The Digital Compliance Revolution: Master the Latest FDA CSV Trends
From Legacy to Digital – Keep Up with Evolving FDA Trends in CSV!
Instructor :
Carolyn Troiano
Webinar ID:
12807
Date: JAN 16, 2025 (THU)
Start Time: 10 AM PT - 11:30 AM PT
Duration: 90 Mins.
What will you learn
-
- Master GxP System Identification For Streamlined Compliance Processes.
- Understand FDA Technology Trends And Regulatory Impact On Validation.
- Modernize CSV With Agile SDLC And Risk-Based Approaches.
- Validate Cloud And SaaS Solutions While Ensuring Data Integrity.
- Streamline Validation Documentation For Efficiency And Audit Readiness.
- Implement Cost-Effective Maintenance While ….
-
- Master GxP System Identification For Streamlined Compliance Processes.
- Understand FDA Technology Trends And Regulatory Impact On Validation.
- Modernize CSV With Agile SDLC And Risk-Based Approaches.
- Validate Cloud And SaaS Solutions While Ensuring Data Integrity.
- Streamline Validation Documentation For Efficiency And Audit Readiness.
- Implement Cost-Effective Maintenance While Ensuring Continuous Compliance.
- Apply Best Practices And Optimize Systems With Expert Guidance.
Course Description
As 2024 comes to a close, FDA-regulated industries are navigating a transformative era in compliance.
The focus is shifting from traditional, document-heavy practices to risk-based, quality-centric approaches that leverage the latest digital technologies. Are you ready to stay ahead in this evolving landscape?
This 90-minute interactive webinar provides the insights and tools you need to succeed:
-
- Harness the Power of Automation: Discover why investing in digital technologies is key to improving process control and achieving compliance efficiency.
- Transition from CSV to CSA: Dive into the FDA’s shift to Computer System Assurance (CSA), a model that prioritizes risk management and critical thinking over prescriptive documentation.
- Agile vs. Waterfall Methodologies: Compare these approaches to system validation and learn how to align with GAMP5’s iterative, flexible recommendations.
- Break Free from the Checklist Mindset: Learn how to tailor your compliance processes to address specific risks effectively while maintaining FDA standards.
By attending, you’ll:
-
- Master the latest compliance trends and strategies for 2024 and beyond.
- Strengthen your Quality Management System (QMS) using tools and automation.
- Equip your team to adapt to FDA’s evolving expectations with confidence.
This webinar is designed for quality assurance professionals, compliance managers, and regulated industry leaders aiming to embrace innovative compliance strategies and ensure their practices align with the FDA’s modern framework.
The FDA’s focus is clear—compliance is not just about the “WHAT” but the “HOW.” With the right strategies, you can redefine your approach to compliance and quality.
Don’t wait—secure your spot today to stay ahead in 2024’s compliance revolution!
Enroll Now!
As 2024 comes to a close, FDA-regulated industries are navigating a transformative era in compliance.
The focus is shifting from traditional, document-heavy practices to risk-based, quality-centric approaches that leverage the latest digital technologies. Are you ready to stay ahead in this evolving landscape?
This 90-minute interactive webinar provides the insights and tools you need to succeed:
-
- Harness the Power of Automation: Discover why investing in digital technologies is key to improving process control and achieving compliance efficiency.
- Transition from CSV to CSA: Dive into the FDA’s shift to Computer System Assurance (CSA), a model that prioritizes risk management and critical thinking over prescriptive documentation.
- Agile vs. Waterfall Methodologies: Compare these approaches to system validation and learn how to align with GAMP5’s iterative, flexible recommendations.
- Break Free from the Checklist Mindset: Learn how to tailor your compliance processes to address specific risks effectively while maintaining FDA standards.
By attending, you’ll:
-
- Master the latest compliance trends and strategies for 2024 and beyond.
- Strengthen your Quality Management System (QMS) using tools and automation.
- Equip your team to adapt to FDA’s evolving expectations with confidence.
This webinar is designed for quality assurance professionals, compliance managers, and regulated industry leaders aiming to embrace innovative compliance strategies and ensure their practices align with the FDA’s modern framework.
