use of Excel in FDA-regulated environments extends beyond basic data
organization and analysis, requiring meticulous attention to GxP compliance and
avoiding severe compliance issues. In light of recent 2023 incidents involving
pharmaceutical and medical device companies, highlighted by FDA's new
guidelines, the criticality of ensuring 21 CFR Part 11 compliance has never
been more evident. From real-world cases of formula errors leading to
inaccurate drug dosage calculations to instances of unsecured and improperly
maintained spreadsheets risking product compliance records, the consequences of
non-compliant Excel usage are substantial. These lapses not only impact product
quality but also endanger patient safety, as seen in unreliable data collection
in clinical trials due to non-compliant spreadsheets.
us for an enlightening webinar that decodes the process of creating and
validating GxP-compliant spreadsheet applications. We aim to enhance your Excel
proficiency and safeguard against FDA scrutiny, drawing lessons from recent FDA
observations such as data manipulation, incomplete record-keeping, and improper
this practical, hands-on session, we will guide you through configuring Excel
for audit trails, applying security features, and verifying data entry, among
other critical steps. Our goal is to empower you with the knowledge and skills
to validate your application effectively and utilize Excel as a versatile tool
in an FDA-regulated environment.
comprehensive webinar is designed to help you construct GxP-compliant
spreadsheet applications using Excel's built-in 21 CFR Part 11 features,
without programming macros. Along the way, you'll learn techniques to avoid
483s and Warning Letters, reduce validation time and costs, and enhance
compliance with minimal resource use.
Areas covered during the session include:
GxP compliant spreadsheet applications
Excel's built-in 21 CFR Part 11 features
features required for GxP environments without programming macros.
Excel for audit trails, security features, data verification, and multiple
483s and Warning Letters
cell and file protections
the validation scope and minimizing documentation
what does and does not need to be validated.
and testing your application
are spreadsheets so popular?
are they used for?
Why is compliance a problem?
- How is it different from a calculator?
Part 11 applications
- Fill-in-the-blank validation templates
the validated application
- Maintaining, upgrading, re-validation
to turn on the audit trail
- How to view the audit trail
Should You Attend:
light of the FDA's updated guidelines, it's crucial for companies to rigorously
comply with regulations related to the use of Excel spreadsheets in a GxP
regulated environment. Recent case studies reveal significant missteps, such as
formula errors, inadequate audit trails, and flawed data integrity, leading to
severe consequences like FDA warning letters, rejection of drug applications,
and compromised product compliance records.
webinar equips you with essential knowledge and practical skills to adeptly
navigate Excel in an FDA-regulated environment, focusing on creating GxP
compliant spreadsheet applications. You'll learn to effectively employ Excel's
built-in 21 CFR Part 11 features, circumvent compliance pitfalls, and
streamline the validation process. By attending, you will gain the ability to
help your organization avert costly errors, ensuring adherence to the FDA's
stringent regulations and safeguarding data integrity in clinical trials and
miss our engaging Q&A segment where your queries take center stage. Our
speaker dedicates ample time to clarify doubts, ensuring you leave with a
comprehensive understanding of Excel's role in FDA compliance. It's your
opportunity to delve deeper into complex topics and receive personalized
guidance. Join us for a session as informative as it is interactive.
webinar is designed for professionals who regularly use Excel in GxP regulated
environments, such as:
Assurance and Quality Control Managers
Management and Statistics Professionals
Professionals in the Pharma, Biotech, and Medical Device Industries
Data Managers and Scientists
professional keen on enhancing their Excel competency and understanding of its
use in an FDA-regulated environment.
Whether you're responsible for creating or validating spreadsheet applications, managing product compliance, or overseeing data management in clinical trials, this webinar can enhance your proficiency and ensure your work aligns with FDA regulations.
David Nettleton Computer System Validation’s principal, David Nettleton is an industry leader, author, and teacher for 21 CFR Part 11, Annex 11, HIPAA, EU General Data Protection Regulation (GDPR), software validation, and computer system validation.
Mr. Nettleton 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.
Mr. Nettleton 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.