Project Management for Computer System Validation (CSV) to Improve FDA Compliance
Enhance CSV Projects: Embrace Project Management!
Instructor :
Carolyn Troiano
Webinar ID:
10410
Date: JAN 14, 2025 (TUE)
Start Time: 9 AM PT - 1 PM PT
Duration: 4 Hrs.
What you will learn
- Master GxP Systems Identification, Planning, And Validation Management Skills.
- Explore SDLC For Validation, Enhancing Project Control And Oversight.
- Manage CSV Effectively With Project Management, Meeting FDA Requirements.
- Streamline Validation With CSA, Focusing On Critical Thinking, Risk-Based Testing.
- Conduct Vendor Audits, IQ For Cloud Services ….
- Master GxP Systems Identification, Planning, And Validation Management Skills.
- Explore SDLC For Validation, Enhancing Project Control And Oversight.
- Manage CSV Effectively With Project Management, Meeting FDA Requirements.
- Streamline Validation With CSA, Focusing On Critical Thinking, Risk-Based Testing.
- Conduct Vendor Audits, IQ For Cloud Services Validation, Include In Plan.
- Best Practices For Documenting CSV: Requirements To Operational Maintenance In Plan.
- Assure GxP Data Integrity, Identify Discrepancies Via Gap Assessments.
- Maintain System Validation Lifecycle With Comprehensive Activity And Task Tracking.
- Optimize Validation And Compliance Using Risk, Project Management
Course Description
As someone deeply involved in the intricacies of Computer System Validation (CSV) within FDA-regulated environments, you’re well-acquainted with the technical demands of ensuring your systems meet stringent regulatory standards.
However, it’s the integration of these technical tasks within the broader scope of project management that truly elevates the effectiveness and efficiency of CSV efforts. This is where our course, “Project Management for Computer System Validation (CSV) to Improve FDA Compliance,” makes a significant impact.
Managing the CSV process isn’t just about understanding the technicalities; it’s about effectively planning, executing, and overseeing these processes to align with project goals, timelines, and resources. This course acknowledges that challenge and is structured to address it by:
- Guiding you through planning and managing validation activities, not just as isolated tasks but as critical components of your project’s lifecycle, ensuring that every phase from initiation to closure is meticulously mapped and executed.
- Incorporating the System Development Life Cycle (SDLC) into your project management plans, which is pivotal for streamlining validation efforts. This ensures that project management principles are applied to manage the lifecycle of every validation project, enhancing oversight and control.
- Emphasizing the significance of vendor audits and Installation Qualification (IQ) within project planning, highlighting the project management tasks of vendor selection, evaluation, and how these elements are seamlessly integrated into the project’s timeline and deliverables.
- Focusing on the project documentation and maintenance of systems in a validated state, underlining the necessity of thorough documentation and continuous oversight, essential skills for any project manager aiming to maintain compliance and ensure project success.
- Utilizing risk assessments to develop a validation rationale, which reflects a core project management activity, underlining the importance of identifying, analyzing, and mitigating risks within the CSV process to inform strategic planning and decision-making.
- Preparing for FDA inspections or audits, a task that requires meticulous planning, readiness, and the ability to present and defend your validation efforts, underscoring the strategic planning and risk management aspects of project management.
In essence, this course is designed not just to enhance your understanding of the technical requirements of CSV but to empower you with project management strategies that optimize your CSV projects.
It bridges the gap between technical validation tasks and project management methodologies, ensuring that you’re equipped to lead your CSV projects with confidence, efficiency, and compliance.
Join Now!
As someone deeply involved in the intricacies of Computer System Validation (CSV) within FDA-regulated environments, you’re well-acquainted with the technical demands of ensuring your systems meet stringent regulatory standards.
However, it’s the integration of these technical tasks within the broader scope of project management that truly elevates the effectiveness and efficiency of CSV efforts. This is where our course, “Project Management for Computer System Validation (CSV) to Improve FDA Compliance,” makes a significant impact.
Managing the CSV process isn’t just about understanding the technicalities; it’s about effectively planning, executing, and overseeing these processes to align with project goals, timelines, and resources. This course acknowledges that challenge and is structured to address it by:
- Guiding you through planning and managing validation activities, not just as isolated tasks but as critical components of your project’s lifecycle, ensuring that every phase from initiation to closure is meticulously mapped and executed.
- Incorporating the System Development Life Cycle (SDLC) into your project management plans, which is pivotal for streamlining validation efforts. This ensures that project management principles are applied to manage the lifecycle of every validation project, enhancing oversight and control.
