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
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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: David Nettleton,
Computer System Validation’s principal, David Nettleton is an industry leader, author, and teacher for 21 CFR Part 11, Annex 11, HIPAA, software validation, and computer system validation. He is involved with the development, purchase, installation, operation and maintenance of computerized systems used in FDA compliant applications. He has completed more than 260 mission critical laboratory, clinical, and manufacturing software implementation projects. His most popular book is Risk Based Software Validation - Ten easy Steps, which provides fill-in-the-blank templates for completing a COTS software validation project.
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To register/enquire, please contact:
www.compliance.world
Call us at this Toll Free number: +1-866-978-0800
