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FDA Compliance and Clinical Trial Computer System Validation

Recorded Session

90 Minutes

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This webinar 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 used in the conduct of clinical trials that are 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. Participants will learn about the specific aspects of clinical systems the data required, and how to meet compliance.

WHY SHOULD YOU ATTEND?

Learn how to reduce the time and labor involved in a computer system validation effort by adequately planning your project
Learn how to leverage past validation efforts to optimize results
Learn how to ensure your team members are adequately trained to implement and maintain an FDA-regulated computer system in order to manage a successful outcome
Learn how efficient and effective testing can ensure that all deficiencies are captured before a system is put into production, allowing for a smooth go-live without delay
Learn how to keep on top of changes to the system over time to ensure it is maintained in a validated state and does not require a complete revalidation due to neglect
Learn how to manage organizational change at the outset of a new system implementation project in order to avoid sabotage and other attempts to resist new ways of conducting business
Learn how to evaluate business processes to ensure that these are optimized as the system is being developed and/or configured to enable improvements in the efficiency and effectiveness of operations that will save money in the longer run
Learn how to document all validation work in order to ensure that revisits to the deliverables during subsequent system changes are efficient and do not require extra labor to dig through poorly documented information
Learn about potential pitfalls to the validation process through real industry examples
Learn how to avoid and/or mitigate potential pitfalls during the validation process

AREA COVERED

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))
Clinical Data Collection and Management Systems
Clinical Trials
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 links design to functional requirements
Test Planning, including the 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

LEARNING OBJECTIVES

Gain an understanding of the System Development Life Cycle (SDLC) Methodology
Develop the ability to apply the SDLC when validating computer systems in your organization
Understand the best practices for maintaining a computer system in a validated state
Discuss the best practices necessary to ensure all clinical trial data collection and management 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 clinical trial data collection and management systems in your organization and how they are maintained in a validated state
Learn how to gain information about trends in validation, as the industry progresses and new best practices emerge
Understand some of the key “pitfalls” to avoid when applying the SDLC methodology

WHO WILL BENEFIT?

Information Technology (IT) Analysts
IT Developers
IT Support Staff
QC/QA Managers and Analysts
Clinical Data Managers and Scientists
Analytical Chemists
Quality Managers, Chemists, and Microbiologists
Compliance Managers and Auditors
Lab Managers and Analysts
Automation Analysts
Computer System Validation Specialists
GMP Training Specialists
Business Stakeholders using Computer Systems regulated by FDA
Regulatory Affairs Personnel
Consultants

Learn how to reduce the time and labor involved in a computer system validation effort by adequately planning your project
Learn how to leverage past validation efforts to optimize results
Learn how to ensure your team members are adequately trained to implement and maintain an FDA-regulated computer system in order to manage a successful outcome
Learn how efficient and effective testing can ensure that all deficiencies are captured before a system is put into production, allowing for a smooth go-live without delay
Learn how to keep on top of changes to the system over time to ensure it is maintained in a validated state and does not require a complete revalidation due to neglect
Learn how to manage organizational change at the outset of a new system implementation project in order to avoid sabotage and other attempts to resist new ways of conducting business
Learn how to evaluate business processes to ensure that these are optimized as the system is being developed and/or configured to enable improvements in the efficiency and effectiveness of operations that will save money in the longer run
Learn how to document all validation work in order to ensure that revisits to the deliverables during subsequent system changes are efficient and do not require extra labor to dig through poorly documented information
Learn about potential pitfalls to the validation process through real industry examples
Learn how to avoid and/or mitigate potential pitfalls during the validation process

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))
Clinical Data Collection and Management Systems
Clinical Trials
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 links design to functional requirements
Test Planning, including the 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

Gain an understanding of the System Development Life Cycle (SDLC) Methodology
Develop the ability to apply the SDLC when validating computer systems in your organization
Understand the best practices for maintaining a computer system in a validated state
Discuss the best practices necessary to ensure all clinical trial data collection and management 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 clinical trial data collection and management systems in your organization and how they are maintained in a validated state
Learn how to gain information about trends in validation, as the industry progresses and new best practices emerge
Understand some of the key “pitfalls” to avoid when applying the SDLC methodology

Information Technology (IT) Analysts
IT Developers
IT Support Staff
QC/QA Managers and Analysts
Clinical Data Managers and Scientists
Analytical Chemists
Quality Managers, Chemists, and Microbiologists
Compliance Managers and Auditors
Lab Managers and Analysts
Automation Analysts
Computer System Validation Specialists
GMP Training Specialists
Business Stakeholders using Computer Systems regulated by FDA
Regulatory Affairs Personnel
Consultants

Currency:

Webinar Option

Price

Total

Transcript (PDF Transcript of the Training)

149

Downloadable Recorded Session

219

USB

299

Speaker Profile

Carolyn Troiano

Carolyn Troiano has more than 35 years of experience in computer system validation in the tobacco, pharmaceutical, medical device and other FDA-regulated industries. She has worked directly, or on a consulting basis, for many of the larger pharmaceutical and tobacco companies in the US and Europe. She is currently building an FDA computer system validation compliance strategy at a vapor company. Carolyn has participated in industry conferences, and is currently active in the Association of Information Technology Professionals (AITP), and Project Management Institute (PMI) chapters in the Richmond, VA area. Carolyn also volunteers for the PMI’s Educational Fund as a …

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FDA Compliance and Clinical Trial Computer System Validation

WHY SHOULD YOU ATTEND?

AREA COVERED

LEARNING OBJECTIVES

WHO WILL BENEFIT?

Currency:

Speaker Profile

Upcoming Webinars

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