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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
specific rules. You’ll learn all about how to create and maintain good
FDA-compliant documentation using a strategic approach based on System
Development Life Cycle (SDLC) Methodologies.
The webinar will leave you with the information needed to plan, execute and
document a computer system validation effort that meets FDA compliance 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.
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) Methodologies when
validating computer systems subject to FDA regulatory compliance. 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 integrity to
avoid FDA compliance deficiencies
• Data Archival to
ensure security, integrity and compliance
LEARNING OBJECTIVES
• To understand how to create, revise
and maintain documentation that must meet the FDA compliance standards
• To understand the computer system validation documentation and many
deliverables required to complete the effort
• To understand industry best practices
• 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
SPEAKER
Carolyn
Troiano has more than 30 years of experience in computer system
validation in the pharmaceutical, medical device, animal health and other
FDA-regulated industries. She is currently managing a large, complex data
migration, analytics and reporting program at a major financial institution.
Use Promo Code XMSNY19 and get flat 20% discount on
all purchases.
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