Excel in FDA Compliance: Effortless Spreadsheet Validation to Eliminate 483 Citations
Be Proactive, Not Reactive: Master Spreadsheet Validation Before FDA Auditors Do!
Instructor :
David Nettelton
Webinar ID:
4193
Date: NOV 26, 2024 (TUE)
Start Time: 10 AM PT - 11:15 AM PT
Duration: 75 Mins
Buy This Course in a Pack of 2 courses at 25% Discount HERE:
📊 The Compliance & Documentation Essentials Pack (Pack of 2)
“Stay Ahead in Regulatory Compliance and Document Control!”
2 Courses Included:
Why This Pack?
Equip yourself with critical knowledge in two rapidly evolving areas: social media regulation and data integrity for spreadsheet use in FDA-regulated environments. With an increasing emphasis on digital and social media data in regulatory compliance, these courses are designed to help compliance officers and documentation managers adapt to new requirements efficiently.
Target Audience: Compliance Managers, Quality Assurance Specialists, Documentation Managers
Why Buy the Pack?
-
- Cross-Cutting Compliance Insight: Address two crucial, high-impact areas of compliance in one purchase.
Buy This Course in a Pack of 2 courses at 25% Discount HERE:
📊 The Compliance & Documentation Essentials Pack (Pack of 2)
“Stay Ahead in Regulatory Compliance and Document Control!”
2 Courses Included:
Why This Pack?
Equip yourself with critical knowledge in two rapidly evolving areas: social media regulation and data integrity for spreadsheet use in FDA-regulated environments. With an increasing emphasis on digital and social media data in regulatory compliance, these courses are designed to help compliance officers and documentation managers adapt to new requirements efficiently.
Target Audience: Compliance Managers, Quality Assurance Specialists, Documentation Managers
Why Buy the Pack?
-
- Cross-Cutting Compliance Insight: Address two crucial, high-impact areas of compliance in one purchase.
- Save & Stay Compliant: Gain significant savings while ensuring that all aspects of digital and documentation regulations are met.
- Actionable Knowledge: Gain immediately applicable strategies to avoid non-compliance in social media and data documentation.
Note: Do you want to custom design your pack and choose courses of your choice? Just drop us an email at support@compliancemeet.com or call at Toll Free: +1 (888) 959-4972. We’ll be happy to help you!
Buy Both Courses at a 25% discount HERE
What you will learn
-
- Develop GxP-Compliant Excel Applications Aligned With Regulatory Standards.
- Utilize Excel’s Built-In 21 CFR Part 11 Compliance Features.
- Implement Audit Trails And Data Security Without Complex Programming.
- Configure Multi-User Access For Collaborative, Regulated Environments.
- Reduce Validation Time And Documentation With Streamlined Methods.
- Avoid FDA 483 Citations By ….
-
- Develop GxP-Compliant Excel Applications Aligned With Regulatory Standards.
- Utilize Excel’s Built-In 21 CFR Part 11 Compliance Features.
- Implement Audit Trails And Data Security Without Complex Programming.
- Configure Multi-User Access For Collaborative, Regulated Environments.
- Reduce Validation Time And Documentation With Streamlined Methods.
- Avoid FDA 483 Citations By Mastering Compliance Best Practices.
- Specify And Test Applications To Meet Industry Compliance Standards.
Course Description
“Did you know that half of all FDA citations (483s) stem from data integrity issues, often rooted in Excel spreadsheet errors?”
The true cost of these citations extends beyond financial losses to include erosion of trust, reputation damage, and significant operational disruptions.
Ready to master the art of configuring and validating GxP-compliant Excel spreadsheets to avoid FDA 483s?
Join us for a comprehensive 75-minute session where you’ll embark on a journey through Excel, designed specifically for FDA-regulated industries. Our expert, David Nettleton, will guide you through:
-
- Creating foolproof Audit Trails: Ensure every change is tracked and traceable.
- Implementing robust Security Features: Protect your data from unauthorized access and ensure compliance with 21 CFR Part 11.
- Assuring flawless Data Entry Verification: Validate your data input processes to maintain integrity and accuracy.
Curious about validating applications with minimal paperwork?
-
- Learn how to create an Excel spreadsheet application that is GxP compliant.
- Understand how to validate your application with minimal documentation.
- Follow the step-by-step instructions as we configure Excel for audit trails, security features, and data entry verification.
This session is more than a learning experience—it’s a transformative event designed to make you an Excel maestro, significantly reducing time and costs!
This session includes an interactive workshop so you can learn techniques that are important to you. Bring your laptop and use Excel for your own needs.
Key Takeaways:
-
- Develop GxP-compliant spreadsheet applications without extensive programming.
- Utilize Excel’s built-in 21 CFR Part 11 features to streamline compliance.
- Configure Excel for audit trails, security features, and multiple user access.
- Reduce validation time and costs while enhancing compliance.
