FDA Compliance or Bust: Perfecting Documentation for Computer System Validation (CSV)

Master Critical Documentation Skills For a Seamless, Audit-Ready FDA Compliance Journey!

Instructor :
Carolyn Troiano

Webinar ID:
10407

Date: NOV 12, 2024 (TUE)

Start Time: 10 AM PT - 1:00 PM PT

Duration: 3 Hrs.

What you will learn

    • Integrate CSV Within SDLC For FDA Regulatory Compliance
    • Understand Key GxP Principles For Quality And Compliance Assurance
    • Master 21 CFR Part 11 For ER/ES Requirements
    • Implement Effective Data Archival For Security And Compliance
    • Ensure Comprehensive CSV Documentation For End-To-End Compliance
    • Learn Documentation Best Practices To ….
    • Integrate CSV Within SDLC For FDA Regulatory Compliance
    • Understand Key GxP Principles For Quality And Compliance Assurance
    • Master 21 CFR Part 11 For ER/ES Requirements
    • Implement Effective Data Archival For Security And Compliance
    • Ensure Comprehensive CSV Documentation For End-To-End Compliance
    • Learn Documentation Best Practices To Prevent Compliance Risks
    • Participate In Live Q&A To Enhance CSV Understanding

Course Description

Ensure FDA Compliance with Effective Documentation for Computer System Validation (CSV)

Inadequate Computer System Validation (CSV) documentation can expose your organization to critical challenges, including:

    • Regulatory Compliance Risks: Potential fines, legal complications, and operational halts.
    • Audit Failures: Increased chances of failed audits due to incomplete or insufficient documentation.
    • Data Integrity Concerns: Issues surrounding data accuracy, reliability, and trustworthiness.
    • System Development Delays: Slowed development cycles and unclear system requirements.
    • Training Inefficiencies: Reduced productivity and difficulties in effective staff training.

Comprehensive, clear, and compliant CSV documentation is not only beneficial—it’s essential for avoiding these costly pitfalls.

Our 3-hour, expert-led webinar on Computer System Validation (CSV) is designed for professionals in pharmaceuticals, biotechnology, medical devices, and other FDA-regulated industries. You’ll gain practical insights into FDA-compliant documentation practices that support data integrity and system reliability.

With over 30 years of FDA regulation, CSV is critical for comprehensive planning, testing, and managing computer systems to meet FDA standards. This course provides a deep dive into the documentation practices essential for successful CSV.

Key Topics Covered:

    • Electronic Records and Signatures (ER/ES): Learn how to navigate 21 CFR Part 11 guidelines on validating electronic records and signatures in FDA-regulated environments.
    • Risk-Based Assessment: Discover the FDA’s shift to a risk-based approach for system validation, with insights into GAMP 5 categories, system complexity, and risk rating for defining testing scope.
    • Data Integrity (DI): Address escalating data integrity challenges emphasized by the FDA in its 2018 guidelines, underscoring robust DI practices for successful inspections.
    • Validation Lifecycle Management: Explore best practices for maintaining systems in a validated state across their lifecycle, with special focus on change control, audit trails, and keeping validation efforts up-to-date.

By attending this webinar, you’ll ensure your CSV documentation is clear, precise, and compliant, fostering better communication and understanding among all stakeholders involved.

Secure your spot today and stay audit-ready with compliant documentation practices!

Ensure FDA Compliance with Effective Documentation for Computer System Validation (CSV)

Inadequate Computer System Validation (CSV) documentation can expose your organization to critical challenges, including:

    • Regulatory Compliance Risks: Potential fines, legal complications, and operational halts.
    • Audit Failures: Increased chances of failed audits due to incomplete or insufficient documentation.
    • Data Integrity Concerns: Issues surrounding data accuracy, reliability, and trustworthiness.
    • System Development Delays: Slowed development cycles and unclear system requirements.
    • Training Inefficiencies: Reduced productivity and difficulties in effective staff training.

Comprehensive, clear, and compliant CSV documentation is not only beneficial—it’s essential for avoiding these costly pitfalls.

Our 3-hour, expert-led webinar on Computer System Validation (CSV) is designed for professionals in pharmaceuticals, biotechnology, medical devices, and other FDA-regulated industries. You’ll gain practical insights into FDA-compliant documentation practices that support data integrity and system reliability.

With over 30 years of FDA regulation, CSV is critical for comprehensive planning, testing, and managing computer systems to meet FDA standards. This course provides a deep dive into the documentation practices essential for successful CSV.

