FDA’s New CSA Framework: Simplifying Computer System Implementations and Ensuring Compliance
CSA vs. CSV—What You Need to Know for Easier Implementations!
Instructor :
Carolyn Troiano
Webinar ID:
11415
Date: DEC 06, 2024 (FRI)
Start Time: 10 AM PT - 11:30 AM PT
Duration: 90 Mins.
What you will learn
- Computer Software Assurance for Manufacturing and Quality Systems
- Understanding Differences Between CSA and CSV Models
- Identifying Computer Systems Applicable Under CSA
- Exploring Critical Risk Thinking in ….
- Computer Software Assurance for Manufacturing and Quality Systems
- Understanding Differences Between CSA and CSV Models
- Identifying Computer Systems Applicable Under CSA
- Exploring Critical Risk Thinking in CSA Implementation
- Determining Essential Performance Metrics for CSA Compliance
- Preparing for New FDA Guidance and Final Regulations
- Timeline for Adapting to the New CSA Approach
- Steps to Initiate Transition to CSA Methodology
- Next Steps for Ensuring Smooth Transition and Compliance
Course Description
The FDA is bringing a significant shift to the Computer System Validation (CSV) strategy with its new Computer System Assurance (CSA) methodology.
Expected to be implemented soon, this new guidance is designed to streamline the validation process by applying Quality Risk Management principles directly to computer systems.
In this 90-minute webinar, we will:
- Dissect the CSA approach to understand its core concepts.
- Explore the key matrices and tools essential for making solid risk determinations.
- Provide a framework that simplifies computer system implementations and ongoing maintenance.
Key questions will be addressed to ensure effective adoption of CSA, including:
- Does the software impact patient safety?
- How does the software affect product quality?
- What is the software’s impact on your quality system integrity?
Join us to gain the insights necessary to navigate this critical transition and ensure your systems are compliant and efficient under the new FDA guidance.
Join Now!
The FDA is bringing a significant shift to the Computer System Validation (CSV) strategy with its new Computer System Assurance (CSA) methodology.
Expected to be implemented soon, this new guidance is designed to streamline the validation process by applying Quality Risk Management principles directly to computer systems.
In this 90-minute webinar, we will:
- Dissect the CSA approach to understand its core concepts.
- Explore the key matrices and tools essential for making solid risk determinations.
- Provide a framework that simplifies computer system implementations and ongoing maintenance.
Key questions will be addressed to ensure effective adoption of CSA, including:
- Does the software impact patient safety?
- How does the software affect product quality?
- What is the software’s impact on your quality system integrity?
Join us to gain the insights necessary to navigate this critical transition and ensure your systems are compliant and efficient under the new FDA guidance.
Join Now!
Why you should attend
As the FDA transitions from Computer System Validation (CSV) to Computer System Assurance (CSA), staying ahead of this change is critical for professionals involved in compliance, quality assurance, and IT systems.
This webinar is not just an educational session—it’s your opportunity to gain a strategic advantage in navigating this shift effectively.
Here’s why this matters:
- Stay Compliant: The FDA’s shift to CSA is more than just a procedural update; it’s a paradigm shift in how risk is managed in computer systems. Understanding this new approach is essential to ensure your organization remains compliant with evolving regulatory expectations.
- Enhance Efficiency: The CSA framework is designed to streamline validation processes, reducing the time and resources required for system implementations and maintenance. By adopting these strategies, you can significantly enhance operational efficiency in your role.
- Risk Management Mastery: CSA emphasizes a risk-based approach, which means knowing how to identify, assess, and mitigate risks is more important than ever. The skills you gain from this webinar will empower you to make more informed decisions, directly impacting the quality and safety of your products.
- Future-Proof Your Career: As the industry moves towards CSA, professionals who are well-versed in this methodology will be in high demand. Attending this webinar will position you as a forward-thinking expert, ready to lead your organization through this critical transition.
Don’t miss this opportunity to equip yourself with the knowledge and tools to thrive in this new regulatory landscape. Join us and take the first step towards mastering CSA and driving success in your organization.
As the FDA transitions from Computer System Validation (CSV) to Computer System Assurance (CSA), staying ahead of this change is critical for professionals involved in compliance, quality assurance, and IT systems.
This webinar is not just an educational session—it’s your opportunity to gain a strategic advantage in navigating this shift effectively.
Here’s why this matters:
- Stay Compliant: The FDA’s shift to CSA is more than just a procedural update; it’s a paradigm shift in how risk is managed in computer systems. Understanding this new approach is essential to ensure your organization remains compliant with evolving regulatory expectations.
- Enhance Efficiency: The CSA framework is designed to streamline validation processes, reducing the time and resources required for system implementations and maintenance. By adopting these strategies, you can significantly enhance operational efficiency in your role.
- Risk Management Mastery: CSA emphasizes a risk-based approach, which means knowing how to identify, assess, and mitigate risks is more important than ever. The skills you gain from this webinar will empower you to make more informed decisions, directly impacting the quality and safety of your products.
- Future-Proof Your Career: As the industry moves towards CSA, professionals who are well-versed in this methodology will be in high demand. Attending this webinar will position you as a forward-thinking expert, ready to lead your organization through this critical transition.
Don’t miss this opportunity to equip yourself with the knowledge and tools to thrive in this new regulatory landscape. Join us and take the first step towards mastering CSA and driving success in your organization.
Course Agenda
- What Is Computer Software Assurance for Manufacturing, Operations, and Quality Systems?
- Understand the Differences Between CSA and CSV Models
- What Computer Systems Does CSA Apply To?
- What Is Critical Risk Thinking?
- What Performance Metrics Do I Need?
- When Do I Need to Be Prepared for the New Approach and Final Guidance/Regulations?
- Where to Start in Your Transition and Next Steps?
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
- What Is Computer Software Assurance for Manufacturing, Operations, and Quality Systems?
- Understand the Differences Between CSA and CSV Models
- What Computer Systems Does CSA Apply To?
- What Is Critical Risk Thinking?
- What Performance Metrics Do I Need?
- When Do I Need to Be Prepared for the New Approach and Final Guidance/Regulations?
- Where to Start in Your Transition and Next Steps?
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 (IT) Analysts
- IT Developers, IT Support Staff
- QC/QA Managers and Analysts
- Manufacturing Personnel
- Clinical Data Managers and Scientists
- Compliance Managers and Auditors
- Lab Managers and Analysts
- Supply Chain Personnel
- Computer System Validation Specialists
- GMP Training Specialists
- Business Stakeholders using Computer Systems regulated by FDA
- Regulatory Affairs Personnel
- Software Development Companies and Personnel (develop software for the medical device industry)
- Consultants in the Life Sciences and Tobacco Industries
Maximize The Learning Experience in A Group Setting!
- Information Technology (IT) Analysts
- IT Developers, IT Support Staff
- QC/QA Managers and Analysts
- Manufacturing Personnel
- Clinical Data Managers and Scientists
- Compliance Managers and Auditors
- Lab Managers and Analysts
- Supply Chain Personnel
- Computer System Validation Specialists
- GMP Training Specialists
- Business Stakeholders using Computer Systems regulated by FDA
- Regulatory Affairs Personnel
- Software Development Companies and Personnel (develop software for the medical device industry)
- Consultants in the Life Sciences and Tobacco Industries
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.
