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

• OVERVIEW

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.

• LEARNING OBJECTIVES

• 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

• WHY SHOULD YOU ATTEND

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.

• WHO WILL BENEFIT?

• 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