The “CSV and Data Integrity for Clinical Trials Regulated by FDA” training has been added to ResearchAndMarkets.com’s offering.
The course will explore 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.
It will 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.
To 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.
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).
Agenda
Day 1
Lecture 1:
- “GxP” Systems
- Computer System Validation (CSV)
- CSV Maintenance
Lecture 2:
- “GxP” Documentation Principles
- Policies and Procedures
Lecture 3:
- 21 CFR Part 11 Overview
- 21 CFR Part 11 Compliance
- FDA Regulatory Compliance
Day 2
Lecture 4:
- Computers and Data Integrity
- Regulatory Influences
- Industry Best Practices
Lecture 5:
- Clinical Trial Master File (TMF)
- Electronic Trial Master File (eTMF)
- Trial Master File Content
- Before the Clinical Trial Begins
- During the Clinical Trial
- After the Clinical Trial
Lecture 6:
- Prepare for a Computer System Audit
For more information about this training visit here.
