Faculty: Carolyn Troiano ‎ ‎ ‎ ‎ ‎‎ ‎ ‎ |‎ ‎ ‎ ‎ ‎ ‎ ‎ ‎ ‎ Code: FDB3644


  • Date: 3/13/2024 11:00 AM - 3/13/2024 12:30 PM
  • Time zone: Eastern Time (US/Canada) Online Event

 

Description

Discover the strategic approach and best practices for evaluating Excel spreadsheets used in FDA-regulated activities. We'll assess the potential risks associated with spreadsheet failures on data integrity, process quality, and safety. Explore the System Development Life Cycle (SDLC) validation approach, emphasizing risk assessment, and delve into the significance of managing electronic records and signatures according to 21 CFR Part 11.

Our webinar will guide you through the validation process for Excel spreadsheets used in FDA-regulated tasks. Excel, categorized as a GAMP 5 Category 1 system during installation, must be handled with precision. However, once macros or custom functionalities are added, it becomes a GAMP 5 Category 5 system, necessitating validation to ensure accurate coding.

We'll detail the planning and validation activities required for custom Excel applications. While full validation, including Installation Qualification (IQ) and Operational Qualification (OQ), is essential, we'll streamline the process. Learn how to define and test requirements, incorporate system suitability with input from Subject Matter Experts (SMEs), and ensure compliance with FDA validation, Part 11, and data integrity requirements.

Explore the creation of essential policies, procedures, and supporting documentation for spreadsheet compliance. Maintain your validated spreadsheet application effectively and prepare for FDA inspections with our insights.

Additionally, gain insights into industry best practices, focusing on data integrity and risk assessment, to enhance your GxP operations.

Areas Covered in the Session :

  • 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 Should Attend:

  • Information Technology (IT) Analysts
  • IT Developers
  • IT Support Staff
  • IT Security Staff
  • QC/QA Managers and Analysts
  • Production Managers and Supervisors
  • Supply Chain Managers and Supervisors
  • Clinical Data Managers and Scientists
  • Compliance Managers and Auditors
  • Lab Managers and Analysts
  • Computer System Validation Specialists
  • GMP, GLP, GCP Training Specialists
  • Business Stakeholders using Computer Systems regulated by FDA
  • Regulatory Affairs Personnel
  • Consultants in the Life Sciences and Tobacco Industries
  • Interns working at the companies listed above



Course Director: CAROLYN TROIANO

 

Carolyn Troiano has more than 30 years of experience in computer system validation in the pharmaceutical, medical device, animal health, 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.

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.

Carolyn has participated in industry conferences. She is currently active in the PMI, AITP, and RichTech, and volunteers for the PMI’s Educational Fund as a project management instructor for non-profit organizations.