Optimizing Software Compliance: Navigating Traditional Computer System Validation (CSV) vs. Modern Computer Software Assurance (CSA)
Are Your Validation Processes Keeping Pace With FDA’s Modernization?
Instructor :
Carolyn Troiano
Webinar ID:
11610
Date: DEC 11, 2024 (WED)
Start Time: 10 AM PT - 11:30 AM PT
Duration: 90 Mins.
What will you learn
-
- Understand FDA’s Current Thinking On Technology And Software Development.
- Identify “GxP” Systems And Their Compliance Importance.
- Explore GAMP®5 And Its Alignment With Computer Software Assurance (CSA).
- Modernize SDLC Validation Using Agile Approach And Automated Testing.
- Compare Agile Vs. Waterfall Approaches For Validation.
- Embrace Cloud Computing And SaaS For Effective Validation.
- Implement Best Practices For….
-
- Understand FDA’s Current Thinking On Technology And Software Development.
- Identify “GxP” Systems And Their Compliance Importance.
- Explore GAMP®5 And Its Alignment With Computer Software Assurance (CSA).
- Modernize SDLC Validation Using Agile Approach And Automated Testing.
- Compare Agile Vs. Waterfall Approaches For Validation.
- Embrace Cloud Computing And SaaS For Effective Validation.
- Implement Best Practices For Documenting Validation Efforts.
- Ensure Data Integrity Despite Advances In New Technology.
- Optimize Validation And Compliance Based On Risk Assessment.
Course Description
In today’s rapidly evolving technology landscape, organizations must rethink traditional business models to keep pace with increasing complexity and the heightened expectations of well-informed customers and patients.
To meet these challenges, both work practices and tools need to adapt.
This 90-minute webinar will explore the development, validation, and maintenance of software systems throughout their entire lifecycle.
We’ll compare the Agile and Waterfall methodologies, discussing the pros and cons of each, and highlight the importance of selecting the right approach based on your organization’s specific needs.
Key Highlights:
-
- Case for Quality Program: Learn how the US FDA’s Center for Devices and Radiological Health has identified a shift from compliance-centric approaches to a quality-first mindset that leverages automation and digital technologies.
- Risk-Based Approach: Understand the significance of a risk-based, product quality, and patient-centric approach to Computer System Assurance (CSA), as opposed to the traditional Computer System Validation (CSV) Waterfall approach.
- FDA Insights: Discover how the FDA allows flexibility in “HOW” compliance can be achieved, moving away from a rigid “checklist” mindset.
- GAMP®5 and Agile: Explore how GAMP®5 supports incremental, iterative, and evolutionary approaches, including Agile, in developing custom applications, emphasizing the importance of a robust Quality Management System and well-trained teams.
By the end of this session, you’ll gain a deeper understanding of how to apply modern practices to improve software quality and ensure compliance, balancing innovation with regulatory requirements.
Join Now!
In today’s rapidly evolving technology landscape, organizations must rethink traditional business models to keep pace with increasing complexity and the heightened expectations of well-informed customers and patients.
To meet these challenges, both work practices and tools need to adapt.
This 90-minute webinar will explore the development, validation, and maintenance of software systems throughout their entire lifecycle.
We’ll compare the Agile and Waterfall methodologies, discussing the pros and cons of each, and highlight the importance of selecting the right approach based on your organization’s specific needs.
Key Highlights:
-
- Case for Quality Program: Learn how the US FDA’s Center for Devices and Radiological Health has identified a shift from compliance-centric approaches to a quality-first mindset that leverages automation and digital technologies.
- Risk-Based Approach: Understand the significance of a risk-based, product quality, and patient-centric approach to Computer System Assurance (CSA), as opposed to the traditional Computer System Validation (CSV) Waterfall approach.
- FDA Insights: Discover how the FDA allows flexibility in “HOW” compliance can be achieved, moving away from a rigid “checklist” mindset.
- GAMP®5 and Agile: Explore how GAMP®5 supports incremental, iterative, and evolutionary approaches, including Agile, in developing custom applications, emphasizing the importance of a robust Quality Management System and well-trained teams.
By the end of this session, you’ll gain a deeper understanding of how to apply modern practices to improve software quality and ensure compliance, balancing innovation with regulatory requirements.
Join Now!
Why you should attend
In an era where technology is rapidly evolving, it is crucial to stay ahead by understanding the FDA’s approach to modernizing software compliance and validation.
