DUBLIN–(BUSINESS WIRE)–The “FDA Compliance and Clinical Trial Computer System Validation” training has been added to ResearchAndMarkets.com’s offering.
The FDA governs the computer systems used to collect, analyze, transfer and report data that is in support of human clinical trials required for drug approval. FDA oversight is based on a Predicate Rule, known as “Good Clinical Practices,” or simply, “GCPs.”
Computer systems subject to GCP requirements must be thoroughly and appropriately validated in accordance with FDA’s guidance on computer system validation. This involves a rigorous set of phases and steps to ensure that, in the language of FDA, “a system does what it purports to do.”
The cost of adequately validating a clinical trial computer system can be high and must be weighed against system risk and usage. GAMP 5 system classification guidelines can help ensure that a clinical trial system is categorized appropriately, based on the type of system and technology involved. Along with risk, system classification can provide a clear-cut pathway for validating a system, based on the appropriate level of testing and validation effort.
In this two day Virtual Seminar you will learn about FDA’s expectations for classifying, assessing the risk, testing, and validating a computer system used in clinical trial work. You will learn in detail about the System Development Life Cycle (SDLC) methodology used to approach Computer System Validation (CSV), including all of the phases, sequencing of events, deliverables, and documentation requirements.
All types of clinical trial systems will be discussed, including in-house developed code, configurable systems and custom-designed systems. Best industry practices and potential pitfalls in validating clinical trial systems, along with examples, will be covered in detail.
Ongoing maintenance of the system in a validated state will be discussed, as well as governance, archival and retirement.
This training day will also discuss the importance of applying good project management, business process re-engineering and organizational change management principles through the validation process and beyond.
Upon completing this course participants should:
- Understand FDA requirements for clinical trial Computer System Validation (CSV)
- Understand the System Development Life Cycle (SDLC) approach to validation
- Utilize GAMP 5 system classification and risk methodologies for categorizing systems and developing a validation pathway
- Understand how to build a complete validation strategy and program for clinical trial systems
- Know how to manage the validation process and create FDA-compliant documentation
- Know how to monitor a clinical trial system that is in production, governing the data and system through retirement
- Understand the roles and responsibilities required to validate a clinical trial system
- Know how to measure cost vs. compliance risk for a clinical trial system
- Understand good project management principles, incorporating business process re-engineering and organizational change management into the process
- Know the policies and procedures that must be developed and maintained to support the clinical trial system in operation
- Understand how to leverage the vendor and other external resources to apply the best industry practices and avoid potential pitfalls when validating a clinical trial system
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Know about FDA trends in oversight and audit of clinical trial systems and how to keep abreast of these
Key Topics Covered:
FDA oversight of computer systems used in regulated industries
- “GxPs” defined
- Focus on “GCPs”
- FDA audit and inspection objectives
- Company compliance objectives
Introduction to Clinical Data Systems (CDS)
Introduction to Computer System Validation (CSV)
System Development Life Cycle (SDLC) framework and validation
- SDLC phases (requirements, design, testing, implementation, acceptance, release to production, change control, retirement)
- SDLC deliverables, timing, and documentation
- The Requirements Traceability Matrix (RTM) – a key validation deliverable of interest to FDA
GAMP 5 and system classification
System risk assessment and management
- Clinical data system inventory
- Risk assessment, mitigation and prioritization
- Monitoring and managing system risk throughout a clinical data system’s SDLC
Building a solid project management plan to corral a clinical data system validation effort
- Validation strategy and planning
- Clinical data system implementation and validation execution
- Validation documentation
- System and data “owners” and “custodians”
- Roles and responsibilities
- Leveraging the vendor or other external resource
Incorporating business process re-engineering principles into the clinical data system validation effort
- Clinical process mapping
- Seeking opportunities for improvement
- Building improvement into the project plan
Incorporating Organizational Change Management (OCM) principles into the clinical data system validation effort
- Assessing the organization’s “appetite” for change
- Identifying “early adopters,” “laggards,” and “resisters”
- Effecting long-lasting change
Example – implementing and validating a clinical data system
Ongoing monitoring and management of a clinical data system in a validated state throughout the SDLC
- Operations and maintenance
- System and data backup and archival
- Change control board and best practices (high on FDA’s list for scrutiny)
- Periodic review and assessment for revalidation
- Policies and procedures (IT and user)
- Ongoing training and OCM
- Disaster Recovery (DR) planning and execution
- Business Continuity Planning (BCP) and execution
System and Data Governance Board
FDA’s strategy and direction – the “swinging pendulum”
- Recent trends in FDA findings related to clinical data systems
- Factors influencing FDA audit and inspection
- What does the future look like?
For more information about this training visit https://www.researchandmarkets.com/r/dpgj6o
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