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Good Documentation Practices to Support FDA Computer System Validation and Compliance

Friday, 22 June 2018  11:30 AM PDT, 02:30 PM EDT

Training Duration = 75 min                  Sponsored by Online Compliance Panel

Click Here to register $250.00

Click Here to register and receive CD recording $500.00

Computer system validation has been regulated by FDA for more than 35 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 documentation meets the Agency's standards.

Learning 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

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.

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.

Topics

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.

Instructor

Carolyn Troiano has more than 35 years of experience in the pharmaceutical, medical device, tobacco 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, developing and executing compliance strategies and programs.