How to Stop Spreadsheet Nightmares: Master Risk-Based Validation of Spreadsheet Applications
Elevate Your Expertise: Streamline Validation, Secure Data, and Excel in Compliance!
Instructor :
Carolyn Troiano
Webinar ID:
10295
Date: DEC 03, 2024 (TUE)
Start Time: 9 AM PT - 12 PM PT
Duration: 3 Hrs.
What you will learn
- Session overview highlights spreadsheet validation importance.
- Identifying GxP spreadsheets and their compliance needs.
- Introducing CSV and CSA for FDA validation efficiency.
- SDLC methodologies applied to Excel spreadsheet validation.
- Maintaining validation and data integrity in …
- Session overview highlights spreadsheet validation importance.
- Identifying GxP spreadsheets and their compliance needs.
- Introducing CSV and CSA for FDA validation efficiency.
- SDLC methodologies applied to Excel spreadsheet validation.
- Maintaining validation and data integrity in spreadsheets.
- Understanding 21 CFR Part 11 compliance for spreadsheets.
- Risk assessments guide validation rationale development.
- FDA inspection preparation for GxP spreadsheets discussed.
- Industry best practices shared, with interactive Q&A session
Course Description
Discover how to transform your spreadsheet management from a compliance nightmare into a streamlined, FDA-compliant process.
This 3-hour webinar, led by industry expert Carolyn Troiano, delves into the critical aspects of risk-based validation of spreadsheet applications, focusing on ensuring data integrity and regulatory compliance.
Whether you’re dealing with Microsoft Excel, Google Sheets, or any other spreadsheet software, the principles of Good Practice (GxP) and FDA’s 21 CFR Part 11 can no longer be an oversight.
From validation planning and testing to maintenance and audit preparation, this course offers a comprehensive guide to mastering spreadsheet validation.
Equip yourself with the tools and knowledge to ensure your spreadsheet applications support, rather than hinder, your compliance efforts.
- Understand the criticality of identifying GxP systems and applying appropriate validation strategies to spreadsheet applications.
- Dive deep into the principles of Computer System Validation (CSV) and Computer Software Assurance (CSA), and learn how to leverage these frameworks to optimize your validation efforts.
- Gain insights into the System Development Life Cycle (SDLC) approach tailored for Excel spreadsheet applications, highlighting best practices for documentation, development, testing, and maintenance.
- Explore the essentials of maintaining validated states and ensuring data integrity, alongside compliance with 21 CFR Part 11 for electronic records and signatures.
This training is crafted to enhance your proficiency in navigating the complexities of spreadsheet validation, focusing on risk-based approaches that align with the latest industry standards and FDA guidance.
Equip yourself with the expertise to conduct thorough risk assessments, develop robust validation rationales, and prepare confidently for FDA inspections.
Join Now!
Discover how to transform your spreadsheet management from a compliance nightmare into a streamlined, FDA-compliant process.
This 3-hour webinar, led by industry expert Carolyn Troiano, delves into the critical aspects of risk-based validation of spreadsheet applications, focusing on ensuring data integrity and regulatory compliance.
Whether you’re dealing with Microsoft Excel, Google Sheets, or any other spreadsheet software, the principles of Good Practice (GxP) and FDA’s 21 CFR Part 11 can no longer be an oversight.
From validation planning and testing to maintenance and audit preparation, this course offers a comprehensive guide to mastering spreadsheet validation.
Equip yourself with the tools and knowledge to ensure your spreadsheet applications support, rather than hinder, your compliance efforts.
- Understand the criticality of identifying GxP systems and applying appropriate validation strategies to spreadsheet applications.
- Dive deep into the principles of Computer System Validation (CSV) and Computer Software Assurance (CSA), and learn how to leverage these frameworks to optimize your validation efforts.
- Gain insights into the System Development Life Cycle (SDLC) approach tailored for Excel spreadsheet applications, highlighting best practices for documentation, development, testing, and maintenance.
- Explore the essentials of maintaining validated states and ensuring data integrity, alongside compliance with 21 CFR Part 11 for electronic records and signatures.
This training is crafted to enhance your proficiency in navigating the complexities of spreadsheet validation, focusing on risk-based approaches that align with the latest industry standards and FDA guidance.
Equip yourself with the expertise to conduct thorough risk assessments, develop robust validation rationales, and prepare confidently for FDA inspections.
