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Computer system validation has been regulated by FDA for more than 30 years, used in the pharmaceutical, biotechnology, medical device, and other FDA-regulated industries for manufacturing, testing, and distributing products. This validation process encompasses thorough planning, implementation, integration, testing, and management of computer systems used to collect, analyze, and report data.
Guidelines established by the FDA in 1997, disseminated through 21 CFR Part 11, introduced the concept of electronic records and electronic signatures (ER/ES) and set out the basic requirements for validating and documenting their capability in systems used in FDA-regulated environments.
In recent years, the FDA has shifted its focus to data integrity during computer system validation inspections and audits, making it a crucial aspect of compliance for systems supporting clinical trials. These include systems for clinical trial data collection, management, and reporting, as well as those used for clinical trial sample manufacturing, testing, and labeling, and all systems generating documentation for the clinical Trial Master File (TMF).
Why You Should Attend:
In this seminar, we will cover the best practices and strategic approaches for evaluating computer systems used in clinical trials and determining their level of compliance based on validation and data integrity. We will take a deep dive into the System Development Life Cycle (SDLC) approach to validating FDA-regulated computer systems and explore the importance of managing electronic records and signatures in compliance with 21 CFR Part 11.
Additionally, we will examine the set of essential clinical trial files that must be maintained before, during, and after trial completion in the Trial Master File (TMF). Our discussion will also include the use of electronic Trial Master File (eTMF) systems, weighing the pros and cons of using such systems.
Finally, we will discuss the necessary preparations for an FDA inspection of computer systems and data used in support of clinical trials. These systems and data are critical assets for any company conducting clinical trials, and maintaining data integrity throughout its lifecycle is crucial for success.
|SEMINAR OBJECTIVES||WHO SHOULD ATTEND|
This seminar is intended for those involved in clinical trial planning, execution and support, working in the FDA-regulated industries, including pharmaceutical, medical device, biological and tobacco. Functions that are applicable include research and development, manufacturing, Quality Control, distribution, clinical testing and management, clinical sample labeling, adverse events management and post-marketing surveillance.
You should attend this seminar if you are responsible for planning, executing or managing the implementation of any system governed by FDA regulations that is used to conduct, manage or support the conduct of clinical trials, or if you are maintaining or supporting such a system. Examples of who will benefit from this webinar include:
DAY 1 (10 AM to 3 PM)
DAY 2 (10 AM to 3 PM)
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.