Instructor :
Carolyn Troiano

Webinar ID:
9568

Data is at the heart of FDA’s work as a science-based agency. We’re witnessing rapid increases in the amount and complexity of data that informs the FDA’s regulatory decision-making and public health mission. But how is this data truly being utilized?

As part of the Case for Quality program, the US FDA Center for Devices and Radiological Health noted an intriguing trend: an excessive focus by industry on compliance rather than quality.

This focus might be diverting resources and management attention from adopting best quality practices to merely meeting regulatory compliance requirements.

It’s surprising to note a lower than anticipated investment in automation and digital technologies. Aren’t these technologies crucial for improving quality and process control?

Then there’s the shift from the traditional Computer System Validation (CSV) waterfall approach to a more risk-based, product quality, and patient-centric approach in Computer System Assurance (CSA). This encourages critical thinking based on product and process knowledge and quality risk management, moving away from prescriptive documentation-driven approaches.

The FDA determined that the “WHAT” in compliance is constant, but the “HOW” can vary. This challenges the checklist mindset prevalent in most CSV work. Why create documents that don’t address the specific risks?

Supporting this notion, GAMP5 advocates for incremental, iterative, and evolutionary approaches, including agile, for the development of custom applications. Could this be the more efficient path forward?

The keys to success? A robust Quality Management System and well-trained, disciplined teams following well-defined processes supported by tools and automation.

Our interactive webinar will include a comparison of the agile and waterfall methodologies, along with the pros and cons of each. Understanding the strengths and limitations of each approach is critical.

Remember, there may not be one size that fits all. It’s important to understand what needs to be considered when making such a determination.

Delve into the depths of FDA compliance trends and strategies!

Enroll Now!

Data is at the heart of FDA’s work as a science-based agency. We’re witnessing rapid increases in the amount and complexity of data that informs the FDA’s regulatory decision-making and public health mission. But how is this data truly being utilized?

As part of the Case for Quality program, the US FDA Center for Devices and Radiological Health noted an intriguing trend: an excessive focus by industry on compliance rather than quality.

This focus might be diverting resources and management attention from adopting best quality practices to merely meeting regulatory compliance requirements.

It’s surprising to note a lower than anticipated investment in automation and digital technologies. Aren’t these technologies crucial for improving quality and process control?

Then there’s the shift from the traditional Computer System Validation (CSV) waterfall approach to a more risk-based, product quality, and patient-centric approach in Computer System Assurance (CSA). This encourages critical thinking based on product and process knowledge and quality risk management, moving away from prescriptive documentation-driven approaches.

The FDA determined that the “WHAT” in compliance is constant, but the “HOW” can vary. This challenges the checklist mindset prevalent in most CSV work. Why create documents that don’t address the specific risks?

Supporting this notion, GAMP5 advocates for incremental, iterative, and evolutionary approaches, including agile, for the development of custom applications. Could this be the more efficient path forward?

The keys to success? A robust Quality Management System and well-trained, disciplined teams following well-defined processes supported by tools and automation.

Our interactive webinar will include a comparison of the agile and waterfall methodologies, along with the pros and cons of each. Understanding the strengths and limitations of each approach is critical.

Remember, there may not be one size that fits all. It’s important to understand what needs to be considered when making such a determination.

Delve into the depths of FDA compliance trends and strategies!

Enroll Now!

Unlock the Power of Data Integrity and Governance – The FDA is ramping up its focus on data integrity and governance.

• As manufacturers grapple with GMPs and compliance, the FDA expects thorough risk assessments for validation and ongoing maintenance of systems. This isn’t just a regulatory requirement; it’s your pathway to maintaining robust, secure systems that stand the test of time.
• Embrace the Tech Revolution for Business Success 💡 – Advancements in technology aren’t just changing the game; they’re reshaping the playing field. Organizations today face a more chaotic and complex environment, catering to well-informed patients and customers with sky-high expectations. To stay ahead, your work practices and tools must evolve. It’s not just about keeping up; it’s about leading the way in your industry.
• Rethink Software Development and Validation 🚀 – In a world of constant change, the approach to software development, validation, and maintenance through a product’s life cycle demands careful consideration. This isn’t just about compliance; it’s about being agile and responsive to evolving needs.

What You’ll Learn:

1. Transform Your CSV Approach – Dive into modernizing the System Development Life Cycle (SDLC) for Computer System Validation (CSV). Discover how automated testing tools can lead to continuous validation of software products. This isn’t just about keeping pace; it’s about setting the pace.
2. Adapt Agile Methodologies for Robust Validation – Learn how the agile software development methodology can be tailored for validation, offering a more dynamic and efficient approach.
3. Master the Critical Aspects of CSV – Get to grips with the crucial elements of CSV and learn how to apply them in a modern, technologically advanced setting.

