Good Documentation Practice (GDP) and FDA Validation Compliance for Regulated Computer Systems and Data

Computer system validation has been regulated by FDA for more than 30 years, as it relates to systems used in the manufacturing, testing and distribution of a product in the pharmaceutical, biotechnology, medical device or other FDA-regulated industries. The FDA requirements ensure thorough planning, implementation, integration, testing and management of computer systems used to collect, analyze and/or report data. Electronic records and electronic signatures (ER/ES) came into play through guidelines established by FDA in 1997, and disseminated through 21 CFR Part 11. This code describes the basic requirements for validating and documenting ER/ES capability in systems used in an FDA-regulated environment.

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.

Why Should You Attend:

FDA requires that all computer systems that handle data regulated by the Agency to be validated in accordance with their guidance on computerized systems. In 1997, 21 CFR Part 11 was issued to address electronic records and signatures, as many laboratories and other FDA-regulated organizations began seeking ways to move into a paperless environment.

This session will address the specific way of documenting your computer system validation work to ensure it meets FDA requirements and can pass an inspection. There are specific requirements that must be followed in order for the Agency to consider the documentation valid, and without following these, there is a great risk of invalidating work.

Areas Covered in the Webinar:

This webinar includes the following key objectives:

• 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
• Q&A

Who Will Benefit:

This webinar is intended for those working in the FDA-regulated industries, including pharmaceutical, medical device, biologics, tobacco and tobacco-related products (e-liquids, e-cigarettes, pouch tobacco, cigars, etc.). Functions that are applicable include research and development, manufacturing, Quality Control, distribution, clinical testing and management, sample labeling, adverse events management and post-marketing surveillance.

Examples of who will benefit from this webinar include:

• Information Technology Analysts
• Information Technology Developers and Testers
• 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
• Legal Professionals
• Compliance Professionals