Cut Through the Complexity: Simplify 21 CFR Part 11 Compliance for Seamless Computer System Validation

Learn from the Experts: Master 21 CFR Part 11 Compliance and Actionable Strategies in 3 Hours!

Instructor :
Carolyn Troiano

Webinar ID:
11616

Date: MAR 04, 2025 (TUE)

Start Time: 9 AM PT - 12 PM PT

Duration: 3 Hrs.

What will you learn

    • Understanding FDA Oversight And System Development Life Cycle (SDLC)
    • Mastering Computer System Validation And GAMP 5 Software Categorization
    • Achieving 21 CFR Part 11 Electronic Records Compliance
    • Strengthening Security, Access Control, And Managing Audit Trails Effectively
    • Creating Robust Validation Documentation And Addressing Common Validation Challenges
    • Preparing Confidently For FDA Audits And ….
    • Understanding FDA Oversight And System Development Life Cycle (SDLC)
    • Mastering Computer System Validation And GAMP 5 Software Categorization
    • Achieving 21 CFR Part 11 Electronic Records Compliance
    • Strengthening Security, Access Control, And Managing Audit Trails Effectively
    • Creating Robust Validation Documentation And Addressing Common Validation Challenges
    • Preparing Confidently For FDA Audits And Avoiding Common Pitfalls
    • Learning Industry Best Practices Through Dynamic Interactive Q&A Session

Course Description

As 2024 comes to a close, are you ready to tackle FDA compliance head-on?

If you’re feeling overwhelmed by the intricate regulations of 21 CFR Part 11, this is your chance to start 2025 with confidence and clarity.

Key Pain Points Solved:

    • Worried about meeting stringent FDA audit standards and compliance requirements?
    • Concerned about costly penalties or product recalls from non-compliance?
    • Unclear about which systems are regulated or how to validate them?
    • Struggling to educate your team on the importance of compliance and its consequences?
    • Finding it challenging to navigate technical jargon when collaborating with IT, QA, and compliance teams?

If any of these resonate, this training is tailored for you!

This exclusive end-of-year training simplifies the complexities of 21 CFR Part 11, ensuring you’re ready to meet evolving compliance requirements with confidence in the new year.

Key Takeaways for 2024’s Close:

    • Streamline system compliance: Navigate FDA rules, mitigate risks, and establish secure electronic record-keeping systems.
    • Comprehensive insights: Master the importance of electronic records and electronic signatures (ER/ES) in regulated systems and integrate them into your validation process.
    • Proven strategies: Implement stringent protocols like secure passwords, user IDs, and segregation of duties to meet the toughest standards.
    • Future-proof knowledge: Prepare for regulatory and technological changes that intensify validation challenges.

Why Attend This Year-End Training?

Led by industry expert Carolyn Troiano, this 3-hour webinar offers actionable insights to streamline compliance, reduce risks, and ensure your organization’s success in 2025.

End the year strong and enter 2025 ahead of the compliance curve!

Register now to simplify 21 CFR Part 11 compliance and secure your future success!

As 2024 comes to a close, are you ready to tackle FDA compliance head-on?

If you’re feeling overwhelmed by the intricate regulations of 21 CFR Part 11, this is your chance to start 2025 with confidence and clarity.

Key Pain Points Solved:

    • Worried about meeting stringent FDA audit standards and compliance requirements?
    • Concerned about costly penalties or product recalls from non-compliance?
    • Unclear about which systems are regulated or how to validate them?
    • Struggling to educate your team on the importance of compliance and its consequences?
    • Finding it challenging to navigate technical jargon when collaborating with IT, QA, and compliance teams?

If any of these resonate, this training is tailored for you!

This exclusive end-of-year training simplifies the complexities of 21 CFR Part 11, ensuring you’re ready to meet evolving compliance requirements with confidence in the new year.

Key Takeaways for 2024’s Close:

    • Streamline system compliance: Navigate FDA rules, mitigate risks, and establish secure electronic record-keeping systems.
    • Comprehensive insights: Master the importance of electronic records and electronic signatures (ER/ES) in regulated systems and integrate them into your validation process.
    • Proven strategies: Implement stringent protocols like secure passwords, user IDs, and segregation of duties to meet the toughest standards.
    • Future-proof knowledge: Prepare for regulatory and technological changes that intensify validation challenges.

Why Attend This Year-End Training?

Led by industry expert Carolyn Troiano, this 3-hour webinar offers actionable insights to streamline compliance, reduce risks, and ensure your organization’s success in 2025.

End the year strong and enter 2025 ahead of the compliance curve!

Register now to simplify 21 CFR Part 11 compliance and secure your future success!

Why you should attend

In an era where digitalization reigns supreme, non-compliance with 21 CFR Part 11 can lead to costly corrective actions, hefty penalties, and significant reputational damage that can jeopardize your competitive position.

“Did you know? FDA warning letters citing 21 CFR Part 11 issues have surged by 8% in the last two years. Ignorance is no longer bliss – it’s a ticking time bomb.”

