Navigating FDA Compliance in the Era of Cloud, COTS, and SaaS: A 2024 Guide
Are Your Systems Ready for the FDA’s Tech-Forward Compliance?
Instructor :
Carolyn Troiano
Webinar ID:
11412
Date: DEC 12, 2024 (THU)
Start Time: 10 AM PT - 11:30 AM PT
Duration: 90 Mins.
What you will learn
- FDA Compliance Trends And Enforcement
- GxP Systems And Computer System Validation (CSV)
- Computer Software Assurance (CSA) And Agile Methodologies
- Automated Testing For Validation
- Cloud Services: COTS, SaaS, IaaS ….
- FDA Compliance Trends And Enforcement
- GxP Systems And Computer System Validation (CSV)
- Computer Software Assurance (CSA) And Agile Methodologies
- Automated Testing For Validation
- Cloud Services: COTS, SaaS, IaaS, PaaS
- Installation Qualification (IQ) For Cloud And SaaS Systems
- Maintaining A Validated System
- Validation Policies, Procedures, And Industry Best Practices
- Optimizing Experience With Cloud Service Providers
Course Description
In the rapidly evolving landscape of Cloud, COTS, and SaaS systems, companies face pressing challenges in maintaining FDA validation compliance. This course answers key questions and provides actionable strategies to ensure your organization remains compliant while leveraging modern technologies.
Key Questions Addressed:
- Installation Qualification (IQ): How can we perform an IQ when the server is fully controlled by a vendor?
- Vendor Management: How do we ensure that the vendor can manage security, backups, disaster recovery, and data integrity?
- Change Control: What about change control processes?
- 21 CFR Part 11 Compliance: How will we handle compliance with FDA’s electronic records and electronic signatures guidance?
- Validation Documentation: Won’t our validation documentation be lacking?
Course Highlights:
- Cloud Service Models: Learn how multi-tenant and single-tenant cloud solutions impact compliance, security, and cost.
- Service Level Agreements (SLAs): Understand how contracts and SLAs can mitigate risks and hold vendors accountable.
- Risk Management: Discover how to balance risk tolerance, budget constraints, and the need for state-of-the-art technology.
- FDA’s Evolving Perspective: Explore how the FDA is shifting towards newer technologies to support innovation without compromising quality.
- Computer System Assurance (CSA): Delve into the FDA’s risk-based, product quality, and patient-centric approach to Computer System Assurance (CSA) versus the traditional Computer System Validation (CSV) approach.
- GAMP®5 and Agile Testing: Gain insights into how GAMP®5 supports incremental, iterative, and agile methodologies for developing custom applications.
This course is essential for anyone involved in ensuring FDA compliance in today’s technology-driven environment. You’ll leave with a clear understanding of how to leverage modern systems while meeting regulatory requirements.
Join Now!
In the rapidly evolving landscape of Cloud, COTS, and SaaS systems, companies face pressing challenges in maintaining FDA validation compliance. This course answers key questions and provides actionable strategies to ensure your organization remains compliant while leveraging modern technologies.
Key Questions Addressed:
- Installation Qualification (IQ): How can we perform an IQ when the server is fully controlled by a vendor?
- Vendor Management: How do we ensure that the vendor can manage security, backups, disaster recovery, and data integrity?
- Change Control: What about change control processes?
- 21 CFR Part 11 Compliance: How will we handle compliance with FDA’s electronic records and electronic signatures guidance?
- Validation Documentation: Won’t our validation documentation be lacking?
Course Highlights:
- Cloud Service Models: Learn how multi-tenant and single-tenant cloud solutions impact compliance, security, and cost.
- Service Level Agreements (SLAs): Understand how contracts and SLAs can mitigate risks and hold vendors accountable.
- Risk Management: Discover how to balance risk tolerance, budget constraints, and the need for state-of-the-art technology.
- FDA’s Evolving Perspective: Explore how the FDA is shifting towards newer technologies to support innovation without compromising quality.
- Computer System Assurance (CSA): Delve into the FDA’s risk-based, product quality, and patient-centric approach to Computer System Assurance (CSA) versus the traditional Computer System Validation (CSV) approach.
- GAMP®5 and Agile Testing: Gain insights into how GAMP®5 supports incremental, iterative, and agile methodologies for developing custom applications.
This course is essential for anyone involved in ensuring FDA compliance in today’s technology-driven environment. You’ll leave with a clear understanding of how to leverage modern systems while meeting regulatory requirements.
Join Now!
Why you should attend
In today’s fast-paced, technology-driven world, organizations are being forced to rethink their business models. What were once controlled and orderly environments have become increasingly chaotic and complex, driven by patients and customers who are more informed and have higher expectations than ever before. As a result, work practices and tools must evolve to meet these new challenges.
