Master FDA Compliance: 4-Hour Virtual Training on CSV, 21 CFR Part 11, and Risk-Based FDA Audits

Are You Ready for FDA Audits? Learn the Risk-Based Approach to 21 CFR Part 11 !

Instructor :
Carolyn Troiano

Webinar ID:
10403

Date: NOV 06, 2024 (WED)

Start Time: 9 AM PT - 1 PM PT

Duration: 4 Hrs.

What you will learn

    • 21 CFR Part 11 Compliance: Understand Essential Requirements for Compliance.
    • Regulatory Updates And Trends: Explore Recent Changes Affecting CSV Compliance.
    • Data Governance And Integrity: Learn About FDA’s 2018 Guidance.
    • Industry Compliance Best Practices: Discover Top Standards in System Validation.
    • Streamlining FDA Compliance: Implement Cost-Effective and Simplified Compliance Strategies.
    • Risk Management Frameworks: Develop Proactive Approaches for CSV Risk Management.
    • SDLC Methodology And Best Practices: Enhance Validation Through SDLC Implementation.
    • Effective Documentation: Master Maintaining And ….
    • 21 CFR Part 11 Compliance: Understand Essential Requirements for Compliance.
    • Regulatory Updates And Trends: Explore Recent Changes Affecting CSV Compliance.
    • Data Governance And Integrity: Learn About FDA’s 2018 Guidance.
    • Industry Compliance Best Practices: Discover Top Standards in System Validation.
    • Streamlining FDA Compliance: Implement Cost-Effective and Simplified Compliance Strategies.
    • Risk Management Frameworks: Develop Proactive Approaches for CSV Risk Management.
    • SDLC Methodology And Best Practices: Enhance Validation Through SDLC Implementation.
    • Effective Documentation: Master Maintaining And Documenting Validated Systems.
    • Vendor Audit Essentials: Conduct Thorough Audits for Vendor Compliance Assurance.

Course Description

“Did You Know? In 1997, the FDA revolutionized how we handle Electronic Records and Signatures (ER/ES) with guidelines through 21 CFR Part 11.”

But how does this impact systems in an FDA-regulated environment?

Shift to Self-Regulation: By the early 2000s, the FDA shifted its approach, acknowledging the impracticality of inspecting every computer system in every regulated company. Instead, they placed the responsibility on the industry. Now, each company must assess their computer systems using a risk-based approach. But what factors determine this?

Key Components of Risk-Based Validation:

    • System Size and Complexity
    • Business Criticality
    • GAMP 5 Category
    • Risk Rating

How do these components determine the scope and robustness of testing needed to ensure data integrity and product safety?

Recently, the FDA has intensified its focus on data integrity during system validation inspections and audits. This is crucial for compliance, as it encompasses all systems that impact products, including databases, documents, spreadsheets, and multimedia files. Are you effectively managing their integrity throughout their life cycle?

This course dives deep into the risk-based approach to CSV, ensuring your systems not only comply with FDA standards but also operate efficiently.

You’ll gain the tools needed to navigate the regulatory landscape with confidence, utilizing real-world examples, case studies, and best practices to ensure compliance and data integrity.

Enroll Now to master the latest in CSV, 21 CFR Part 11, and FDA compliance.

Register Now!

“Did You Know? In 1997, the FDA revolutionized how we handle Electronic Records and Signatures (ER/ES) with guidelines through 21 CFR Part 11.”

But how does this impact systems in an FDA-regulated environment?

Shift to Self-Regulation: By the early 2000s, the FDA shifted its approach, acknowledging the impracticality of inspecting every computer system in every regulated company. Instead, they placed the responsibility on the industry. Now, each company must assess their computer systems using a risk-based approach. But what factors determine this?

Key Components of Risk-Based Validation:

    • System Size and Complexity
    • Business Criticality
    • GAMP 5 Category
    • Risk Rating

How do these components determine the scope and robustness of testing needed to ensure data integrity and product safety?

Recently, the FDA has intensified its focus on data integrity during system validation inspections and audits. This is crucial for compliance, as it encompasses all systems that impact products, including databases, documents, spreadsheets, and multimedia files. Are you effectively managing their integrity throughout their life cycle?

This course dives deep into the risk-based approach to CSV, ensuring your systems not only comply with FDA standards but also operate efficiently.

You’ll gain the tools needed to navigate the regulatory landscape with confidence, utilizing real-world examples, case studies, and best practices to ensure compliance and data integrity.

Enroll Now to master the latest in CSV, 21 CFR Part 11, and FDA compliance.

Register Now!

Why you should attend

    • Are you confident in your ability to navigate and implement a risk-based approach to CSV that meets FDA regulations?
    • How comfortable are you with the requirements of 21 CFR Part 11, especially when it comes to electronic records and signatures?
    • Do you feel equipped to identify, assess, and mitigate risks in your CSV processes to ensure FDA compliance?

This course is meticulously designed to unravel the complexities of risk management within CSV, ensuring that your systems are not only compliant but also optimized for peak performance.

Join this Interactive Course to:

    • Ensure FDA Compliance: Get expert guidance to make sure your computerized systems are both FDA-compliant and risk-optimized.
    • Master the Risk-Based Approach: Enhance efficiency and effectiveness in your projects by mastering the risk-based approach to CSV.
    • Understand 21 CFR Part 11: Gain an in-depth understanding of 21 CFR Part 11 regulations, which are crucial for managing electronic records and signatures.
    • Mitigate Risks Effectively: Learn proven strategies and best practices to effectively mitigate risks, reducing the likelihood of non-compliance and system failures.
    • Upgrade Your Skills: Ideal for professionals looking to upgrade their skills and for those responsible for overseeing the validation and compliance of computerized systems.

