Simplify Your Data: Excel Spreadsheet Validation Made Easy for FDA Compliance
Transform Your Data Handling – Validate with Confidence and Precision!
Instructor :
David Nettelton
Webinar ID:
4193
Date: JUL 15, 2024 (MON)
Start Time: 10 am PT
Duration: 75 Mins
What you will learn
- Align Spreadsheets with GxP Standards Effortlessly.
- Explore Excel’s 21 CFR Part 11 Compliance Capabilities.
- Integrate GxP Features in Excel Without Complex Programming.
- Reliable Audit Trails, Enhanced Security, Verification …
- Align Spreadsheets with GxP Standards Effortlessly.
- Explore Excel’s 21 CFR Part 11 Compliance Capabilities.
- Integrate GxP Features in Excel Without Complex Programming.
- Reliable Audit Trails, Enhanced Security, Verification, Multi-User Functionality.
- Avoid 483s and Warning Letters Through Expert Techniques.
- Utilize Cell and File Protections to Reduce Validation Time and Cost.
- Achieve Higher Compliance with Minimal Resource Use and Paperwork
Course Description
Did you know that half of all FDA citations (483s) arise from data integrity issues, often rooted in Excel spreadsheet errors?
Consider the true cost of these citations: it’s not just about financial losses, but also the erosion of trust, reputation damage, and operational disruptions in your organization.
Ready to master the art of configuring and validating GxP-compliant Excel spreadsheets to avoid FDA 483s? 🎯
Join us in a comprehensive journey through Excel, where you’ll learn:
- How to create foolproof Audit Trails.
- Implementing robust Security Features.
- Assuring flawless Data Entry Verification.
Curious about validating applications with minimal paperwork? 📄
Bring your laptop and customize Excel to meet your unique needs. 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! ⏳💰
Intrigued? Take the plunge and transform your approach.
Secure Your Spot Now! 🌟
Did you know that half of all FDA citations (483s) arise from data integrity issues, often rooted in Excel spreadsheet errors?
Consider the true cost of these citations: it’s not just about financial losses, but also the erosion of trust, reputation damage, and operational disruptions in your organization.
Ready to master the art of configuring and validating GxP-compliant Excel spreadsheets to avoid FDA 483s? 🎯
Join us in a comprehensive journey through Excel, where you’ll learn:
- How to create foolproof Audit Trails.
- Implementing robust Security Features.
- Assuring flawless Data Entry Verification.
Curious about validating applications with minimal paperwork? 📄
Bring your laptop and customize Excel to meet your unique needs. 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! ⏳💰
Intrigued? Take the plunge and transform your approach.
Secure Your Spot Now! 🌟
Why you should attend
Elevate Your Compliance in the Life Sciences Arena: Master Title 21 CFR Part 11 with Ease! 🌟
Title 21 CFR Part 11 sets the standard for system security in life sciences.
Compliance is not just a regulatory requirement; it’s essential for smooth, uninterrupted operations. Remember, non-compliance can lead to warning letters and significant setbacks! 🚫
Consider your everyday tools, like MS Excel. They are crucial in 21 CFR Part 11 compliant environments, but transforming them into compliant tools requires skill and knowledge.
- Seeking the blueprint for compliant Excel spreadsheet validation?
- Want to protect your operations from 483s and maintain perfect data integrity?
Our training offers:
- Essential insights and practical skills for effective spreadsheet validation.
- Strategies to enhance compliance while reducing resource strain.
- Techniques for validating applications with minimal documentation.
Join us and transform compliance from a challenge into an advantage!
Enroll Today! 📌
Elevate Your Compliance in the Life Sciences Arena: Master Title 21 CFR Part 11 with Ease! 🌟
Title 21 CFR Part 11 sets the standard for system security in life sciences.
Compliance is not just a regulatory requirement; it’s essential for smooth, uninterrupted operations. Remember, non-compliance can lead to warning letters and significant setbacks! 🚫
Consider your everyday tools, like MS Excel. They are crucial in 21 CFR Part 11 compliant environments, but transforming them into compliant tools requires skill and knowledge.
- Seeking the blueprint for compliant Excel spreadsheet validation?
- Want to protect your operations from 483s and maintain perfect data integrity?
Our training offers:
- Essential insights and practical skills for effective spreadsheet validation.
- Strategies to enhance compliance while reducing resource strain.
- Techniques for validating applications with minimal documentation.
Join us and transform compliance from a challenge into an advantage!
Enroll Today! 📌
Course Agenda
Master the Art of GxP-Compliant Spreadsheet Applications! 🚀
- Craft spreadsheet apps that seamlessly align with GxP standards
- Unravel the magic of Excel’s 21 CFR Part 11 features
- Implement essential GxP features without diving into the maze of programming macros
- Join us as we mold Excel for:
- Impeccable audit trails
- Fortified security features
- Accurate data verification
- Smooth operations for multiple users simultaneously
- Sidestep the pitfalls of 483s and Warning Letters
- Harness the power of cell and file protections
- Slash your validation time and costs dramatically
- Skyrocket compliance while judiciously using fewer resources
- Perfectly validate your application with barely any paperwork
- Discover the nuances: what requires validation and what doesn’t
- Master the steps to specify and test your application
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.
Elevate your spreadsheet skills and compliance knowledge with this transformative guide! 🌟
Master the Art of GxP-Compliant Spreadsheet Applications! 🚀
- Craft spreadsheet apps that seamlessly align with GxP standards
- Unravel the magic of Excel’s 21 CFR Part 11 features
- Implement essential GxP features without diving into the maze of programming macros
- Join us as we mold Excel for:
- Impeccable audit trails
- Fortified security features
- Accurate data verification
- Smooth operations for multiple users simultaneously
- Sidestep the pitfalls of 483s and Warning Letters
- Harness the power of cell and file protections
- Slash your validation time and costs dramatically
- Skyrocket compliance while judiciously using fewer resources
- Perfectly validate your application with barely any paperwork
- Discover the nuances: what requires validation and what doesn’t
- Master the steps to specify and test your application
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.
Elevate your spreadsheet skills and compliance knowledge with this transformative guide! 🌟
Who is this course for
Everybody benefits from watching this. Even better when done as a group!
- Quality Assurance Managers
- Compliance Officers
- Regulatory Affairs Specialists
- Validation Engineers
- Data Integrity Managers
- IT Managers
- Process Engineers
- Documentation Specialists
- Validation Specialists
- Quality Control Managers
- All Excel users
Everybody benefits from watching this. Even better when done as a group!
- Quality Assurance Managers
- Compliance Officers
- Regulatory Affairs Specialists
- Validation Engineers
- Data Integrity Managers
- IT Managers
- Process Engineers
- Documentation Specialists
- Validation Specialists
- Quality Control Managers
- All Excel users
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.
