Evolving Audit Trails: Mastering Data Integrity and FDA 21 CFR Part 11 Compliance
Empower Your Compliance Journey: From Basics to Best Practices!
Instructor :
Carolyn Troiano
Webinar ID:
10058
Date: FEB 19, 2025 (WED)
Start Time: 10 AM PT - 11:30 AM PT
Duration: 90 Mins.
What you will learn
- Explore FDA-Aligned CSV Methodology
- Master SDLC Approach for Validation
- Learn Risk Assessment for Validation Strategy
- Pinpoint Crucial GxP Systems for Compliance
- Ensure 21 CFR Part 11 Electronic Records Compliance
- Document Validation Efforts: Best …
- Explore FDA-Aligned CSV Methodology
- Master SDLC Approach for Validation
- Learn Risk Assessment for Validation Strategy
- Pinpoint Crucial GxP Systems for Compliance
- Ensure 21 CFR Part 11 Electronic Records Compliance
- Document Validation Efforts: Best Practices
- Understand Audit Trails’ Role and Risks
- Safeguard Data Integrity for GxP
- Strategies to Maintain Systems in Validated States
- Prepare Effectively for FDA GxP Inspections
Course Description
In this engaging and informative webinar, we delve into the critical importance of audit trails for ensuring data integrity and compliance with FDA 21 CFR Part 11.
With a focus on recent industry citations, we uncover the pivotal role of audit trails in maintaining the sanctity of database records—ensuring not a single original record is obscured or destroyed prematurely.
Key Highlights:
- Understanding Audit Trails: Learn how audit trails serve as a protective shield for database records, logging every update with comprehensive details including the modification’s date, time, executor, and rationale.
- Compliance Challenges Unveiled: Discover the common pitfalls companies face in aligning with Part 11 and data integrity requirements. From deactivated audit trails without documentation to legacy systems lacking this crucial feature, we explore the spectrum of compliance risks.
- Strategic Approaches: Immerse yourself in best practices and strategic methodologies for evaluating computer systems in FDA-regulated activities. Understand the impact of potential failures on data integrity, quality processes, and consumer safety.
- SDLC and Risk Assessment: Navigate through the System Development Life Cycle (SDLC) approach, emphasizing risk assessment and validation to fortify your compliance strategy.
- Essential Documentation and Policies: Gain insights into the vital policies, procedures, and documentation essential for unwavering compliance, and learn how to prepare for an FDA inspection with confidence.
- Vendor Auditing Importance: Unravel the importance of auditing vendors for computer system components, ensuring every aspect of your system upholds the highest standards of integrity and compliance.
- Leveraging Industry Best Practices: Conclude with a comprehensive overview of industry best practices focused on data integrity and risk assessment, empowering your GxP work with actionable insights and strategies.
Join us to empower your journey from understanding the basics to mastering best practices in audit trail management, data integrity, and FDA 21 CFR Part 11 compliance.
Elevate your compliance strategy and ensure your organization stands resilient in the face of evolving regulatory landscapes.
Enroll Now!
In this engaging and informative webinar, we delve into the critical importance of audit trails for ensuring data integrity and compliance with FDA 21 CFR Part 11.
With a focus on recent industry citations, we uncover the pivotal role of audit trails in maintaining the sanctity of database records—ensuring not a single original record is obscured or destroyed prematurely.
Key Highlights:
- Understanding Audit Trails: Learn how audit trails serve as a protective shield for database records, logging every update with comprehensive details including the modification’s date, time, executor, and rationale.
- Compliance Challenges Unveiled: Discover the common pitfalls companies face in aligning with Part 11 and data integrity requirements. From deactivated audit trails without documentation to legacy systems lacking this crucial feature, we explore the spectrum of compliance risks.
- Strategic Approaches: Immerse yourself in best practices and strategic methodologies for evaluating computer systems in FDA-regulated activities. Understand the impact of potential failures on data integrity, quality processes, and consumer safety.
- SDLC and Risk Assessment: Navigate through the System Development Life Cycle (SDLC) approach, emphasizing risk assessment and validation to fortify your compliance strategy.
- Essential Documentation and Policies: Gain insights into the vital policies, procedures, and documentation essential for unwavering compliance, and learn how to prepare for an FDA inspection with confidence.
- Vendor Auditing Importance: Unravel the importance of auditing vendors for computer system components, ensuring every aspect of your system upholds the highest standards of integrity and compliance.
- Leveraging Industry Best Practices: Conclude with a comprehensive overview of industry best practices focused on data integrity and risk assessment, empowering your GxP work with actionable insights and strategies.
Join us to empower your journey from understanding the basics to mastering best practices in audit trail management, data integrity, and FDA 21 CFR Part 11 compliance.
Elevate your compliance strategy and ensure your organization stands resilient in the face of evolving regulatory landscapes.
Enroll Now!
Why you should attend
Maximize Your Compliance Strategy with Our Essential Webinar.
Key Learning Outcomes:
- Audit Trails & Compliance: Gain a deep understanding of the critical role audit trails play in ensuring compliance with FDA 21 CFR Part 11 guidelines for electronic records and signatures, plus data integrity.
- Legacy Systems Solutions: Discover strategies for managing electronic records in legacy systems that lack audit trails, ensuring your system remains compliant.