Join Now!
Why you should attend
In an era where data integrity and compliance can make or break your operations, understanding how to validate spreadsheet applications is no longer optional. This webinar offers:
- Insight into the FDA’s regulatory focus on spreadsheet validation, highlighting why it’s critical for your business.
- Practical steps for risk-based validation, ensuring your spreadsheets are compliant with 21 CFR Part 11 and other relevant standards.
- Learn from industry experts about integrating Computer Software Assurance (CSA) into your validation processes, potentially reducing workload and streamlining validation efforts.
- Real-world examples and case studies demonstrating common pitfalls and best practices in spreadsheet validation.
- Guidance on developing robust audit trails, security measures, and data integrity controls for your spreadsheet applications.
- Expert advice on maintaining validated states through change control and documentation.
- An opportunity to ask questions and gain insights from a leading validation expert, Carolyn Troiano.
Attending this session is pivotal for professionals seeking to fortify their knowledge and skills in validating spreadsheet applications used in regulated environments. With an emphasis on practical application and compliance, this training offers invaluable benefits.
Whether you’re responsible for developing, validating, or maintaining spreadsheet applications in a GxP-regulated environment, this training is designed to elevate your capabilities, ensuring you’re well-prepared to meet the challenges of today’s dynamic regulatory landscape and safeguard your organization’s data integrity.
Enroll Now!
In an era where data integrity and compliance can make or break your operations, understanding how to validate spreadsheet applications is no longer optional. This webinar offers:
- Insight into the FDA’s regulatory focus on spreadsheet validation, highlighting why it’s critical for your business.
- Practical steps for risk-based validation, ensuring your spreadsheets are compliant with 21 CFR Part 11 and other relevant standards.
- Learn from industry experts about integrating Computer Software Assurance (CSA) into your validation processes, potentially reducing workload and streamlining validation efforts.
- Real-world examples and case studies demonstrating common pitfalls and best practices in spreadsheet validation.
- Guidance on developing robust audit trails, security measures, and data integrity controls for your spreadsheet applications.
- Expert advice on maintaining validated states through change control and documentation.
- An opportunity to ask questions and gain insights from a leading validation expert, Carolyn Troiano.
Attending this session is pivotal for professionals seeking to fortify their knowledge and skills in validating spreadsheet applications used in regulated environments. With an emphasis on practical application and compliance, this training offers invaluable benefits.
Whether you’re responsible for developing, validating, or maintaining spreadsheet applications in a GxP-regulated environment, this training is designed to elevate your capabilities, ensuring you’re well-prepared to meet the challenges of today’s dynamic regulatory landscape and safeguard your organization’s data integrity.
Enroll Now!
Course Agenda
- Understanding GxP Systems and compliance requirements.
- Overview of Computer System Validation (CSV).
- The essentials of validation planning.
- Introducing CSV and CSA for FDA validation efficiency.
- Crafting precise requirements for validation.
- SDLC methodologies applied to Excel spreadsheet validation.
- Validation testing strategies and best practices.
- Maintaining validation through effective maintenance.
- Steps for Excel Spreadsheet Validation.
- Real-world spreadsheet validation examples.
- Adopting a pragmatic approach to spreadsheet validation.
- Risk Assessment techniques for spreadsheet applications.
- Documentation essentials for compliance and validation.
- Change Control management for validated spreadsheets.
- Ensuring data integrity in your spreadsheet applications.
- Addressing FDA regulatory oversight and compliance.
- Dispelling myths about spreadsheet validation and FDA expectations
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
- Understanding GxP Systems and compliance requirements.
- Overview of Computer System Validation (CSV).
- The essentials of validation planning.
- Introducing CSV and CSA for FDA validation efficiency.
- Crafting precise requirements for validation.
- SDLC methodologies applied to Excel spreadsheet validation.
- Validation testing strategies and best practices.
- Maintaining validation through effective maintenance.
- Steps for Excel Spreadsheet Validation.
- Real-world spreadsheet validation examples.
- Adopting a pragmatic approach to spreadsheet validation.
- Risk Assessment techniques for spreadsheet applications.
- Documentation essentials for compliance and validation.
- Change Control management for validated spreadsheets.
- Ensuring data integrity in your spreadsheet applications.
- Addressing FDA regulatory oversight and compliance.
- Dispelling myths about spreadsheet validation and FDA expectations
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
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 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.