- Emphasizing the significance of vendor audits and Installation Qualification (IQ) within project planning, highlighting the project management tasks of vendor selection, evaluation, and how these elements are seamlessly integrated into the project’s timeline and deliverables.
- Focusing on the project documentation and maintenance of systems in a validated state, underlining the necessity of thorough documentation and continuous oversight, essential skills for any project manager aiming to maintain compliance and ensure project success.
- Utilizing risk assessments to develop a validation rationale, which reflects a core project management activity, underlining the importance of identifying, analyzing, and mitigating risks within the CSV process to inform strategic planning and decision-making.
- Preparing for FDA inspections or audits, a task that requires meticulous planning, readiness, and the ability to present and defend your validation efforts, underscoring the strategic planning and risk management aspects of project management.
In essence, this course is designed not just to enhance your understanding of the technical requirements of CSV but to empower you with project management strategies that optimize your CSV projects.
It bridges the gap between technical validation tasks and project management methodologies, ensuring that you’re equipped to lead your CSV projects with confidence, efficiency, and compliance.
Join Now!
Why you should attend
If you’re involved in the validation of computerized systems within the FDA-regulated industry, this course is your key to mastering project management specifically tailored to CSV.
In just 4 hours, gain crucial insights into:
- Streamlining validation efforts using CSA and risk-based approaches.
- Enhancing control over your projects with SDLC methodologies and project management best practices.
- Ensuring compliance with regulatory documentation and 21 CFR Part 11 standards.
Attendees will learn how to navigate regulatory requirements with confidence, maintain the integrity of GxP-relevant data, and prepare thoroughly for FDA inspections.
Whether you’re seeking to refine your project management skills, optimize validation processes, or ensure your projects remain compliant, this course offers the tools and insights needed to succeed.
This interactive course specifically addresses the intersection of project management principles and practices with the specialized needs of CSV, ensuring that participants gain insights that are directly applicable to their roles.
Don’t miss this opportunity to elevate your approach to CSV and become a leader in FDA compliance.
Enroll Now!
If you’re involved in the validation of computerized systems within the FDA-regulated industry, this course is your key to mastering project management specifically tailored to CSV.
In just 4 hours, gain crucial insights into:
- Streamlining validation efforts using CSA and risk-based approaches.
- Enhancing control over your projects with SDLC methodologies and project management best practices.
- Ensuring compliance with regulatory documentation and 21 CFR Part 11 standards.
Attendees will learn how to navigate regulatory requirements with confidence, maintain the integrity of GxP-relevant data, and prepare thoroughly for FDA inspections.
Whether you’re seeking to refine your project management skills, optimize validation processes, or ensure your projects remain compliant, this course offers the tools and insights needed to succeed.
This interactive course specifically addresses the intersection of project management principles and practices with the specialized needs of CSV, ensuring that participants gain insights that are directly applicable to their roles.
Don’t miss this opportunity to elevate your approach to CSV and become a leader in FDA compliance.
Enroll Now!
Course Agenda
- Learn how to identify “GxP” Systems, then plan and manage validation-related activities.
- Explore the System Development Life Cycle (SDLC) approach to validation and how to incorporate it into a project management plan for better control and oversight.
- Discuss how the Computer System Validation (CSV) approach, based on FDA requirements, can be managed more effectively using a project management approach.
- Learn about Computer Software Assurance (CSA) and how this approach may streamline your validation work by focusing on critical thinking and risk-based testing for each requirement.
- Discover the best approach for conducting vendor audits and performing Installation Qualification (IQ) for validation of cloud services and SaaS providers, including these in a project plan.
- Discuss best practices for documenting CSV efforts, including requirements, design/configuration, development, testing, and operational maintenance procedures, all linked in a plan.
- Learn about assuring the integrity of data that supports GxP work and using gap assessments to identify discrepancies.
- Understand how to maintain a system in a validated state throughout its entire life cycle by tracking all required activities and tasks.
- Discuss the importance of “GxP” documentation that complies with FDA requirements, including project artifacts.
- Learn about the policies and procedures needed to support your validation process and the ongoing maintenance of systems in a validated state.
- Understand the key components of 21 CFR Part 11 compliance for electronic records and signatures, and how to include these requirements in a project plan.
- Learn how to conduct a risk assessment on computer systems as the basis for developing a validation rationale, resulting in a comprehensive set of activities and tasks for the project.