The FDA’s focus is clear—compliance is not just about the “WHAT” but the “HOW.” With the right strategies, you can redefine your approach to compliance and quality.
Don’t wait—secure your spot today to stay ahead in 2024’s compliance revolution!
Enroll Now!
Why you should attend
This webinar is designed to equip you with the tools and strategies to navigate these challenges effectively and elevate your compliance game.
Why You Should Attend:
-
- Master FDA’s Latest Compliance Expectations: Gain insights into the FDA’s increased focus on data integrity, risk assessments, and system governance—crucial for maintaining secure, compliant systems.
- Embrace Technology to Lead, Not Follow: Learn how leveraging advanced tools and methodologies can help you adapt to an increasingly complex environment and exceed the expectations of well-informed patients and customers.
- Modernize Your Validation Practices: Understand how to transition from traditional CSV (Computer System Validation) approaches to a dynamic, risk-based CSA (Computer System Assurance) framework.
- Boost Agility in Software Development and Maintenance: Discover how agile methodologies can make validation processes faster, more efficient, and more responsive to your organization’s needs.
- Future-Proof Your Skills: Build expertise in modern System Development Life Cycles (SDLCs) and automated testing tools for continuous validation and compliance.
Key Takeaways:
-
- Transform your approach to software validation and system governance.
- Learn to implement agile methodologies tailored to validation and compliance.
- Enhance your ability to manage evolving regulatory requirements with confidence.
- Ensure your organization is not just compliant but also leading in innovation.
This course is ideal for professionals in quality assurance, compliance, and regulated industries seeking to modernize their practices, ensure regulatory excellence, and stay competitive in a digital-first world.
Don’t miss this opportunity to become a leader in compliance innovation.
Reserve your spot today!
This webinar is designed to equip you with the tools and strategies to navigate these challenges effectively and elevate your compliance game.
Why You Should Attend:
-
- Master FDA’s Latest Compliance Expectations: Gain insights into the FDA’s increased focus on data integrity, risk assessments, and system governance—crucial for maintaining secure, compliant systems.
- Embrace Technology to Lead, Not Follow: Learn how leveraging advanced tools and methodologies can help you adapt to an increasingly complex environment and exceed the expectations of well-informed patients and customers.
- Modernize Your Validation Practices: Understand how to transition from traditional CSV (Computer System Validation) approaches to a dynamic, risk-based CSA (Computer System Assurance) framework.
- Boost Agility in Software Development and Maintenance: Discover how agile methodologies can make validation processes faster, more efficient, and more responsive to your organization’s needs.
- Future-Proof Your Skills: Build expertise in modern System Development Life Cycles (SDLCs) and automated testing tools for continuous validation and compliance.
Key Takeaways:
-
- Transform your approach to software validation and system governance.
- Learn to implement agile methodologies tailored to validation and compliance.
- Enhance your ability to manage evolving regulatory requirements with confidence.
- Ensure your organization is not just compliant but also leading in innovation.
This course is ideal for professionals in quality assurance, compliance, and regulated industries seeking to modernize their practices, ensure regulatory excellence, and stay competitive in a digital-first world.
Don’t miss this opportunity to become a leader in compliance innovation.
Reserve your spot today!
Areas Covered
-
- Identify “GxP” Systems Easily: Learn how to quickly identify Good Automated Manufacturing Practice (GxP) systems and ensure their compliance with FDA regulations.
- FDA Tech & Software Insights: Understand the FDA’s latest views on emerging technologies and their impact on software development, validation, and compliance.
- Modernize CSV Approaches: Update your Computer System Validation (CSV) strategies to align with the latest FDA requirements and best practices.
- Agile SDLC Validation: Discover how to apply agile software development life cycle (SDLC) techniques to streamline validation and ensure ongoing compliance.
- Agile vs. Waterfall: The Breakdown: Explore the strengths and weaknesses of both agile and waterfall methodologies for validation, and determine which is best for your organization’s needs.
- Cloud Computing & SaaS Mastery: Learn how to implement and validate cloud-based and SaaS solutions to ensure they meet compliance standards and enhance operational efficiency.
