Two-Day Virtual Course: CSV and Data Integrity for FDA-Regulated Clinical Trials – August 15-16, 2022 –

DUBLIN–(BUSINESS WIRE)–“CSV and Data Integrity for FDA Regulated Clinical Trials” training has been added to from offer.

The course will explore best practices and the strategic approach to assess IT systems used in the conduct of clinical trials and determine the level of compliance, based on validation and data integrity.

We will review the entire System Development Life Cycle (SDLC) approach to validation of FDA-regulated computer systems, and also discuss 21 CFR Part 11 and the importance of managing records. and electronic signatures appropriately.

He will review all essential clinical trial records that must be kept before, during and after the end of the trial in the Trial Master File (TMF). This part of the discussion will also look at the use of electronic Trial Master File (eTMF) systems and the pros and cons of such use.

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 every effort is needed to ensure that the data is maintained in a state of integrity throughout its lifecycle.

Validation of computer systems has been regulated by the FDA for more than 30 years as it pertains to systems used in the manufacturing, testing, and distribution of a product in the pharmaceutical, biotechnology, medical device, or other industries. regulated by the FDA. 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 the FDA in 1997 and disseminated through 21 CFR Part 11. This code outlines the basic requirements for validating and documenting the ER/ES capability in systems used in an FDA-regulated environment.

The FDA’s recent emphasis on data integrity during inspections and validation audits of computer systems has brought this issue to the forefront of compliance importance for 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 systems used in the conduct of the clinical trial that generate documentation for the Clinical Trial Master File (TMF).


Day 1

Course 1:

Course 2:

  • Principles of “GxP” documentation

  • Policies and Procedures

Course 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 Test Master File (eTMF)

  • Contents of main test file

  • Before the start of the clinical trial

  • During the clinical trial

  • After the clinical trial

Lecture 6:

  • Preparing for an IT system audit

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