This webinar offers a unique opportunity to learn how these advancements will benefit both the Agency and the industry, helping you to align your practices with current and future regulatory expectations.
One of the key takeaways from this session will be an in-depth discussion on how to modernize the System Development Life Cycle (SDLC) approach to Computer System Validation (CSV).
You’ll discover the benefits of integrating automated testing tools into your processes, which enable continuous validation of software products. This not only enhances efficiency but also ensures that your systems remain compliant throughout their lifecycle.
We will explore how this continuous validation approach is particularly compatible with the Agile software development methodology. You’ll learn how Agile, traditionally known for its flexibility and speed, can be effectively adapted for use in the validation process, creating a more streamlined and responsive system.
In addition to the technical aspects, this webinar will cover the essential elements of CSV that remain relevant in today’s technological landscape. You’ll gain insights on how to apply these principles within a modern environment, ensuring that your validation processes are both robust and future-proof.
By attending this webinar, you will:
-
- Gain a deeper understanding of the FDA’s modernization efforts and their implications for your organization.
- Learn how to implement automated testing tools for continuous validation, making your SDLC more efficient and compliant.
- Discover how to integrate Agile methodologies into your validation processes, balancing speed and accuracy.
- Understand how to apply traditional CSV principles in a modern technological context, ensuring that your systems meet both current and future regulatory standards.
This session is designed for professionals who are looking to optimize their software validation processes, stay compliant with evolving regulations, and leverage the latest technological advancements to improve quality and efficiency.
Whether you are a seasoned expert or new to the field, this webinar will provide you with actionable insights and practical strategies to enhance your organization’s approach to Computer System Validation and Computer Software Assurance.
Enroll Now!
In an era where technology is rapidly evolving, it is crucial to stay ahead by understanding the FDA’s approach to modernizing software compliance and validation.
This webinar offers a unique opportunity to learn how these advancements will benefit both the Agency and the industry, helping you to align your practices with current and future regulatory expectations.
One of the key takeaways from this session will be an in-depth discussion on how to modernize the System Development Life Cycle (SDLC) approach to Computer System Validation (CSV).
You’ll discover the benefits of integrating automated testing tools into your processes, which enable continuous validation of software products. This not only enhances efficiency but also ensures that your systems remain compliant throughout their lifecycle.
We will explore how this continuous validation approach is particularly compatible with the Agile software development methodology. You’ll learn how Agile, traditionally known for its flexibility and speed, can be effectively adapted for use in the validation process, creating a more streamlined and responsive system.
In addition to the technical aspects, this webinar will cover the essential elements of CSV that remain relevant in today’s technological landscape. You’ll gain insights on how to apply these principles within a modern environment, ensuring that your validation processes are both robust and future-proof.
By attending this webinar, you will:
-
- Gain a deeper understanding of the FDA’s modernization efforts and their implications for your organization.
- Learn how to implement automated testing tools for continuous validation, making your SDLC more efficient and compliant.
- Discover how to integrate Agile methodologies into your validation processes, balancing speed and accuracy.
- Understand how to apply traditional CSV principles in a modern technological context, ensuring that your systems meet both current and future regulatory standards.
This session is designed for professionals who are looking to optimize their software validation processes, stay compliant with evolving regulations, and leverage the latest technological advancements to improve quality and efficiency.
Whether you are a seasoned expert or new to the field, this webinar will provide you with actionable insights and practical strategies to enhance your organization’s approach to Computer System Validation and Computer Software Assurance.
Enroll Now!
