Audit Trail Excellence: Mastering Data Integrity & Compliance under FDA 21 CFR Part 11
Secure Your Compliance: Navigate, Validate, and Master Audit Trails for Unwavering Data Integrity!
Instructor :
Carolyn Troiano
Webinar ID:
10297
Date: NOV 20, 2024 (WED)
Start Time: 9 AM PT - 12 PM PT
Duration: 3 Hrs.
What you will learn
- Understanding GxP Systems Ensures Quality And Safety
- Overview Of CSV Grounded In FDA Requirements
- SDLC Methodology Emphasizes Planning To Maintenance
- Documenting Validation Efforts: From Design To Operation
- Strategies For Continuous System Compliance Maintenance
- Assuring GxP Work Data Integrity And …
- Understanding GxP Systems Ensures Quality And Safety
- Overview Of CSV Grounded In FDA Requirements
- SDLC Methodology Emphasizes Planning To Maintenance
- Documenting Validation Efforts: From Design To Operation
- Strategies For Continuous System Compliance Maintenance
- Assuring GxP Work Data Integrity And Security
- Audit Trails Critical For Compliance And Risk
- Balancing Technical And Procedural Controls For Validation
- Preparing For FDA Inspections With Best Practices
Course Description
In our 3-hour virtual session, “Audit Trail Mastery: Ensuring FDA 21 CFR Part 11 and Data Integrity Compliance,” participants will dive deep into the critical components of audit trails and their pivotal role in supporting regulatory compliance and safeguarding data integrity within GxP environments.
This comprehensive course is designed to empower attendees with the knowledge and skills to identify GxP systems, understand the Computer System Validation (CSV) approach, and grasp the essentials of the System Development Life Cycle (SDLC) methodology tailored to FDA requirements.
- Explore Best Practices: Learn the ins and outs of documenting CSV efforts, from requirements and design to development, testing, and operational maintenance procedures.
- Validation and Compliance: Understand the mechanisms to maintain systems in a validated state through their lifecycle, ensuring ongoing compliance.
- Risk Management: Discover how to conduct effective risk assessments, developing a validation rationale that aligns with your system’s complexity and criticality.
With a focus on practical application, the session will guide you through establishing policies and procedures that support both the validation process and the maintenance of systems in a validated state, alongside ensuring 21 CFR Part 11 compliance for electronic records and signatures.
Enroll Now!
In our 3-hour virtual session, “Audit Trail Mastery: Ensuring FDA 21 CFR Part 11 and Data Integrity Compliance,” participants will dive deep into the critical components of audit trails and their pivotal role in supporting regulatory compliance and safeguarding data integrity within GxP environments.
This comprehensive course is designed to empower attendees with the knowledge and skills to identify GxP systems, understand the Computer System Validation (CSV) approach, and grasp the essentials of the System Development Life Cycle (SDLC) methodology tailored to FDA requirements.
- Explore Best Practices: Learn the ins and outs of documenting CSV efforts, from requirements and design to development, testing, and operational maintenance procedures.
- Validation and Compliance: Understand the mechanisms to maintain systems in a validated state through their lifecycle, ensuring ongoing compliance.
- Risk Management: Discover how to conduct effective risk assessments, developing a validation rationale that aligns with your system’s complexity and criticality.
With a focus on practical application, the session will guide you through establishing policies and procedures that support both the validation process and the maintenance of systems in a validated state, alongside ensuring 21 CFR Part 11 compliance for electronic records and signatures.
Enroll Now!
Why you should attend
In an era where data integrity is under the microscope and regulatory scrutiny is intensifying, understanding how to implement and maintain robust audit trails has never been more critical. This 3-hour session is a must-attend for professionals seeking to:
- Enhance Compliance: Stay ahead of the curve with up-to-date strategies that meet FDA requirements.
- Mitigate Risks: Equip yourself with the knowledge to identify and mitigate risks associated with data integrity and validation.
- Prepare for Inspections: Learn how to adeptly prepare for FDA inspections or audits, minimizing the potential for non-compliance findings.
Why now? With the FDA’s increasing emphasis on digital health and the use of advanced technologies in the life sciences industry, ensuring that your systems are validated and your data integrity is uncompromised is paramount.
Attendees will leave with:
- A thorough understanding of audit trail requirements and their significance in GxP regulated environments.
- The ability to assess vendor compliance, ensuring their products and services meet your stringent quality standards.
- Insights into industry best practices and how to apply a risk-based approach to validation and compliance, optimizing your processes for maximum efficiency and reliability.
Join us to elevate your expertise and confidence in navigating the complexities of audit trails, CSV, and regulatory compliance. Secure your compliance future today!
This training is a crucial step in ensuring that your practices not only meet current standards but are poised to adapt to future regulations and technological advancements, safeguarding your data’s integrity and your organization’s reputation.
Enroll Now!
In an era where data integrity is under the microscope and regulatory scrutiny is intensifying, understanding how to implement and maintain robust audit trails has never been more critical. This 3-hour session is a must-attend for professionals seeking to:
- Enhance Compliance: Stay ahead of the curve with up-to-date strategies that meet FDA requirements.
- Mitigate Risks: Equip yourself with the knowledge to identify and mitigate risks associated with data integrity and validation.
- Prepare for Inspections: Learn how to adeptly prepare for FDA inspections or audits, minimizing the potential for non-compliance findings.