This webinar is essential for those looking to stay ahead of these changes by understanding the latest methodologies and tools for software development, validation, and system maintenance.
Key Reasons to Attend:
- Understand Methodologies: Gain insights into the agile and waterfall methodologies, learning the pros and cons of each. Recognize that there is no one-size-fits-all solution and understand what factors to consider when choosing the right approach for your organization.
- Explore Technology Models: Delve into COTS, SaaS, IaaS, PaaS, and cloud services to comprehend the benefits and risks associated with each. Learn the best practices for meeting FDA’s requirements for validation, 21 CFR Part 11 compliance, and data integrity.
- Stay Updated on FDA Expectations: Identify the FDA’s current concerns and understand how to ensure your systems meet their expectations. Learn about the FDA’s approach to modernizing technology, and how this modernization benefits both the Agency and the industry.
- Modernize System Development Life Cycle (SDLC): Discover ways to update the System Development Life Cycle (SDLC) approach to Computer System Validation (CSV) using automated testing tools that enable continuous validation. This approach aligns with the agile software development methodology, adaptable for validation purposes.
- Best Practices for Success: Discuss industry best practices for modernizing software validation processes, ensuring compliance while keeping pace with technological advancements.
- Optimize Contracts and SLAs: Learn how to select the optimal technology solution and build contracts and Service Level Agreements (SLAs) that suit your environment and needs.
Attending this webinar will equip you with the knowledge and tools to effectively navigate the complexities of modern technology systems while maintaining compliance with FDA regulations.
Enroll Now!
In today’s fast-paced, technology-driven world, organizations are being forced to rethink their business models. What were once controlled and orderly environments have become increasingly chaotic and complex, driven by patients and customers who are more informed and have higher expectations than ever before. As a result, work practices and tools must evolve to meet these new challenges.
This webinar is essential for those looking to stay ahead of these changes by understanding the latest methodologies and tools for software development, validation, and system maintenance.
Key Reasons to Attend:
- Understand Methodologies: Gain insights into the agile and waterfall methodologies, learning the pros and cons of each. Recognize that there is no one-size-fits-all solution and understand what factors to consider when choosing the right approach for your organization.
- Explore Technology Models: Delve into COTS, SaaS, IaaS, PaaS, and cloud services to comprehend the benefits and risks associated with each. Learn the best practices for meeting FDA’s requirements for validation, 21 CFR Part 11 compliance, and data integrity.
- Stay Updated on FDA Expectations: Identify the FDA’s current concerns and understand how to ensure your systems meet their expectations. Learn about the FDA’s approach to modernizing technology, and how this modernization benefits both the Agency and the industry.
- Modernize System Development Life Cycle (SDLC): Discover ways to update the System Development Life Cycle (SDLC) approach to Computer System Validation (CSV) using automated testing tools that enable continuous validation. This approach aligns with the agile software development methodology, adaptable for validation purposes.
- Best Practices for Success: Discuss industry best practices for modernizing software validation processes, ensuring compliance while keeping pace with technological advancements.
- Optimize Contracts and SLAs: Learn how to select the optimal technology solution and build contracts and Service Level Agreements (SLAs) that suit your environment and needs.
Attending this webinar will equip you with the knowledge and tools to effectively navigate the complexities of modern technology systems while maintaining compliance with FDA regulations.
Enroll Now!
Course Agenda
- FDA Trends in Compliance and Enforcement
- GxP Systems
- Computer System Validation (CSV)
- Computer Software Assurance (CSA)
- Waterfall and Agile Methodologies
- Automated Testing
- Cloud Services
- Computer-Off-the-Shelf (COTS) Software
- Software-as-a-Service (SaaS)
- Infrastructure-as-a-Service (IaaS)
- Platform-as-a-Service (PaaS)
- Approach to Installation Qualification (IQ) for Cloud and SaaS Systems
- Maintaining a Validated System
- Policies and Procedures Related to Validation
- Industry Best Practices
- Optimizing Your Experience with Cloud Service Providers
- 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
- FDA Trends in Compliance and Enforcement
- GxP Systems
- Computer System Validation (CSV)
- Computer Software Assurance (CSA)
- Waterfall and Agile Methodologies
- Automated Testing
- Cloud Services
- Computer-Off-the-Shelf (COTS) Software
- Software-as-a-Service (SaaS)
- Infrastructure-as-a-Service (IaaS)
- Platform-as-a-Service (PaaS)
- Approach to Installation Qualification (IQ) for Cloud and SaaS Systems
- Maintaining a Validated System
- Policies and Procedures Related to Validation
- Industry Best Practices
- Optimizing Your Experience with Cloud Service Providers
- 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
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.