Be part of a movement that’s shaping the future of technology in healthcare. Transform your practices, meet regulatory standards, and exceed customer expectations.

Join Now!

Unlock the Power of Data Integrity and Governance – The FDA is ramping up its focus on data integrity and governance.

• As manufacturers grapple with GMPs and compliance, the FDA expects thorough risk assessments for validation and ongoing maintenance of systems. This isn’t just a regulatory requirement; it’s your pathway to maintaining robust, secure systems that stand the test of time.
• Embrace the Tech Revolution for Business Success 💡 – Advancements in technology aren’t just changing the game; they’re reshaping the playing field. Organizations today face a more chaotic and complex environment, catering to well-informed patients and customers with sky-high expectations. To stay ahead, your work practices and tools must evolve. It’s not just about keeping up; it’s about leading the way in your industry.
• Rethink Software Development and Validation 🚀 – In a world of constant change, the approach to software development, validation, and maintenance through a product’s life cycle demands careful consideration. This isn’t just about compliance; it’s about being agile and responsive to evolving needs.

What You’ll Learn:

1. Transform Your CSV Approach – Dive into modernizing the System Development Life Cycle (SDLC) for Computer System Validation (CSV). Discover how automated testing tools can lead to continuous validation of software products. This isn’t just about keeping pace; it’s about setting the pace.
2. Adapt Agile Methodologies for Robust Validation – Learn how the agile software development methodology can be tailored for validation, offering a more dynamic and efficient approach.
3. Master the Critical Aspects of CSV – Get to grips with the crucial elements of CSV and learn how to apply them in a modern, technologically advanced setting.

Be part of a movement that’s shaping the future of technology in healthcare. Transform your practices, meet regulatory standards, and exceed customer expectations.

Join Now!

• Identify “GxP” Systems Easily – Quickly grasp the essentials of “GxP” system identification.
• FDA Tech & Software Insights – Learn the FDA’s current views on technology and its industry impact.
• Modernize CSV Approaches – Update your CSV strategies to align with the latest FDA requirements.
• Agile SDLC Validation – Discover agile SDLC techniques for efficient, ongoing validation.
• Agile vs. Waterfall: The Breakdown – Understand the strengths and weaknesses of these contrasting approaches.
• Cloud Computing & SaaS Mastery – Learn to effectively implement and validate cloud and SaaS solutions.
• Efficient Validation Documentation – Optimize documentation for any approach, enhancing efficiency and effectiveness.
• Cost-Effective System Maintenance – Maintain systems in a validated state more economically.
• Data Integrity in Tech Advances – Ensure data integrity despite rapid technological changes.
• GxP Documentation Compliance – Create FDA-compliant GxP documentation with ease.
• Validation Support Strategies – Develop policies and procedures to support ongoing system maintenance.
• Grasp FDA Regulatory Influences – Stay informed about factors influencing FDA thinking.
• Optimize with Best Practices – Apply industry best practices for validation and compliance based on risk assessment.
• Interactive Q&A Session – Clarify your doubts and enhance your understanding in our 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.

• Identify “GxP” Systems Easily – Quickly grasp the essentials of “GxP” system identification.
• FDA Tech & Software Insights – Learn the FDA’s current views on technology and its industry impact.
• Modernize CSV Approaches – Update your CSV strategies to align with the latest FDA requirements.
• Agile SDLC Validation – Discover agile SDLC techniques for efficient, ongoing validation.
• Agile vs. Waterfall: The Breakdown – Understand the strengths and weaknesses of these contrasting approaches.
• Cloud Computing & SaaS Mastery – Learn to effectively implement and validate cloud and SaaS solutions.
• Efficient Validation Documentation – Optimize documentation for any approach, enhancing efficiency and effectiveness.
• Cost-Effective System Maintenance – Maintain systems in a validated state more economically.
• Data Integrity in Tech Advances – Ensure data integrity despite rapid technological changes.
• GxP Documentation Compliance – Create FDA-compliant GxP documentation with ease.
• Validation Support Strategies – Develop policies and procedures to support ongoing system maintenance.
• Grasp FDA Regulatory Influences – Stay informed about factors influencing FDA thinking.
• Optimize with Best Practices – Apply industry best practices for validation and compliance based on risk assessment.
• Interactive Q&A Session – Clarify your doubts and enhance your understanding in our 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.

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