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

Faculty :

Industry :

Duration :

Course Description:

         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 Good Documentation Practices 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 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.

         In preparing all of the Computer System Validation (CSV) deliverables, it is necessary to document the work in compliance with FDA requirements. You will learn about the best practices for ensuring your Good Documentation Practices meets the Agency's standards.

Why should you Attend?

         This Good Documentation Practices 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 GDPs 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.

         You will learn the best practices for ensuring that all of your Computer System Validation (CSV) deliverables and documentation are prepared in accordance with FDA requirements and meet compliance guidelines.

Areas Covered:

This 90 mins GDPs course will include:
  • 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?

Individuals with the following roles in an FDA-regulated organization will benefit from this GDPs webinar:

  • Information Technology Analysts
  • Information Technology Developers and Testers
  • QC/QA Managers and Analysts
  • Analytical Chemists
  • Compliance and Audit Managers
  • Laboratory Managers
  • Automation Analysts
  • Computer System Validation Specialists
  • GMP Training Specialists
  • Business Stakeholders/Subject Matter Experts
  • Business System/Application Testers

This webinar will also benefit any consultants working in the life sciences industry who are involved in computer system implementation, validation and compliance.


Target Industries/Associations/Societies
  • Pharmaceutical
  • Biotechnology
  • Medical Device
  • Tobacco
  • e-Liquid/Vapor
  • Cigar

Any company regulated by FDA, or doing work that is governed by FDA requirements. This includes consulting firms, vendors and others.

Registration Options


Avail 12 months unlimited access for a single user.


Material shipped within 15 days post webinar completion & get life time access for unlimited participants.



Tags


Good Documentation Practices, FDA Regulated Computer Systems, FDA Requirements, Computer System Validation, FDA Regulated Industries, Clinical Testing and Management, FDA's requirements for Good Documentation

Speaker Details

Carolyn  Troiano

Carolyn Troiano

FDA/Medical Device Consultant

Carolyn Troiano  has more than 35 years of experience in computer system validation and compliance in the pharmaceutical, medical device, tobacco and other FDA-regulated industries.  

Refund Policy



Participants/Registrants for our live events, may cancel up to 72 hours prior to the start of the live session and ComplyArena will issue a letter of credit to be used towards any of ComplyArena's future events. The letter of credit will be valid for 12 months.

ComplyArena will process refund in cases where the event has been cancelled and is not rescheduled within 90 days from the original scheduled date of the webinar. In case if a live webinar is cancelled, participants/registrants may choose between recorded version of the course or a refund. Refunds will not be processed to participants who do not show up for the webinar. A webinar may be cancelled due to unavoidable circumstances, participants will be notified 24 hours before the scheduled start of the event. Contact us via email: admin@complyarena.com or call +1-888-222-5917 (Toll Free).