Good Documentation Practices to Support FDA Computer System Validation - By Compliance Global Inc

Overview:

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 webinar on computer system validation regulated by FDA, describes the basic requirements for validating and documenting ER/ES capability in systems.

Why Should You Attend:

You should attend this webinar training on computer system validation regulated by FDA, if you are responsible for planning, executing or managing the validation of a system. This is true whether using a "wet" or ink-based signature, or an electronic signature. It is also true whether maintaining paper-based or electronic records. Different requirements pertain to each type of signature or record, and there is a specific set of best practices that need to be followed for either type.

Effective and compliant computer system validation is critical to any pharmaceutical or FDA-regulated organization. During the past 30 years, best practices that have been developed will ensure that the cost of building and managing a computer system validation program will be minimized.

Areas Covered in this Webinar:

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

Learning Objectives:

Get an understanding of computer system validation planning, execution and management concepts, in terms of how these efforts are to be adequately documented to meet FDA requirements

Understand the steps required for documenting the validation process, along with the key documentation associated with maintaining the systems in a validated state, while minimizing costs

Get a good grasp of how to leverage these practices across all systems by creating a standardized program

Who Will Benefit:

Information Technology Analysts

QC/QA Managers and Analysts

Clinical Data Managers and Scientists

Analytical Chemists

Compliance Managers

Lab Managers

Automation Analysts

Computer System Validation Specialists

GMP Training Specialists

Business Stakeholders 

Consultants in the Life Sciences Industry

For more information, please visit : https://complianceglobal.us/product/700421/CarolynTroiano/FDA-computer-system-validation/1

Email: support@complianceglobal.us 

Toll Free: +1-844-746-4244

Tel: +1-516-900-5515

Level: 

Intermediate

Speaker Profile:

Carolyn Troiano has more than 30 years of experience in computer system validation in the pharmaceutical, medical device, animal health, tobacco and other FDA-regulated industries. She is currently an independent consultant, advising companies on computer system validation and large-scale IT system implementation projects.

During her career, Carolyn worked directly, or on a consulting basis, for many of the larger pharmaceutical companies in the US and Europe. She developed validation programs and strategies back in the mid-1980s, when the first FDA guidebook was published on the subject, and collaborated with FDA and other industry representatives on 21 CFR Part 11, the FDA’s electronic record/electronic signature regulation.

Carolyn has participated in industry conferences, providing very creative and interactive presentations. She is currently active in the PMI, AITP, RichTech, and volunteers for the PMI’s Educational Fund as a project management instructor for non-profit organizations.