Good Documentation Practices (GDPs) for FDA-Regulated Computer Systems

As a “GxP” system, following Good Manufacturing, Laboratory and Clinical Practices, the computer system must be validated in accordance with FDA requirements.  If electronic records and/or electronic signatures (ER/ES) are incorporated into the system, FDA’s CFR Part 11 guidance on ER/ES must be followed.

This webinar will help you understand the FDA’s requirements for good documentation, including how to handle change control and the importance of audit trails.  We will also cover the importance of maintaining the documentation from every computer system validation effort in a “current” state.  The system must be maintained in a validated state throughout its entire life cycle, and the accompanying validation documentation must also be maintained.

• Computer System Validation (CSV) and the System Development Life Cycle (SDLC) Methodology
• “GxP” – Good Manufacturing, Laboratory and Clinical Practices
• 21 CFR Part 11, Electronic Records/Electronic Signatures (ER/ES)
• Data Archival to ensure security, integrity and compliance
• Learn the requirements for documenting efforts related to systems governed by FDA
• Discuss the best practices for documenting computer system validation efforts, including requirements, design, development, testing and operational maintenance procedures.
• Review examples of incorrect, incomplete, or otherwise inappropriate and non-compliant documentation and understand why these are not acceptable
• Learn how to prepare a procedure that will capture the best practices for FDA compliant documentation
• Discuss the importance of training as it relates to good documentation practices to ensure FDA compliance

This webinar is intended for those working in the FDA-regulated industries, including pharmaceutical, medical device, biological, animal health and tobacco. Functions that are applicable include research and development, manufacturing, Quality Control, distribution, clinical testing and management, adverse events management and post-marketing surveillance. You should attend this webinar if you are responsible for planning, executing or managing the implementation of any system governed by FDA regulations, or if you are maintaining or supporting such a system.

• Information Technology Analysts
• QC/QA Managers
• QC/QA Analysts
• Clinical Data Managers
• Clinical Data Scientists
• Analytical Chemists
• Compliance Managers
• Laboratory Managers
• Automation Analysts
• Manufacturing Managers

Carolyn Troiano has more than 35 years of experience in computer system validation 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. She is currently building an FDA computer system validation compliance strategy at a vapor company. Carolyn has participated in industry conferences, and is currently active in the Association of Information Technology Professionals (AITP), and Project Management Institute (PMI) chapters in the Richmond, VA area. Carolyn also volunteers for the PMI’s Educational Fund as a project management instructor for non-profit organizations.