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: DEC 02, 2024 (MON)
Start Time: 9 AM PT - 12 PM PT
Duration: 3 Hrs.
What will you learn
-
- Understand FDA Regulatory Oversight And Its Impact On Compliance
- Learn System Development Life Cycle (SDLC) Methodology For Validation
- Explore Computer System Validation (CSV) Essentials And Best Practices
- Understand GAMP 5 Software Categorization For Effective Validation
- Conduct System Risk Assessment To Identify Potential Compliance Issues
- Achieve 21 CFR Part 11 Compliance For Electronic Records/Signatures
- Implement Security, Access Control, And ….
-
- Understand FDA Regulatory Oversight And Its Impact On Compliance
- Learn System Development Life Cycle (SDLC) Methodology For Validation
- Explore Computer System Validation (CSV) Essentials And Best Practices
- Understand GAMP 5 Software Categorization For Effective Validation
- Conduct System Risk Assessment To Identify Potential Compliance Issues
- Achieve 21 CFR Part 11 Compliance For Electronic Records/Signatures
- Implement Security, Access Control, And Audit Trail Management
- Prepare For FDA Audits And Address Common Validation Problems
- Apply Industry Best Practices And Avoid Common Compliance Pitfalls
Course Description
Are you struggling to keep up with the ever-evolving FDA regulations, especially the intricate 21 CFR Part 11?
-
- Worried about meeting all requirements and passing increasingly stringent FDA audits?
- Concerned about the risk of hefty penalties or product recalls due to non-compliance?
- Unsure about which systems are regulated and how to validate them?
- Facing challenges in educating your team on the importance of compliance and the penalties for non-compliance?
- Overwhelmed by technical jargon when communicating with Quality Assurance, IT, and compliance teams as a non-technical person?
If you answered ‘yes’ to any of these questions, this training is precisely what you need! Don’t miss this opportunity to alleviate your concerns and enhance your understanding of FDA regulations, specifically 21 CFR Part 11.
This training is meticulously designed to demystify the complex guidelines under 21 CFR Part 11, the federal regulation governing electronic records and electronic signatures in the United States.
Key Takeaways:
-
- Focus on computer systems: Ensure your organization effectively navigates the FDA’s rules, mitigating the risks of non-compliance, and confidently establishing robust electronic record-keeping systems.
- Comprehensive coverage: Understand the importance of electronic record/electronic signature (ER/ES) capability in FDA-regulated computer systems and how to incorporate compliance into your overall validation program.
- Stay ahead of the curve: Learn how to implement strict security protocols, including secure passwords and user identification, and maintain segregation of duties to comply with the rule’s stringent requirements.
As the regulatory landscape evolves and new technologies emerge, these can introduce complex oversight layers, intensifying system validation and challenging the cost-benefit balance. A nuanced understanding of 21 CFR Part 11 is crucial for successful adaptation.
This comprehensive training, led by industry expert Carolyn Troiano, will equip you with essential knowledge and practical strategies to ensure seamless compliance with the stringent FDA regulations.
Join Now!
Are you struggling to keep up with the ever-evolving FDA regulations, especially the intricate 21 CFR Part 11?
-
- Worried about meeting all requirements and passing increasingly stringent FDA audits?
- Concerned about the risk of hefty penalties or product recalls due to non-compliance?
- Unsure about which systems are regulated and how to validate them?
- Facing challenges in educating your team on the importance of compliance and the penalties for non-compliance?
- Overwhelmed by technical jargon when communicating with Quality Assurance, IT, and compliance teams as a non-technical person?
If you answered ‘yes’ to any of these questions, this training is precisely what you need! Don’t miss this opportunity to alleviate your concerns and enhance your understanding of FDA regulations, specifically 21 CFR Part 11.
This training is meticulously designed to demystify the complex guidelines under 21 CFR Part 11, the federal regulation governing electronic records and electronic signatures in the United States.
Key Takeaways:
-
- Focus on computer systems: Ensure your organization effectively navigates the FDA’s rules, mitigating the risks of non-compliance, and confidently establishing robust electronic record-keeping systems.
- Comprehensive coverage: Understand the importance of electronic record/electronic signature (ER/ES) capability in FDA-regulated computer systems and how to incorporate compliance into your overall validation program.
- Stay ahead of the curve: Learn how to implement strict security protocols, including secure passwords and user identification, and maintain segregation of duties to comply with the rule’s stringent requirements.
As the regulatory landscape evolves and new technologies emerge, these can introduce complex oversight layers, intensifying system validation and challenging the cost-benefit balance. A nuanced understanding of 21 CFR Part 11 is crucial for successful adaptation.
This comprehensive training, led by industry expert Carolyn Troiano, will equip you with essential knowledge and practical strategies to ensure seamless compliance with the stringent FDA regulations.
Join Now!
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:
-
- 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
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:
-
- 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!
-
- Quality Assurance Managers
- IT Managers
- Regulatory Affairs Specialists
- Compliance Managers
- Validation Specialists/Managers
- Clinical Operations Managers
- Data Managers in Clinical Trials
- Computer System Validation Specialists
- Quality Control Managers
- Business Analysts in FDA-Regulated Industries
- Clinical Research Coordinators
- Regulatory Compliance Officers
- Process Validation Managers
- Validation Engineers
- Technology Transfer Specialists in Life Sciences
- Document Control Managers
- Clinical Trial Associates
- Clinical Site Managers/Investigators
- Laboratory Managers in FDA-Regulated Labs
- GMP Compliance Managers
Maximize The Learning Experience in A Group Setting!
-
- Quality Assurance Managers
- IT Managers
- Regulatory Affairs Specialists
- Compliance Managers
- Validation Specialists/Managers
- Clinical Operations Managers
- Data Managers in Clinical Trials
- Computer System Validation Specialists
- Quality Control Managers
- Business Analysts in FDA-Regulated Industries
- Clinical Research Coordinators
- Regulatory Compliance Officers
- Process Validation Managers
- Validation Engineers
- Technology Transfer Specialists in Life Sciences
- Document Control Managers
- Clinical Trial Associates
- Clinical Site Managers/Investigators
- Laboratory Managers in FDA-Regulated Labs
- GMP Compliance Managers
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 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.