- Avoid FDA 483s and Warning Letters by adhering to industry best practices.
Intrigued?
Take the plunge and transform your approach. Secure Your Spot Now!
Join Now!
“Did you know that half of all FDA citations (483s) stem from data integrity issues, often rooted in Excel spreadsheet errors?”
The true cost of these citations extends beyond financial losses to include erosion of trust, reputation damage, and significant operational disruptions.
Ready to master the art of configuring and validating GxP-compliant Excel spreadsheets to avoid FDA 483s?
Join us for a comprehensive 75-minute session where you’ll embark on a journey through Excel, designed specifically for FDA-regulated industries. Our expert, David Nettleton, will guide you through:
-
- Creating foolproof Audit Trails: Ensure every change is tracked and traceable.
- Implementing robust Security Features: Protect your data from unauthorized access and ensure compliance with 21 CFR Part 11.
- Assuring flawless Data Entry Verification: Validate your data input processes to maintain integrity and accuracy.
Curious about validating applications with minimal paperwork?
-
- Learn how to create an Excel spreadsheet application that is GxP compliant.
- Understand how to validate your application with minimal documentation.
- Follow the step-by-step instructions as we configure Excel for audit trails, security features, and data entry verification.
This session is more than a learning experience—it’s a transformative event designed to make you an Excel maestro, significantly reducing time and costs!
This session includes an interactive workshop so you can learn techniques that are important to you. Bring your laptop and use Excel for your own needs.
Key Takeaways:
-
- Develop GxP-compliant spreadsheet applications without extensive programming.
- Utilize Excel’s built-in 21 CFR Part 11 features to streamline compliance.
- Configure Excel for audit trails, security features, and multiple user access.
- Reduce validation time and costs while enhancing compliance.
- Avoid FDA 483s and Warning Letters by adhering to industry best practices.
Intrigued?
Take the plunge and transform your approach. Secure Your Spot Now!
Join Now!
Why you should attend
In the FDA-regulated life sciences industry, maintaining compliance with Title 21 CFR Part 11 is more than just a regulatory checkbox—it’s essential for operational success and protecting your organization’s reputation.
Non-compliance can lead to FDA 483 citations, warning letters, and severe setbacks that impact both time and resources.
This training empowers you with the skills to transform MS Excel—a commonly used tool—into a fully GxP-compliant application that meets rigorous compliance standards.
Why This Course is Essential:
-
- Prevent Costly Citations: Learn to configure Excel for audit-ready compliance, reducing the risk of FDA 483s.
- Ensure Data Integrity: Understand how to set up secure data entry and audit trails that support accurate and reliable data.
- Streamline Compliance Efforts: Discover Excel’s built-in 21 CFR Part 11 features to simplify compliance without complex programming.
- Minimize Documentation Burden: Implement validation techniques that require minimal paperwork—saving both time and resources.
- Protect Operational Continuity: Gain the skills to prevent compliance issues before they disrupt your workflow and productivity.
By attending, you will:
-
- Gain Essential Compliance Knowledge: Develop GxP-compliant Excel spreadsheet applications that enhance both efficiency and compliance.
- Reduce Validation Costs: Implement strategies that help reduce both time and costs associated with validation.
- Stay Ahead of FDA Requirements: Learn best practices to avoid warning letters and stay audit-ready at all times.
Turn compliance from a challenge into a competitive advantage. Join us to safeguard your operations and advance your career!
Enroll Today to Secure Your Spot!
In the FDA-regulated life sciences industry, maintaining compliance with Title 21 CFR Part 11 is more than just a regulatory checkbox—it’s essential for operational success and protecting your organization’s reputation.
Non-compliance can lead to FDA 483 citations, warning letters, and severe setbacks that impact both time and resources.
This training empowers you with the skills to transform MS Excel—a commonly used tool—into a fully GxP-compliant application that meets rigorous compliance standards.
Why This Course is Essential:
-
- Prevent Costly Citations: Learn to configure Excel for audit-ready compliance, reducing the risk of FDA 483s.
- Ensure Data Integrity: Understand how to set up secure data entry and audit trails that support accurate and reliable data.
- Streamline Compliance Efforts: Discover Excel’s built-in 21 CFR Part 11 features to simplify compliance without complex programming.
- Minimize Documentation Burden: Implement validation techniques that require minimal paperwork—saving both time and resources.
- Protect Operational Continuity: Gain the skills to prevent compliance issues before they disrupt your workflow and productivity.
By attending, you will:
-
- Gain Essential Compliance Knowledge: Develop GxP-compliant Excel spreadsheet applications that enhance both efficiency and compliance.
- Reduce Validation Costs: Implement strategies that help reduce both time and costs associated with validation.
- Stay Ahead of FDA Requirements: Learn best practices to avoid warning letters and stay audit-ready at all times.
Turn compliance from a challenge into a competitive advantage. Join us to safeguard your operations and advance your career!
