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Validity : 18th Apr'24 to 28th Apr'24
Good Documentation Practices (GDPs) for FDA-Regulated Computer Systems
- 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
Overview of the webinar
We will discuss the importance of applying industry best practices when documenting the validation process for a computerized system used in an FDA-regulated environment (i.e., the system "touches" product during the manufacturing, testing or distribution process). Such a system must be validated in accordance with FDA guidelines for computerized systems and documented accordingly.
This course will describe the best practices for documenting validation work, including "who" should be responsible for such tasks and "how" the documentation should be accomplished. FDA guidelines are very specific in terms of how this is to be done.
In addition, we will touch on elements of electronic records and electronic signatures (ER/ES, or FDA 21 CFR Part 11). Specific criteria must be met in order to consider such a signature as valid in the eyes of FDA regulators.
Who should attend?
- 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
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.
There is an enormous body of documentation and information available that can be overwhelming. This course will provide a condensed overview of the practices that deliver the best results by directing the attendees to the most critical and cost-effective of methods, techniques and tools available for appropriate documentation of the validation process.
Faculty - Ms.Carolyn Troiano
Carolyn Troiano has more than 30 years of experience in computer system validation in the pharmaceutical, medical device, animal health and other FDA-regulated industries. She is currently managing a large, complex data migration, analytics and reporting program at a major financial institution.
During her career, Carolyn worked directly, or as a consultant, for many top-tier pharmaceutical companies in the US and Europe. She was responsible for computer system validation across all GxP functions at a major pharmaceutical company. Carolyn developed validation programs and strategies back in the mid-1980s, when FDA guidelines were first issued. She was an industry reviewer for 21 CFR Part 11, the FDA's electronic record/electronic signature (ER/ES) regulation. She has taught ER/ES compliance, along with computer system validation and risk management/compliance at a number of Fortune 100 firms. Her experience includes work with FDA-regulated systems used in all areas of research, development, manufacturing, quality testing and distribution.
Carolyn has participated in industry conferences, providing very creative and interactive presentations. She is currently active in the Association of Information Technology Professionals (AITP), and Project Management Institute (PMI) chapters in the Richmond, VA area. Carolyn also volunteers for the PMI's Educational Fund as a project management instructor for non-profit organizations.