Why This Seminar is Crucial:

    • FDA Mandate: The FDA requires all computer systems handling regulated data to be validated according to their guidance on computerized systems. This guidance, first issued in 1983, remains crucial today, despite evolving technologies.
    • Comprehensive Understanding: This seminar offers an in-depth exploration of the FDA’s 21 CFR Part 11 guidance on electronic records and electronic signatures (ER/ES) for computer systems under FDA regulation.
    • Strategic Validation: Learn how to develop a robust validation strategy that ensures your system meets FDA requirements and maintains a validated state throughout its entire life cycle, from conception to retirement.
    • Tailored Approach: Understand how to apply ER/ES capability based on specific cases and assess the risks of non-compliance, ensuring your approach is both effective and efficient.

Why You Can’t Afford to Miss This:

By attending this seminar, you’ll gain the essential knowledge to identify, address, and avoid potential pitfalls, safeguarding the integrity, reliability, and legal compliance of your digital records.

Enroll Now!

In an era where digitalization reigns supreme, non-compliance with 21 CFR Part 11 can lead to costly corrective actions, hefty penalties, and significant reputational damage that can jeopardize your competitive position.

“Did you know? FDA warning letters citing 21 CFR Part 11 issues have surged by 8% in the last two years. Ignorance is no longer bliss – it’s a ticking time bomb.”

Why This Seminar is Crucial:

    • FDA Mandate: The FDA requires all computer systems handling regulated data to be validated according to their guidance on computerized systems. This guidance, first issued in 1983, remains crucial today, despite evolving technologies.
    • Comprehensive Understanding: This seminar offers an in-depth exploration of the FDA’s 21 CFR Part 11 guidance on electronic records and electronic signatures (ER/ES) for computer systems under FDA regulation.
    • Strategic Validation: Learn how to develop a robust validation strategy that ensures your system meets FDA requirements and maintains a validated state throughout its entire life cycle, from conception to retirement.
    • Tailored Approach: Understand how to apply ER/ES capability based on specific cases and assess the risks of non-compliance, ensuring your approach is both effective and efficient.

Why You Can’t Afford to Miss This:

By attending this seminar, you’ll gain the essential knowledge to identify, address, and avoid potential pitfalls, safeguarding the integrity, reliability, and legal compliance of your digital records.

Enroll Now!

Areas Covered

Session 1 (90 Mins): Navigating FDA Regulatory Oversight, Computer System Validation, and 21 CFR Part 11 Compliance

    • FDA Regulatory Oversight
    • System Development Life Cycle (SDLC) Methodology
    • Computer System Validation (CSV)
    • GAMP 5 Software Categorization
    • System Risk Assessment
    • 21 CFR Part 11 Compliance (Electronic Records/Electronic Signatures)

Session 2 (90 Mins): Ensuring Secure Data Management, Addressing Validation Issues, and Preparing for FDA Audits

    • Security, Access Control, Change Control, and Audit Trail
    • Validation Documentation
    • 7 Most Common Problems with Validation
    • FDA Audit Preparation
    • Industry Best Practices and Common Pitfalls
    • 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

Session 1 (90 Mins): Navigating FDA Regulatory Oversight, Computer System Validation, and 21 CFR Part 11 Compliance

    • FDA Regulatory Oversight
    • System Development Life Cycle (SDLC) Methodology
    • Computer System Validation (CSV)
    • GAMP 5 Software Categorization
    • System Risk Assessment
    • 21 CFR Part 11 Compliance (Electronic Records/Electronic Signatures)

Session 2 (90 Mins): Ensuring Secure Data Management, Addressing Validation Issues, and Preparing for FDA Audits

    • Security, Access Control, Change Control, and Audit Trail
    • Validation Documentation
    • 7 Most Common Problems with Validation
    • FDA Audit Preparation
    • Industry Best Practices and Common Pitfalls
    • 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

Who is this course for

Maximize The Learning Experience in A Group Setting!

    • Leaders Seeking Practical Strategies to Ensure Team Compliance with FDA Standards
    • Department Heads Aiming to Streamline Compliance Processes Across Their Teams
    • Professionals Overwhelmed by Regulatory Jargon Needing Clearer Compliance Guidance
    • Training Heads Designing Learning Paths to Build Team Compliance Expertise
    • HR Professionals Developing Programs to Address Compliance Knowledge Gaps
    • Quality Assurance Experts Focused on Minimizing Risks of Non-Compliance
    • IT Professionals Managing the Validation and Security of Computer Systems
    • Compliance Officers Ensuring Seamless Integration of ER/ES in Operations
    • Auditors and Inspectors Preparing for Flawless FDA Audit Readiness

Maximize The Learning Experience in A Group Setting!

    • Leaders Seeking Practical Strategies to Ensure Team Compliance with FDA Standards
    • Department Heads Aiming to Streamline Compliance Processes Across Their Teams
    • Professionals Overwhelmed by Regulatory Jargon Needing Clearer Compliance Guidance
    • Training Heads Designing Learning Paths to Build Team Compliance Expertise
    • HR Professionals Developing Programs to Address Compliance Knowledge Gaps
    • Quality Assurance Experts Focused on Minimizing Risks of Non-Compliance
    • IT Professionals Managing the Validation and Security of Computer Systems
    • Compliance Officers Ensuring Seamless Integration of ER/ES in Operations
    • Auditors and Inspectors Preparing for Flawless FDA Audit Readiness

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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