- Vendor Solutions for Data Traceability: Learn about the solutions vendors can provide to achieve complete traceability of data, a key requirement for compliance.
Navigating FDA Expectations:
- 21 CFR Part 11 and Data Integrity: Receive guidance on meeting FDA expectations for 21 CFR Part 11 and data integrity compliance, including practical tips to streamline validation activities.
- Preparation for FDA Inspections: Understand how internal inspections led by Quality teams can identify and remediate data integrity gaps, ensuring your system is inspection-ready.
Join Now!
Maximize Your Compliance Strategy with Our Essential Webinar.
Key Learning Outcomes:
- Audit Trails & Compliance: Gain a deep understanding of the critical role audit trails play in ensuring compliance with FDA 21 CFR Part 11 guidelines for electronic records and signatures, plus data integrity.
- Legacy Systems Solutions: Discover strategies for managing electronic records in legacy systems that lack audit trails, ensuring your system remains compliant.
- Vendor Solutions for Data Traceability: Learn about the solutions vendors can provide to achieve complete traceability of data, a key requirement for compliance.
Navigating FDA Expectations:
- 21 CFR Part 11 and Data Integrity: Receive guidance on meeting FDA expectations for 21 CFR Part 11 and data integrity compliance, including practical tips to streamline validation activities.
- Preparation for FDA Inspections: Understand how internal inspections led by Quality teams can identify and remediate data integrity gaps, ensuring your system is inspection-ready.
Join Now!
Course Agenda
- Identifying GxP Systems: Acquire skills to pinpoint systems crucial for Good Practice (GxP) compliance.
- CSV Approach: Explore the Computer System Validation (CSV) methodology aligned with FDA guidelines.
- SDLC Validation: Dive into the System Development Life Cycle (SDLC) approach for thorough validation.
- Risk Assessment for Validation Rationale: Learn to perform risk assessments on computer systems to inform your validation strategy.
- System Assessment for Validation Planning: Evaluate system attributes such as size, complexity, and risk for a comprehensive validation rationale.
- 21 CFR Part 11 Compliance: Get to know the crucial elements of compliance with 21 CFR Part 11 for electronic records and signatures.
- Validation Documentation Best Practices: Master the art of documenting validation efforts effectively, covering all phases from requirements to operational maintenance.
- Audit Trail Significance: Grasp the importance of including audit trails in systems and the risks of omission.
- Data Integrity Assurance: Understand methods to safeguard the integrity of GxP-supportive data.
- GxP Documentation Compliance: Discuss the essentials of GxP documentation that meets FDA standards.
- Procedural vs. Technical Controls: Learn how procedural controls can substitute for technical limitations.
- Maintaining Validated States: Learn strategies to keep systems validated throughout their lifecycle.
- Validation Support Procedures: Uncover the necessary policies and procedures for supporting validation and maintenance of validated states.
- Regulatory Influences and FDA Insights: Stay informed about the regulatory trends shaping FDA’s current perspectives.
- FDA Inspection Preparation: Gain insights on effective preparation for FDA audits of GxP computer systems.
- Vendor Audit Importance: Recognize the significance of conducting detailed vendor audits for quality assurance.
- Industry Best Practices: Discover industry-leading practices for optimizing validation and compliance efforts based on risk assessment, ensuring data integrity across the data lifecycle.
- Interactive Q&A Session: Opportunity to clarify doubts and gain further insights directly from 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
- Identifying GxP Systems: Acquire skills to pinpoint systems crucial for Good Practice (GxP) compliance.
- CSV Approach: Explore the Computer System Validation (CSV) methodology aligned with FDA guidelines.
- SDLC Validation: Dive into the System Development Life Cycle (SDLC) approach for thorough validation.
- Risk Assessment for Validation Rationale: Learn to perform risk assessments on computer systems to inform your validation strategy.
- System Assessment for Validation Planning: Evaluate system attributes such as size, complexity, and risk for a comprehensive validation rationale.
- 21 CFR Part 11 Compliance: Get to know the crucial elements of compliance with 21 CFR Part 11 for electronic records and signatures.
- Validation Documentation Best Practices: Master the art of documenting validation efforts effectively, covering all phases from requirements to operational maintenance.
- Audit Trail Significance: Grasp the importance of including audit trails in systems and the risks of omission.
- Data Integrity Assurance: Understand methods to safeguard the integrity of GxP-supportive data.
- GxP Documentation Compliance: Discuss the essentials of GxP documentation that meets FDA standards.
- Procedural vs. Technical Controls: Learn how procedural controls can substitute for technical limitations.
- Maintaining Validated States: Learn strategies to keep systems validated throughout their lifecycle.
- Validation Support Procedures: Uncover the necessary policies and procedures for supporting validation and maintenance of validated states.
- Regulatory Influences and FDA Insights: Stay informed about the regulatory trends shaping FDA’s current perspectives.
- FDA Inspection Preparation: Gain insights on effective preparation for FDA audits of GxP computer systems.
- Vendor Audit Importance: Recognize the significance of conducting detailed vendor audits for quality assurance.
- Industry Best Practices: Discover industry-leading practices for optimizing validation and compliance efforts based on risk assessment, ensuring data integrity across the data lifecycle.
- Interactive Q&A Session: Opportunity to clarify doubts and gain further insights directly from 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
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 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 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.
