Instructor :
Carolyn Troiano

Webinar ID:
11136

Navigating 21 CFR Part 11 Compliance: Ensuring Integrity in FDA-Regulated Computer Systems!

In today’s fast-evolving regulatory landscape, particularly in January 2024, understanding and adhering to FDA’s 21 CFR Part 11 is crucial for companies leveraging electronic records and electronic signatures (ER/ES) in their computer systems.

This webinar, led by expert Carolyn Troiano, will dive deep into these critical areas:

• ER/ES Limitations and Security: We’ll discuss the inherent constraints of using ER/ES, such as the disabled print functionality to maintain decision integrity based on electronic, not paper records. This segment emphasizes the importance of robust user identification to ensure electronic signatures authentically represent the individual entering them.
• Password Protocols and Signature Specificity: Adherence to stringent password change rules and maintaining their security is non-negotiable. We’ll also clarify how signatures must unambiguously indicate the signer’s role – whether it’s executing, recording, reviewing, or approving tasks.
• Organizational Policies and Segregation of Duties: We’ll outline the necessity of having clear policies and procedures that not only comply with 21 CFR Part 11 but also provide practical guidance for ER/ES implementation. This includes ensuring proper segregation of duties to avoid conflicts of interest.
• Adapting to Regulatory and Technological Changes: The FDA’s regulatory environment is continuously evolving. We will explore how companies must adapt, especially considering the influx of new technologies. While these advancements aim to streamline operations, they can also introduce complexities in system validation and maintenance, affecting the cost-benefit analysis.
• Lifecycle Management of Validated Systems: Finally, we’ll cover strategies for maintaining systems in a validated state throughout their lifecycle, balancing operational efficiency with regulatory compliance.

Join us for this enlightening session to stay ahead in managing FDA-regulated computer systems effectively and compliantly.

Join Now!

Navigating 21 CFR Part 11 Compliance: Ensuring Integrity in FDA-Regulated Computer Systems!

In today’s fast-evolving regulatory landscape, particularly in January 2024, understanding and adhering to FDA’s 21 CFR Part 11 is crucial for companies leveraging electronic records and electronic signatures (ER/ES) in their computer systems.

This webinar, led by expert Carolyn Troiano, will dive deep into these critical areas:

• ER/ES Limitations and Security: We’ll discuss the inherent constraints of using ER/ES, such as the disabled print functionality to maintain decision integrity based on electronic, not paper records. This segment emphasizes the importance of robust user identification to ensure electronic signatures authentically represent the individual entering them.
• Password Protocols and Signature Specificity: Adherence to stringent password change rules and maintaining their security is non-negotiable. We’ll also clarify how signatures must unambiguously indicate the signer’s role – whether it’s executing, recording, reviewing, or approving tasks.
• Organizational Policies and Segregation of Duties: We’ll outline the necessity of having clear policies and procedures that not only comply with 21 CFR Part 11 but also provide practical guidance for ER/ES implementation. This includes ensuring proper segregation of duties to avoid conflicts of interest.
• Adapting to Regulatory and Technological Changes: The FDA’s regulatory environment is continuously evolving. We will explore how companies must adapt, especially considering the influx of new technologies. While these advancements aim to streamline operations, they can also introduce complexities in system validation and maintenance, affecting the cost-benefit analysis.
• Lifecycle Management of Validated Systems: Finally, we’ll cover strategies for maintaining systems in a validated state throughout their lifecycle, balancing operational efficiency with regulatory compliance.

Join us for this enlightening session to stay ahead in managing FDA-regulated computer systems effectively and compliantly.

Join Now!

This seminar will help you understand in detail the application of FDA’s 21 CFR Part 11 guidance on electronic records/electronic signatures (ER/ES) for computer systems subject to FDA regulations.

This is critical to developing the appropriate validation strategy and achieving the thoroughness required to prove that a system does what it purports to do.

It also ensures that a system is maintained in a validated state throughout its entire life cycle, from conception through retirement.

Enroll Now!

This seminar will help you understand in detail the application of FDA’s 21 CFR Part 11 guidance on electronic records/electronic signatures (ER/ES) for computer systems subject to FDA regulations.

This is critical to developing the appropriate validation strategy and achieving the thoroughness required to prove that a system does what it purports to do.

It also ensures that a system is maintained in a validated state throughout its entire life cycle, from conception through retirement.

Enroll Now!

• Explore 21 CFR Part 11: Learn key compliance requirements for this critical FDA regulation.
• Industry Best Practices: Understand standards for compliance and system validation.
• SDLC Methodology: Discover how SDLC supports computer system validation.
• Implementing SDLC: Learn best practices for effective SDLC application.
• Effective Documentation: Master documenting and maintaining validated systems.
• Compliance Simplified: Strategies to reduce the complexity and cost of FDA compliance.
• Data Governance Insights: Learn about Data Integrity and Governance per FDA’s 2018 guidance.
• Vendor Auditing Essentials: Understand auditing hardware and software vendors.
• Stay Informed: Keep up with validation trends and emerging best practices.
• Q&A

BONUS:

1. PDF copy of the presentation handout for your future reference.
2. Soft copy of the certificate of completion on request.
3. Q&A Session with the Presenter: Get your pressing questions answered verbally, via chat or email

• Explore 21 CFR Part 11: Learn key compliance requirements for this critical FDA regulation.
• Industry Best Practices: Understand standards for compliance and system validation.
• SDLC Methodology: Discover how SDLC supports computer system validation.
• Implementing SDLC: Learn best practices for effective SDLC application.
• Effective Documentation: Master documenting and maintaining validated systems.
• Compliance Simplified: Strategies to reduce the complexity and cost of FDA compliance.
• Data Governance Insights: Learn about Data Integrity and Governance per FDA’s 2018 guidance.
• Vendor Auditing Essentials: Understand auditing hardware and software vendors.
• Stay Informed: Keep up with validation trends and emerging best practices.
• Q&A

BONUS:

1. PDF copy of the presentation handout for your future reference.
2. Soft copy of the certificate of completion on request.
3. Q&A Session with the Presenter: Get your pressing questions answered verbally, via chat or email

The following benefits from watching this. Even better when done as a group!

• 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
• Consultants in the Life Sciences and Tobacco Industries
• Interns working at the companies listed above
• College students attending schools and studying computer system validation, regulatory affairs/matters (related to FDA) or any other discipline that involves adherence to FDA regulatory requirements

The following benefits from watching this. Even better when done as a group!

• 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
• Consultants in the Life Sciences and Tobacco Industries
• Interns working at the companies listed above
• College students attending schools and studying computer system validation, regulatory affairs/matters (related to FDA) or any other discipline that involves adherence to FDA regulatory requirements