation process
- Learn how to develop the appropriate
computer validation strategy, to ensure a good balance of cost vs. risk,
thus minimizing both
- Understand how to effectively
document the process of computer system validation, and maintain current
information about the various systems in your organization and how they
are maintained in a validated state
- Learn how to gain information
about trends in validation, as industry progresses and new best practices
emerge
- Understand some of the key
“pitfalls” to avoid when applying the SDLC methodology
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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