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Who should attend FDA Compliance and Clinical Trial Computer System Validation: 2-Day In-person Seminar
Data Owners, Data Stewards, Information Technology Analysts, Information Technology Developers and Testers, QC/QA Managers and Analysts, Clinical Data Managers and Scientists, Analytical Chemists, Compliance and Audit Managers, Laboratory Managers, Automation Analysts
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Seminar Summary:

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  (see full course description)

 
 
 

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Training Course Syllabus:


FDA Compliance and Clinical Trial Computer System Validation

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 workshop conference 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.

We 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.

Learning Objectives:
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
Know about FDA trends in oversight and audit of clinical trial systems and how to keep abreast of these

Course Outline:
Day One (8:30 AM – 4:30 PM)

Registration Process: 8:30 AM – 9:00 AM
Session Start Time: 9:00 AM

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)
Defining the types of systems
System evaluation, scoring and selection process overview
Discussion of industry trends in system usage
Introduction to Computer System Validation (CSV)
FDA’s Guidance for Computerized System Validation (1983)
Evolution of validation
21 CFR Part 11 (electronic records/electronic signatures; 1987)
Industries (pharmaceutical, medical device, biotechnology, tobacco, organ donation)
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
GAMP 5 system categories and criteria
Using GAMP 5 to develop an approach to CSV for a clinical data system
Evolving technology – driving a mobile application across a data lake and into the cloud
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
Lunch Break

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

Day Two (8:30 AM – 4:30 PM)

Example – implementing and validating a clinical data system
Situation overview
Building a strategy
Managing the project using the CSV principles, SDLC methodology and good project management practices
SDLC phases, deliverables and templates
Incorporating BPR and OCM practices
Focus on testing as key area of FDA scrutiny
Wrapping up the documentation package
Clinical data system acceptance and release
Policies and procedures
Training – timing and best approach
Turnover to support
Ongoing validation maintenance
System retirement and data archival
Lunch Break

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
Board Charter
Sponsorship
Roles and responsibilities
Meetings and status reporting
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?
Wrap-up/ Q&A

Seminar Summary:

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  (see full course description)

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