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 code describes the basic requirements for validating and documenting ER/ES capability in systems used in an FDA-regulated environment.
FDA’s recent focus on data integrity during computer system validation inspections and audits has brought this issue to the forefront of importance for compliance of systems used to support clinical trials. These include clinical trial data collection, management and reporting systems, clinical trial sample manufacturing, testing and labeling systems, and all of those systems used in the conduct of the clinical trial which generate documentation for the clinical Trial Master File (TMF).
Why You Should Attend:
We will explore the best practices and strategic approach for evaluating computer systems used in the conduct of clinical trials and determining the level of compliance, based on validation and data integrity. We will walk through the entire System Development Life Cycle (SDLC) approach to validation of FDA-regulated computer systems, and will also discuss 21 CFR Part 11 and the importance of managing electronic records and signatures appropriately.
We will also walk through the entire set of essential clinical trial files that must be maintained before, during and after completion of the trial in the Trial Master File (TMF). This part of the discussion will also delve into the use of electronic Trial Master File (eTMF) systems and the pros and cons of doing so.
Finally, we will discuss what is needed to prepare for an FDA inspection of computer systems and data used in support of clinical trials. These are extremely valuable assets for any company doing this type of work, and best efforts are necessary to ensure data is maintained in a state of integrity throughout its lifecycle.
Areas Covered in the Session :
Learn how to identify “GxP” Systems
Discuss the Computer System Validation (CSV) approach based on FDA requirements
Learn about the System Development Life Cycle (SDLC) approach to validation
Discuss the best practices for documenting computer system validation efforts, including requirements, design, development, testing and operational maintenance procedures
Understand how to maintain a system in a validated state through the system’s entire life cycle
Learn how to assure the integrity of clinical data that supports trial work
Discuss the importance of “GxP” documentation that complies with FDA requirements
Learn about the policies and procedures needed to support your validation process and ongoing maintenance of your clinical trial systems in a validated state
Understand the key components of 21 CFR Part 11 compliance for electronic records and signatures
Know the regulatory influences that lead to FDA’s current thinking at any given time
Learn how to prepare the essential files for a Trial Master File
Understand how an electronic Trial Master File (eTMF) can improve trial management
Know the clinical data files that are essential to collect before, during and after the conduct of a trial
Learn how to best prepare for an FDA inspection or audit of a clinical trial related computer system
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:
Clinical Data Analysts
Clinical Data Managers
Clinical Trial Sponsors
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 seminar will also benefit any consultants working in the life sciences industry who are involved in computer system implementation, validation and compliance