- Know the regulatory influences that lead to the FDA’s current thinking at any given time and how to leverage this knowledge for ongoing work.
- Prepare for an FDA inspection or audit of a GxP computer system through meticulous documentation.
- Understand the importance of performing thorough vendor audits to ensure oversight of the products and services they deliver.
- Finally, understand industry best practices that enable you to optimize your approach to validation and compliance, based on risk assessment and project management, to ensure data integrity throughout the data life cycle.
- Q&A
BONUS:
- PDF copy of the presentation handout for your future reference.
- Soft copy of the certificate of completion on request.
- Q&A Session with the Presenter: Get your pressing questions answered verbally, via chat or email
- Learn how to identify “GxP” Systems, then plan and manage validation-related activities.
- Explore the System Development Life Cycle (SDLC) approach to validation and how to incorporate it into a project management plan for better control and oversight.
- Discuss how the Computer System Validation (CSV) approach, based on FDA requirements, can be managed more effectively using a project management approach.
- Learn about Computer Software Assurance (CSA) and how this approach may streamline your validation work by focusing on critical thinking and risk-based testing for each requirement.
- Discover the best approach for conducting vendor audits and performing Installation Qualification (IQ) for validation of cloud services and SaaS providers, including these in a project plan.
- Discuss best practices for documenting CSV efforts, including requirements, design/configuration, development, testing, and operational maintenance procedures, all linked in a plan.
- Learn about assuring the integrity of data that supports GxP work and using gap assessments to identify discrepancies.
- Understand how to maintain a system in a validated state throughout its entire life cycle by tracking all required activities and tasks.
- Discuss the importance of “GxP” documentation that complies with FDA requirements, including project artifacts.
- Learn about the policies and procedures needed to support your validation process and the ongoing maintenance of systems in a validated state.
- Understand the key components of 21 CFR Part 11 compliance for electronic records and signatures, and how to include these requirements in a project plan.
- Learn how to conduct a risk assessment on computer systems as the basis for developing a validation rationale, resulting in a comprehensive set of activities and tasks for the project.
- Know the regulatory influences that lead to the FDA’s current thinking at any given time and how to leverage this knowledge for ongoing work.
- Prepare for an FDA inspection or audit of a GxP computer system through meticulous documentation.
- Understand the importance of performing thorough vendor audits to ensure oversight of the products and services they deliver.
- Finally, understand industry best practices that enable you to optimize your approach to validation and compliance, based on risk assessment and project management, to ensure data integrity throughout the data life cycle.
- Q&A
BONUS:
- PDF copy of the presentation handout for your future reference.
- Soft copy of the certificate of completion on request.
- Q&A Session with the Presenter: Get your pressing questions answered verbally, via chat or email
Who is this course for
The following benefits from watching this. Even better when done as a group!
- Quality Assurance Manager
- Regulatory Affairs Specialist
- Compliance Officer
- Validation Engineer
- Quality Control Analyst
- IT Manager (in Pharmaceutical or Biotech Industry)
- Data Governance Specialist
- Computer System Validation (CSV) Specialist
- Clinical Data Manager
- Pharmaceutical Quality Systems Manager
- Risk Management Officer
- FDA Regulatory Consultant
- Clinical Research Coordinator
- Pharmacovigilance Associate
- Biotechnology Compliance Analyst
The following benefits from watching this. Even better when done as a group!
- Quality Assurance Manager
- Regulatory Affairs Specialist
- Compliance Officer
- Validation Engineer
- Quality Control Analyst
- IT Manager (in Pharmaceutical or Biotech Industry)
- Data Governance Specialist
- Computer System Validation (CSV) Specialist
- Clinical Data Manager
- Pharmaceutical Quality Systems Manager
- Risk Management Officer
- FDA Regulatory Consultant
- Clinical Research Coordinator
- Pharmacovigilance Associate
- Biotechnology Compliance Analyst
Instructor Profile
Carolyn (McKillop) Troiano has more than 40 years of experience 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, developing and executing compliance strategies and programs. Carolyn is currently active in the Association of Information Technology Professionals (AITP), and Project Management Institute (PMI) chapters in the Richmond, VA area.
During her career, Carolyn worked directly, or on a consulting basis, for many of the larger pharmaceutical companies in the US and Europe. She developed validation programs and strategies back in the mid-1980s, when the first FDA guidebook was published on the subject, and collaborated with FDA and other industry representatives on 21 CFR Part 11, the FDA’s electronic record/electronic signature regulation.