Key Topics Covered:

    • Electronic Records and Signatures (ER/ES): Learn how to navigate 21 CFR Part 11 guidelines on validating electronic records and signatures in FDA-regulated environments.
    • Risk-Based Assessment: Discover the FDA’s shift to a risk-based approach for system validation, with insights into GAMP 5 categories, system complexity, and risk rating for defining testing scope.
    • Data Integrity (DI): Address escalating data integrity challenges emphasized by the FDA in its 2018 guidelines, underscoring robust DI practices for successful inspections.
    • Validation Lifecycle Management: Explore best practices for maintaining systems in a validated state across their lifecycle, with special focus on change control, audit trails, and keeping validation efforts up-to-date.

By attending this webinar, you’ll ensure your CSV documentation is clear, precise, and compliant, fostering better communication and understanding among all stakeholders involved.

Secure your spot today and stay audit-ready with compliant documentation practices!

Why you should attend

    • Is your documentation strategy strong enough to meet FDA CSV standards?
    • Are you confident your practices align with FDA’s stringent expectations?
    • Do you face ongoing challenges in maintaining compliant, effective validation documentation?

In today’s rapidly evolving regulatory landscape, mastering FDA-approved Good Documentation Practices (GDP) for Computer System Validation (CSV) isn’t just a requirement; it’s a strategic advantage.

Attending this course will provide you with essential insights and up-to-date practices to ensure your computer systems are FDA-compliant, efficient, and ready for audit.

Here’s why this training is critical for professionals in FDA-regulated industries:

    • Stay Ahead of Changing FDA Regulations: With evolving standards, especially around Electronic Records and Signatures (ER/ES) in 21 CFR Part 11, this course prepares you to handle requirements that could otherwise lead to operational disruptions and financial penalties.
    • Gain Mastery in Risk-Based Assessment: The FDA’s shift toward risk-based validation emphasizes the importance of focused, effective validation efforts. You’ll learn how to apply this approach, ensuring your compliance efforts are streamlined and aligned with regulatory expectations.
    • Address Data Integrity (DI) Challenges: With data integrity issues rising in FDA inspections, this course equips you with best practices to safeguard data integrity, a vital component of product safety and public trust.
    • Maintain Validation Efforts in a “Current” State: Avoid the costly mistake of outdated systems by learning to keep documentation and validation efforts continuously compliant—critical for preventing audit failures and ensuring operational excellence.

By attending, you’re not just fulfilling regulatory obligations; you’re enhancing your professional skill set, boosting system reliability, and safeguarding your organization’s reputation.

Turn regulatory challenges into career opportunities and drive growth with advanced CSV practices.

Enroll Now and stay compliant, efficient, and audit-ready!

    • Is your documentation strategy strong enough to meet FDA CSV standards?
    • Are you confident your practices align with FDA’s stringent expectations?
    • Do you face ongoing challenges in maintaining compliant, effective validation documentation?

In today’s rapidly evolving regulatory landscape, mastering FDA-approved Good Documentation Practices (GDP) for Computer System Validation (CSV) isn’t just a requirement; it’s a strategic advantage.

Attending this course will provide you with essential insights and up-to-date practices to ensure your computer systems are FDA-compliant, efficient, and ready for audit.

Here’s why this training is critical for professionals in FDA-regulated industries:

    • Stay Ahead of Changing FDA Regulations: With evolving standards, especially around Electronic Records and Signatures (ER/ES) in 21 CFR Part 11, this course prepares you to handle requirements that could otherwise lead to operational disruptions and financial penalties.
    • Gain Mastery in Risk-Based Assessment: The FDA’s shift toward risk-based validation emphasizes the importance of focused, effective validation efforts. You’ll learn how to apply this approach, ensuring your compliance efforts are streamlined and aligned with regulatory expectations.
    • Address Data Integrity (DI) Challenges: With data integrity issues rising in FDA inspections, this course equips you with best practices to safeguard data integrity, a vital component of product safety and public trust.
    • Maintain Validation Efforts in a “Current” State: Avoid the costly mistake of outdated systems by learning to keep documentation and validation efforts continuously compliant—critical for preventing audit failures and ensuring operational excellence.

By attending, you’re not just fulfilling regulatory obligations; you’re enhancing your professional skill set, boosting system reliability, and safeguarding your organization’s reputation.

Turn regulatory challenges into career opportunities and drive growth with advanced CSV practices.