Areas Covered
-
- Understand FDA’s Current Thinking on Technology and Software Development, and How It Impacts the Industry
- Learn How to Identify “GxP” Systems and Their Importance in Compliance
- Discuss the Current State of Computer System Validation (CSV) Based on FDA Requirements
- Explore GAMP®5, Second Edition (Published July 2022), and Its Alignment with Computer Software Assurance (CSA) and FDA’s Recent Draft Guidance for Validation
- Understand the System Development Life Cycle (SDLC) Approach to Validation and How It Can Be Modernized with an Agile Approach, Including Automated Testing for Continuous Validation
- Compare the Pros and Cons of Agile vs. Waterfall Approaches
- Discuss Cloud Computing and Software as a Service (SaaS) Systems That Can Be Embraced and Validated Effectively
- Learn Best Practices for Documenting Computer System Validation Efforts Using Either Waterfall or Agile Approaches, Including Requirements, Design, Development, Testing, and Operational Maintenance Procedures
- Discover Ways to Improve Efficiency and Effectiveness in Managing Validation Documentation
- Understand How to Maintain a System in a Validated State Throughout Its Entire Life Cycle in a More Cost-Effective Manner by Applying an Agile Continuous Validation Approach
- Learn How to Assure the Integrity of Data Supporting GxP Work, Despite Advances in New Technology
- Discuss the Importance of “GxP” Documentation That Complies with FDA Requirements
- Learn About the Policies and Procedures Needed to Support Your Validation Process and Ongoing Maintenance of Your Systems in a Validated State
- Know the Regulatory Influences Shaping FDA’s Current Thinking
- Understand Industry Best Practices to Optimize Your Approach to Validation and Compliance, Based on Risk Assessment, Ensuring Data Integrity Is Maintained Throughout the Entire Data Life Cycle
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
-
- Understand FDA’s Current Thinking on Technology and Software Development, and How It Impacts the Industry
- Learn How to Identify “GxP” Systems and Their Importance in Compliance
- Discuss the Current State of Computer System Validation (CSV) Based on FDA Requirements
- Explore GAMP®5, Second Edition (Published July 2022), and Its Alignment with Computer Software Assurance (CSA) and FDA’s Recent Draft Guidance for Validation
- Understand the System Development Life Cycle (SDLC) Approach to Validation and How It Can Be Modernized with an Agile Approach, Including Automated Testing for Continuous Validation
- Compare the Pros and Cons of Agile vs. Waterfall Approaches
- Discuss Cloud Computing and Software as a Service (SaaS) Systems That Can Be Embraced and Validated Effectively
- Learn Best Practices for Documenting Computer System Validation Efforts Using Either Waterfall or Agile Approaches, Including Requirements, Design, Development, Testing, and Operational Maintenance Procedures
- Discover Ways to Improve Efficiency and Effectiveness in Managing Validation Documentation
- Understand How to Maintain a System in a Validated State Throughout Its Entire Life Cycle in a More Cost-Effective Manner by Applying an Agile Continuous Validation Approach
- Learn How to Assure the Integrity of Data Supporting GxP Work, Despite Advances in New Technology
- Discuss the Importance of “GxP” Documentation That Complies with FDA Requirements
- Learn About the Policies and Procedures Needed to Support Your Validation Process and Ongoing Maintenance of Your Systems in a Validated State
- Know the Regulatory Influences Shaping FDA’s Current Thinking
- Understand Industry Best Practices to Optimize Your Approach to Validation and Compliance, Based on Risk Assessment, Ensuring Data Integrity Is Maintained Throughout the Entire Data Life Cycle
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
Maximize The Learning Experience in A Group Setting!
-
- Information Technology Analysts
- Information Technology Developers and Testers
- Software Quality Assurance Professionals
- QC/QA Managers and Analysts
- Analytical Chemists
- Compliance and Audit Managers
- Laboratory Managers
- Automation Analysts
- Manufacturing Specialists and Managers
- Supply Chain Specialists and Managers
- Regulatory Affairs Specialists
- Regulatory Submissions Specialists
- Risk Management Professionals
- Clinical Data Analysts
- Clinical Data Managers
- Clinical Trial Sponsors
- Computer System Validation Specialists
- GMP Training Specialists
- Business Stakeholders/Subject Matter Experts
- Business System/Application Testers
- Vendors responsible for software development, testing and maintenance
- Vendors and consultants working in the life sciences industry who are involved in computer system implementation, validation and compliance
Maximize The Learning Experience in A Group Setting!
-
- Information Technology Analysts
- Information Technology Developers and Testers
- Software Quality Assurance Professionals
- QC/QA Managers and Analysts
- Analytical Chemists
- Compliance and Audit Managers
- Laboratory Managers
- Automation Analysts
- Manufacturing Specialists and Managers
- Supply Chain Specialists and Managers
- Regulatory Affairs Specialists
- Regulatory Submissions Specialists
- Risk Management Professionals
- Clinical Data Analysts
- Clinical Data Managers
- Clinical Trial Sponsors
- Computer System Validation Specialists
- GMP Training Specialists
- Business Stakeholders/Subject Matter Experts
- Business System/Application Testers
- Vendors responsible for software development, testing and maintenance
- Vendors and consultants working in the life sciences industry who are involved in computer system implementation, validation and compliance
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.
