Developing a Strategic Approach to FDA Compliance for Computer System Validation
OVERVIEW
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.
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 webinar, 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
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
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
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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