Enroll Now and stay compliant, efficient, and audit-ready!

Course Agenda

    • CSV and SDLC Methodology: Understand the integration of Computer System Validation (CSV) within the Software Development Life Cycle (SDLC) to ensure alignment with FDA regulatory standards.
    • Overview of “GxP” Practices: Review core principles of Good Manufacturing, Laboratory, and Clinical Practices (GxP), essential for maintaining quality and regulatory compliance.
    • 21 CFR Part 11 Compliance: Gain an in-depth understanding of Electronic Records and Electronic Signatures (ER/ES) requirements under 21 CFR Part 11 for FDA-regulated environments.
    • Effective Data Archival Strategies: Learn best practices for data security, integrity, and compliance in data archiving to meet FDA guidelines.
    • CSV Documentation Requirements: Master the documentation phases—from initial requirements gathering to ongoing maintenance—to ensure FDA compliance throughout the CSV lifecycle.
    • Documentation Best Practices: Discover proven documentation techniques that enhance CSV efforts and help maintain audit-ready records for regulatory approval.
    • Avoiding Common Documentation Errors: Identify examples of non-compliant documentation and learn strategies to prevent common errors that could risk regulatory compliance.
    • Developing Compliance Procedures: Develop standardized procedures that incorporate best practices, ensuring that all FDA-compliant documentation meets regulatory expectations.
    • Importance of GDP Training: Recognize the critical role of Good Documentation Practice (GDP) training in building staff competence and maintaining ongoing compliance.
    • Interactive Q&A Session: Participate in a live Q&A to ask questions, clarify concepts, and deepen your understanding of CSV and compliant documentation practices.

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
    • CSV and SDLC Methodology: Understand the integration of Computer System Validation (CSV) within the Software Development Life Cycle (SDLC) to ensure alignment with FDA regulatory standards.
    • Overview of “GxP” Practices: Review core principles of Good Manufacturing, Laboratory, and Clinical Practices (GxP), essential for maintaining quality and regulatory compliance.
    • 21 CFR Part 11 Compliance: Gain an in-depth understanding of Electronic Records and Electronic Signatures (ER/ES) requirements under 21 CFR Part 11 for FDA-regulated environments.
    • Effective Data Archival Strategies: Learn best practices for data security, integrity, and compliance in data archiving to meet FDA guidelines.
    • CSV Documentation Requirements: Master the documentation phases—from initial requirements gathering to ongoing maintenance—to ensure FDA compliance throughout the CSV lifecycle.
    • Documentation Best Practices: Discover proven documentation techniques that enhance CSV efforts and help maintain audit-ready records for regulatory approval.
    • Avoiding Common Documentation Errors: Identify examples of non-compliant documentation and learn strategies to prevent common errors that could risk regulatory compliance.
    • Developing Compliance Procedures: Develop standardized procedures that incorporate best practices, ensuring that all FDA-compliant documentation meets regulatory expectations.
    • Importance of GDP Training: Recognize the critical role of Good Documentation Practice (GDP) training in building staff competence and maintaining ongoing compliance.
    • Interactive Q&A Session: Participate in a live Q&A to ask questions, clarify concepts, and deepen your understanding of CSV and compliant documentation practices.

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

Who is this course for

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

    • Quality Assurance Managers Focused on Regulatory Compliance
    • Compliance Officers Seeking to Minimize Audit and Compliance Risks
    • Project Managers Overseeing CSV-Related Projects in Regulated Environments
    • IT Leaders Ensuring Data Integrity and System Validation
    • R&D Teams Developing FDA-Regulated Products
    • Training Managers Implementing Compliance-Focused Learning Programs
    • HR Professionals Supporting Regulatory Training Needs
    • Data Integrity Specialists Focused on Reliable Data Practices
    • Operations Managers Committed to Efficient, Compliant Processes

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

    • Quality Assurance Managers Focused on Regulatory Compliance
    • Compliance Officers Seeking to Minimize Audit and Compliance Risks
    • Project Managers Overseeing CSV-Related Projects in Regulated Environments
    • IT Leaders Ensuring Data Integrity and System Validation
    • R&D Teams Developing FDA-Regulated Products
    • Training Managers Implementing Compliance-Focused Learning Programs
    • HR Professionals Supporting Regulatory Training Needs
    • Data Integrity Specialists Focused on Reliable Data Practices
    • Operations Managers Committed to Efficient, Compliant Processes

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 ...

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.

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