Risk-Based Validation of Spreadsheet Applications Course Description
This instructor-led live training webinar will discuss the best practices and strategic approach for evaluating Excel spreadsheets used in the conduct FDA-regulated activities and determining the level of potential risk, should they fail, on data integrity, process and product quality, and consumer/patient safety. We will walk through the System Development Life Cycle (SDLC) approach to validation, based on risk assessment, and will also discuss 21 CFR Part 11 and the importance of managing electronic records and signatures appropriately.
We will cover the approach for validating Excel spreadsheets used to conduct FDA-regulated work. Excel, as installed as a GAMP 5 Category 1 system, provides utility and must only be installed properly. However, once a user creates macros or other types of additional functionality, these turn the system into a GAMP 5 Category 5 system, which is customized. This elevates the need for validation of the spreadsheet application to ensure it has been coded correctly.
This live training webinar will walk you through the planning and validation activities required for an Excel custom application. While full validation is needed, meaning an Installation Qualification (IQ) and Operational Qualification (OQ), the work in support of validating a customized spreadsheet application can be streamlined a great deal. We’ll talk about ensuring that this validation effort is based on making sure requirements are defined, tested, and proven to be met, that system suitability is taken into account in defining test scenarios and is provided by Subject Matter Experts (SMEs), and the output confirms that the system meets FDA requirements for validation, Part 11 compliance, and data integrity compliance are met.
We will also walk through the entire set of essential policies and procedures, as well as other supporting documentation and activities that must be developed and followed to ensure compliance for a spreadsheet application. We will provide an overview of practices to best maintain the spreadsheet application in a validated state over its life, and prepare for an FDA inspection.
Finally, we will provide an overview of industry best practices, with a focus on data integrity and risk assessment, that can be leveraged to assist in all your GxP work.
Why Should You Attend
This webinar is intended for those involved in planning, execution and support of computer system validation activities, working in the FDA-regulated industries, including pharmaceutical, medical device, biologics, tobacco and tobacco-related products (e-liquids, e-cigarettes, pouch tobacco, cigars, etc.). In particular, those resources creating spreadsheet applications for functions that are applicable, such as research and development, manufacturing, Quality Control, distribution, clinical testing and management, sample labeling, adverse events management and post-marketing surveillance could benefit by learning the best way to plan and execute spreadsheet application validation, and support the spreadsheet in a validated state through its entire life.
Webinar Takeaway
- Learn how to identify spreadsheet applications that are considered to be “GxP” Systems
- Discuss the Computer System Validation (CSV) approach based on FDA requirements to ensure a spreadsheet application will meet requirements and will be suitable for its intended task(s)
- Learn about Computer Software Assurance (CSA) and how this approach may streamline your validation work
- Learn about the System Development Life Cycle (SDLC) approach to validation, and how to apply this to Excel spreadsheet applications
- Discuss the best practices for documenting computer system validation efforts for spreadsheet applications, including requirements, design, development, testing and operational maintenance procedures
- Understand how to maintain a spreadsheet application in a validated state through the system’s entire life cycle
- Learn how to assure the integrity of data that supports GxP work done using the spreadsheet application
- Learn about the policies and procedures needed to support your validation process and ongoing maintenance of your systems in a validated state
- Understand the key components of 21 CFR Part 11 compliance for electronic records and signatures
- Know the regulatory influences that lead to FDA’s current thinking at any given time
- Learn how to conduct a risk assessment on a spreadsheet application that will provide the basis for developing a validation rationale
- Learn how to best prepare for an FDA inspection or audit of a GxP spreadsheet application
- Finally, understand the industry best practices that will enable you to optimize your approach to validating spreadsheet applications, based on risk assessment, to ensure data integrity is maintained throughout the entire data life cycle
- Q&A
Who Will Benefit
The following individuals or disciplines will benefit from attending this Webinar:
- Information Technology Analysts
- Information Technology Developers and Testers
- Software Quality Assurance Professionals
- QC/QA Managers and Analysts
- Analytical Chemists
- Compliance and Audit Managers
- Laboratory Managers
- Automation Analysts
- Manufacturing Specialists and Managers
- Supply Chain Specialists and Managers
- Regulatory Affairs Specialists
- Regulatory Submissions Specialists
- Risk Management Professionals
- Clinical Data Analysts
- Clinical Data Managers
- Clinical Trial Sponsors
- Computer System Validation Specialists
- GMP Training Specialists
- Business Stakeholders/Subject Matter Experts
- Business System/Application Testers
- Vendors responsible for software development, testing and maintenance
- Vendors and consultants working in the life sciences industry who are involved in computer system implementation, validation and compliance
This live training webinar includes the following for each registered attendee:
- A copy of the presentation slides by download
- A certificate of participation for attendee training records
- Q/A Session
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Free Handouts on IT Vendor Questionnaire, which would be used when auditing a vendor of products and services used in FDA-regulated systems.
Faculty Carolyn Troiano
Midlothian, Virginia, United States
Carolyn Troiano has more than 40 years of experience in computer system validation and compliance in the pharmaceutical, medical device, tobacco and other FDA-regulated industries. She is currently an independent consultant, advising companies on computer system validation and large-scale IT system implementation projects.