Why now? With the FDA’s increasing emphasis on digital health and the use of advanced technologies in the life sciences industry, ensuring that your systems are validated and your data integrity is uncompromised is paramount.
Attendees will leave with:
- A thorough understanding of audit trail requirements and their significance in GxP regulated environments.
- The ability to assess vendor compliance, ensuring their products and services meet your stringent quality standards.
- Insights into industry best practices and how to apply a risk-based approach to validation and compliance, optimizing your processes for maximum efficiency and reliability.
Join us to elevate your expertise and confidence in navigating the complexities of audit trails, CSV, and regulatory compliance. Secure your compliance future today!
This training is a crucial step in ensuring that your practices not only meet current standards but are poised to adapt to future regulations and technological advancements, safeguarding your data’s integrity and your organization’s reputation.
Enroll Now!
Areas Covered
Introduction and Foundations
- Understanding “GxP” Systems: Identifying systems under GxP regulation and their significance in ensuring product quality and safety.
- Overview of Computer System Validation (CSV): Discussing the CSV approach grounded in FDA requirements to guarantee systems perform consistently as intended.
- System Development Life Cycle (SDLC) Methodology: Exploring the SDLC approach to validation, emphasizing stages from planning to deployment and maintenance.
Documentation and Data Integrity
- Best Practices for Documenting Validation Efforts: Detailed walkthrough of documenting requirements, design, development, testing, and operational maintenance procedures.
- Maintaining Systems in a Validated State: Strategies for continuous compliance throughout the system’s life cycle.
- Assuring Data Integrity for GxP Work: Techniques to maintain and assure the integrity and security of data.
Audit Trails and Compliance
- Significance and Implementation of Audit Trails: Understanding the critical role of audit trails in compliance and the potential risks of inadequate implementation.
- Balancing Technical and Procedural Controls: Approaches to employ procedural controls in scenarios where technical solutions are not feasible.
- Policies and Procedures for Validation Support: Developing robust policies and procedures that uphold validation efforts and system maintenance.
Regulatory Compliance and Risk Management
- 21 CFR Part 11 Compliance Essentials: Key components for compliance with electronic records and signatures, including recent updates.
- Navigating Regulatory Influences: Insights into how regulatory trends shape FDA’s current stance and expectations.
- Risk Assessment for Computer Systems: Framework for conducting comprehensive risk assessments, forming the foundation for validation rationale.
Vendor Management and Inspection Preparedness
- Preparing for FDA Inspections and Audits: Best practices for audit readiness, focusing on GxP computer systems.
- Conducting Effective Vendor Audits: Essential for ensuring vendors meet compliance standards and deliver quality services and products.
- Industry Best Practices for Validation and Compliance: Leveraging risk-based approaches to validation and compliance to ensure optimal data integrity across the data life cycle.
Interactive and Closing Segments
- Interactive Q&A Session: Engaging participants to address specific questions, clarifications, and real-world application discussions.
- Wrap-Up and Key Takeaways: Summarizing critical points, emphasizing actionable strategies for participants to implement in their validation and compliance efforts.
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
Introduction and Foundations
- Understanding “GxP” Systems: Identifying systems under GxP regulation and their significance in ensuring product quality and safety.
- Overview of Computer System Validation (CSV): Discussing the CSV approach grounded in FDA requirements to guarantee systems perform consistently as intended.
- System Development Life Cycle (SDLC) Methodology: Exploring the SDLC approach to validation, emphasizing stages from planning to deployment and maintenance.
Documentation and Data Integrity
- Best Practices for Documenting Validation Efforts: Detailed walkthrough of documenting requirements, design, development, testing, and operational maintenance procedures.
- Maintaining Systems in a Validated State: Strategies for continuous compliance throughout the system’s life cycle.
- Assuring Data Integrity for GxP Work: Techniques to maintain and assure the integrity and security of data.
Audit Trails and Compliance
- Significance and Implementation of Audit Trails: Understanding the critical role of audit trails in compliance and the potential risks of inadequate implementation.
- Balancing Technical and Procedural Controls: Approaches to employ procedural controls in scenarios where technical solutions are not feasible.
- Policies and Procedures for Validation Support: Developing robust policies and procedures that uphold validation efforts and system maintenance.
Regulatory Compliance and Risk Management
- 21 CFR Part 11 Compliance Essentials: Key components for compliance with electronic records and signatures, including recent updates.
- Navigating Regulatory Influences: Insights into how regulatory trends shape FDA’s current stance and expectations.
- Risk Assessment for Computer Systems: Framework for conducting comprehensive risk assessments, forming the foundation for validation rationale.
Vendor Management and Inspection Preparedness
- Preparing for FDA Inspections and Audits: Best practices for audit readiness, focusing on GxP computer systems.
- Conducting Effective Vendor Audits: Essential for ensuring vendors meet compliance standards and deliver quality services and products.
- Industry Best Practices for Validation and Compliance: Leveraging risk-based approaches to validation and compliance to ensure optimal data integrity across the data life cycle.
Interactive and Closing Segments
- Interactive Q&A Session: Engaging participants to address specific questions, clarifications, and real-world application discussions.
- Wrap-Up and Key Takeaways: Summarizing critical points, emphasizing actionable strategies for participants to implement in their validation and compliance efforts.
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!
Ideal for professionals tasked with leading or participating in the validation of computer systems regulated by the FDA.
- 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!
Ideal for professionals tasked with leading or participating in the validation of computer systems regulated by the FDA.
- 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.