Enroll Today to Secure Your Spot!
Course Agenda
-
- Develop GxP-Compliant Spreadsheet Applications: Learn to create Excel applications that align seamlessly with GxP standards to ensure regulatory compliance.
- Explore Excel’s 21 CFR Part 11 Capabilities: Uncover Excel’s built-in features that support 21 CFR Part 11 compliance, making validation straightforward and achievable.
- Implement Essential GxP Features Without Coding: Configure critical compliance features in Excel, including audit trails and data security, without needing complex macros or programming.
- Set Up Impeccable Audit Trails: Ensure every data change is tracked and traceable, supporting robust data integrity.
- Fortify Security Features: Protect data from unauthorized access by configuring file and cell protections to meet compliance requirements.
- Enhance Data Verification Accuracy: Establish reliable data entry verification processes to maintain accuracy and integrity across your applications.
- Facilitate Multi-User Operations: Configure Excel for multiple users, enabling smooth operations in collaborative and regulated environments.
- Minimize Validation Time and Documentation: Learn streamlined validation methods to reduce time and costs while requiring minimal paperwork—helping you focus on efficient compliance.
- Avoid FDA 483 Citations and Warning Letters: Discover strategies to sidestep common compliance pitfalls, safeguarding your operations from costly citations.
- Identify Validation Essentials: Gain clarity on what aspects of Excel applications require validation and which do not, ensuring a focused approach to compliance.
- Master Application Specification and Testing: Follow step-by-step instructions on specifying and testing your application for compliance, ensuring it meets industry standards.
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.
-
- Develop GxP-Compliant Spreadsheet Applications: Learn to create Excel applications that align seamlessly with GxP standards to ensure regulatory compliance.
- Explore Excel’s 21 CFR Part 11 Capabilities: Uncover Excel’s built-in features that support 21 CFR Part 11 compliance, making validation straightforward and achievable.
- Implement Essential GxP Features Without Coding: Configure critical compliance features in Excel, including audit trails and data security, without needing complex macros or programming.
- Set Up Impeccable Audit Trails: Ensure every data change is tracked and traceable, supporting robust data integrity.
- Fortify Security Features: Protect data from unauthorized access by configuring file and cell protections to meet compliance requirements.
- Enhance Data Verification Accuracy: Establish reliable data entry verification processes to maintain accuracy and integrity across your applications.
- Facilitate Multi-User Operations: Configure Excel for multiple users, enabling smooth operations in collaborative and regulated environments.
- Minimize Validation Time and Documentation: Learn streamlined validation methods to reduce time and costs while requiring minimal paperwork—helping you focus on efficient compliance.
- Avoid FDA 483 Citations and Warning Letters: Discover strategies to sidestep common compliance pitfalls, safeguarding your operations from costly citations.
- Identify Validation Essentials: Gain clarity on what aspects of Excel applications require validation and which do not, ensuring a focused approach to compliance.
- Master Application Specification and Testing: Follow step-by-step instructions on specifying and testing your application for compliance, ensuring it meets industry standards.
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
Everybody benefits from watching this. Even better when done as a group!
-
- Compliance Leaders Striving to Avoid Costly FDA 483 Citations
- Quality Assurance Professionals Focused on Data Integrity
- Regulatory Affairs Specialists Aiming to Streamline Compliance Processes
- Training Managers Developing Compliance-Centric Learning Paths
- Operational Managers Seeking to Enhance Team Compliance Skills
- Human Resources Professionals Supporting Compliance Training Initiatives
- IT and Systems Administrators Ensuring Secure Data Configurations
- Document Control Specialists Managing GxP Documentation Requirements
- Financial Officers Reducing Compliance-Related Costs and Risks
Everybody benefits from watching this. Even better when done as a group!
-
- Compliance Leaders Striving to Avoid Costly FDA 483 Citations
- Quality Assurance Professionals Focused on Data Integrity
- Regulatory Affairs Specialists Aiming to Streamline Compliance Processes
- Training Managers Developing Compliance-Centric Learning Paths
- Operational Managers Seeking to Enhance Team Compliance Skills
- Human Resources Professionals Supporting Compliance Training Initiatives
- IT and Systems Administrators Ensuring Secure Data Configurations
- Document Control Specialists Managing GxP Documentation Requirements
- Financial Officers Reducing Compliance-Related Costs and Risks
Instructor Profile
David Nettleton, Computer System Validation’s principal, is an industry leader, author, and teacher for 21 CFR Part 11, Annex 11, HIPAA, EU GDPR software validation, and computer system validation.
He is involved with the development, purchase, installation, operation and maintenance of computerized systems used in FDA compliant applications.
He has completed more than 300 mission critical laboratory, clinical, and manufacturing software implementation projects. His most recent book is Software as a Service (SaaS) Risk-Based Validation With Time-Saving Templates, which provides fill-in-the-blank templates for completing a COTS software validation project.
