Conference Description:

Description

This seminar 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.

Course Objective
Discuss the best practices necessary to ensure all systems are validated appropriately
Learn how to develop the appropriate computer validation strategy, to ensure a good balance of cost vs. risk
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
Q&A

Course Outline
Topics covered include:
Computer System Validation (CSV)
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
User Requirements Specification (URS) to include high-level needs in language familiar to the user
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 (IQ)
Operational Qualification (OQ)
Performance Qualification (PQ) (also referred to as User Acceptance Testing (UAT))
Requirements Traceability Matrix (RTM) that connects the requirements, design and test elements
System Acceptance by the user or owner of the system
System Release Notification once it is put into a production environment
System Retirement steps to close out the life cycle
Data Archival to ensure security, integrity and compliance

Target Audience
This webinar will provide valuable assistance to all personnel in:

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
All FDA-regulated industries:
Pharmaceutical
Biologicals
Medical Device
Tobacco
Animal Health

Speaker: Carolyn Troiano,
Carolyn Troiano has more than 30 years of experience in computer system validation in the pharmaceutical, medical device, animal health, tobacco and other FDA-regulated industries. She is currently an independent consultant, advising companies on computer system validation and large-scale IT system implementation projects. During her career, Carolyn worked directly, or on a consulting basis, for many of the larger pharmaceutical companies in the US and Europe.

To register/enquire, please contact:
www.compliance.world
Call us at this Toll Free number: +1-866-978-0800