- Efficient Validation Documentation: Streamline your validation documentation process for any approach, improving both efficiency and effectiveness.
- Cost-Effective System Maintenance: Understand strategies for maintaining systems in a validated state while keeping costs under control.
- Data Integrity in Tech Advances: Ensure data integrity remains a priority amidst the rapid pace of technological advancements and digital transformation.
- GxP Documentation Compliance: Master the creation of FDA-compliant GxP documentation for improved audit readiness and compliance verification.
- Validation Support Strategies: Learn to develop policies and procedures that support ongoing system maintenance and ensure continuous compliance.
- Grasp FDA Regulatory Influences: Stay up to date on the regulatory influences driving FDA decision-making and their impact on your compliance efforts.
- Optimize with Best Practices: Implement industry best practices for validation and compliance, driven by risk assessment and aligned with the latest FDA guidance.
- Interactive Q&A Session: Engage in a live Q&A to clarify any doubts, deepen your understanding, and get personalized advice from the experts.
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
-
- Identify “GxP” Systems Easily: Learn how to quickly identify Good Automated Manufacturing Practice (GxP) systems and ensure their compliance with FDA regulations.
- FDA Tech & Software Insights: Understand the FDA’s latest views on emerging technologies and their impact on software development, validation, and compliance.
- Modernize CSV Approaches: Update your Computer System Validation (CSV) strategies to align with the latest FDA requirements and best practices.
- Agile SDLC Validation: Discover how to apply agile software development life cycle (SDLC) techniques to streamline validation and ensure ongoing compliance.
- Agile vs. Waterfall: The Breakdown: Explore the strengths and weaknesses of both agile and waterfall methodologies for validation, and determine which is best for your organization’s needs.
- Cloud Computing & SaaS Mastery: Learn how to implement and validate cloud-based and SaaS solutions to ensure they meet compliance standards and enhance operational efficiency.
- Efficient Validation Documentation: Streamline your validation documentation process for any approach, improving both efficiency and effectiveness.
- Cost-Effective System Maintenance: Understand strategies for maintaining systems in a validated state while keeping costs under control.
- Data Integrity in Tech Advances: Ensure data integrity remains a priority amidst the rapid pace of technological advancements and digital transformation.
- GxP Documentation Compliance: Master the creation of FDA-compliant GxP documentation for improved audit readiness and compliance verification.
- Validation Support Strategies: Learn to develop policies and procedures that support ongoing system maintenance and ensure continuous compliance.
- Grasp FDA Regulatory Influences: Stay up to date on the regulatory influences driving FDA decision-making and their impact on your compliance efforts.
- Optimize with Best Practices: Implement industry best practices for validation and compliance, driven by risk assessment and aligned with the latest FDA guidance.
- Interactive Q&A Session: Engage in a live Q&A to clarify any doubts, deepen your understanding, and get personalized advice from the experts.
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!
-
- Leaders Seeking to Enhance Team Performance and Drive Compliance Success
- Department Heads Tasked with Ensuring Compliance Across Multiple Systems
- Professionals Struggling with Outdated Validation Approaches
- Training Managers Designing Learning Paths for Team Development
- HR Professionals Addressing Skill Gaps in Regulatory Compliance
- IT Specialists Overseeing System Validation and Maintenance
- Quality Assurance Experts Improving Data Integrity and Process Efficiency
- Compliance Officers Facing Increased Regulatory Scrutiny
- Healthcare and Pharma Professionals Navigating Complex Technological Transformations
The following benefits from watching this. Even better when done as a group!
-
- Leaders Seeking to Enhance Team Performance and Drive Compliance Success
- Department Heads Tasked with Ensuring Compliance Across Multiple Systems
- Professionals Struggling with Outdated Validation Approaches
- Training Managers Designing Learning Paths for Team Development
- HR Professionals Addressing Skill Gaps in Regulatory Compliance
- IT Specialists Overseeing System Validation and Maintenance
- Quality Assurance Experts Improving Data Integrity and Process Efficiency
- Compliance Officers Facing Increased Regulatory Scrutiny
- Healthcare and Pharma Professionals Navigating Complex Technological Transformations
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.