By attending, you’ll delve into real-world examples, case studies, and industry best practices, providing you with the tools to confidently navigate the regulatory landscape. Ensure your systems meet FDA standards while operating efficiently and effectively.

Enroll Now to take the next step in mastering CSV, 21 CFR Part 11, and FDA compliance!

Join Now!

    • Are you confident in your ability to navigate and implement a risk-based approach to CSV that meets FDA regulations?
    • How comfortable are you with the requirements of 21 CFR Part 11, especially when it comes to electronic records and signatures?
    • Do you feel equipped to identify, assess, and mitigate risks in your CSV processes to ensure FDA compliance?

This course is meticulously designed to unravel the complexities of risk management within CSV, ensuring that your systems are not only compliant but also optimized for peak performance.

Join this Interactive Course to:

    • Ensure FDA Compliance: Get expert guidance to make sure your computerized systems are both FDA-compliant and risk-optimized.
    • Master the Risk-Based Approach: Enhance efficiency and effectiveness in your projects by mastering the risk-based approach to CSV.
    • Understand 21 CFR Part 11: Gain an in-depth understanding of 21 CFR Part 11 regulations, which are crucial for managing electronic records and signatures.
    • Mitigate Risks Effectively: Learn proven strategies and best practices to effectively mitigate risks, reducing the likelihood of non-compliance and system failures.
    • Upgrade Your Skills: Ideal for professionals looking to upgrade their skills and for those responsible for overseeing the validation and compliance of computerized systems.

By attending, you’ll delve into real-world examples, case studies, and industry best practices, providing you with the tools to confidently navigate the regulatory landscape. Ensure your systems meet FDA standards while operating efficiently and effectively.

Enroll Now to take the next step in mastering CSV, 21 CFR Part 11, and FDA compliance!

Join Now!

Course Agenda

    • 21 CFR Part 11 Compliance: Understand the Essential Compliance Requirements.
    • Regulatory Updates and Future Trends: Discover Recent Regulatory Changes and Future Trends Affecting CSV.
    • Data Governance and Integrity: Unpack the FDA’s 2018 Guidance on These Key Areas.
    • Industry Compliance Best Practices: Explore Top Standards in System Validation.
    • Streamlining FDA Compliance: Learn Cost-Effective and Simplified Compliance Strategies.
    • Risk Management Frameworks: Explore Practical Risk Frameworks for CSV, Encouraging a Proactive Approach.
    • SDLC Methodology: Learn How It Bolsters Computer System Validation.
    • SDLC Best Practices: Discuss Top Industry Practices for the SDLC Methodology.
    • Effective Documentation: Master the Art of Documenting and Maintaining Validated Systems.
    • Vendor Audit Essentials: Learn How to Thoroughly Audit Vendors in Your Supply Chain.
    • Validation Trends: Stay Informed About Evolving Best Practices in Validation.
    • Case Studies and Real-World Examples: Examine Real-World CSV Applications, Highlighting Key Successes and Lessons.

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
    • 21 CFR Part 11 Compliance: Understand the Essential Compliance Requirements.
    • Regulatory Updates and Future Trends: Discover Recent Regulatory Changes and Future Trends Affecting CSV.
    • Data Governance and Integrity: Unpack the FDA’s 2018 Guidance on These Key Areas.
    • Industry Compliance Best Practices: Explore Top Standards in System Validation.
    • Streamlining FDA Compliance: Learn Cost-Effective and Simplified Compliance Strategies.
    • Risk Management Frameworks: Explore Practical Risk Frameworks for CSV, Encouraging a Proactive Approach.
    • SDLC Methodology: Learn How It Bolsters Computer System Validation.
    • SDLC Best Practices: Discuss Top Industry Practices for the SDLC Methodology.
    • Effective Documentation: Master the Art of Documenting and Maintaining Validated Systems.
    • Vendor Audit Essentials: Learn How to Thoroughly Audit Vendors in Your Supply Chain.
    • Validation Trends: Stay Informed About Evolving Best Practices in Validation.
    • Case Studies and Real-World Examples: Examine Real-World CSV Applications, Highlighting Key Successes and Lessons.

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 Manager
    • Regulatory Affairs Specialist
    • Compliance Officer
    • Validation Engineer
    • Quality Control Analyst
    • IT Manager (in Pharmaceutical or Biotech Industry)
    • Data Governance Specialist
    • Computer System Validation (CSV) Specialist
    • Clinical Data Manager
    • Pharmaceutical Quality Systems Manager
    • Risk Management Officer
    • FDA Regulatory Consultant
    • Clinical Research Coordinator
    • Pharmacovigilance Associate
    • Biotechnology Compliance Analyst

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

    • Quality Assurance Manager
    • Regulatory Affairs Specialist
    • Compliance Officer
    • Validation Engineer
    • Quality Control Analyst
    • IT Manager (in Pharmaceutical or Biotech Industry)
    • Data Governance Specialist
    • Computer System Validation (CSV) Specialist
    • Clinical Data Manager
    • Pharmaceutical Quality Systems Manager
    • Risk Management Officer
    • FDA Regulatory Consultant
    • Clinical Research Coordinator
    • Pharmacovigilance Associate
    • Biotechnology Compliance Analyst

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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