In addition to producing a Trial Master File (TMF), companies engaged in the conduct of human clinical trials must adhere to FDA’s requirements for Computer System Validation (CSV) and Data Integrity.  In addition, they must adhere to specific government regulatory requirements. Certain documents, content and images related to a clinical trial must be stored and maintained, and depending on the regulatory jurisdiction, this body of information may be stored in a trial master file (TMF).

We will cover all aspects of CSV and the requirements for ensuring data integrity in this virtual seminar.  In particular, we will identify the CSV components and deliverables, based on the System Development Life Cycle (SDLC) Methodology.  We will cover all aspects of maintaining a system in a validated state through the entire system life cycle.

We will cover data integrity and the importance of maintaining it throughout the life cycle of the data that is FDA-regulated.  In particular, we will cover the current trends in FDA inspection and enforcement to identify areas most at risk that must be addressed during CSV and maintaining a system in a validated state to ensure data is maintained with integrity throughout its life cycle.

Why you should attend

The attendee will learn about the latest industry best practices related to data and computer systems related to a clinical trial. Data includes both structured data (e.g., database records) and unstructured data. (e.g., Excel spreadsheet, Word document, PDF file) Many systems from many sources create the structured and unstructured data that must be maintained to support a clinical trial. The source systems must be validated and maintained in a validated state, and the source data must be with complete integrity, meeting the ALCOA+ principles. (attributable, legible, contemporaneous, original or true copy, accurate, complete, consistent, enduring, available)

During this 2-day virtual seminar, the attendee will be fully capable of assessing their own systems and data for quality and compliance. We will also cover newer technologies that may be incorporated into the larger mix of clinical trial systems, such as electronic records/signatures (ER/ES), cloud, Software-as-a-Service (SaaS), mobile devices. Similarly, we will cover various approaches to validation, meaning the traditional, waterfall phased approach vs. the newer agile methodology. We’ll talk about automated testing and critical thinking, the key components of the Computer Software Assurance (CSA) draft guidance issued by FDA draft guidance issued by FDA in September 2022.

A keen understanding of systems and data will provide assurance that a clinical trial will be supported using newer technologies and following a unique approach.

Who Will Benefit

• Information Technology (IT) Analysts
• IT Developers
• IT Support Staff
• QC/QA Managers and Analysts
• Clinical Data Managers and Scientists
• Compliance Managers and Auditors
• Lab Managers and Analysts
• Computer System Validation Specialists
• GMP Training Specialists
• Business Stakeholders using Computer Systems regulated by FDA
• Regulatory Affairs Personnel
• Consultants in the Life Sciences and Tobacco Industries
• Interns working at the companies listed above
• College students attending schools and studying computer system validation, regulatory affairs/matters (related to FDA) or any other discipline that involves adherence to FDA regulatory requirements

Agenda

12 hours over 2 days
9am to 3pm Pacific each day
10:20-10:30 break
12:00-12:40 lunch
1:50-2:00 break

• Computer System Validation (CSV)
• The System Development Life Cycle (SDLC) Methodology
• Maintaining a computer system in a validated state
• Data integrity, ensuring it is maintained throughout the life cycle of the data
• Trial Master File (TMF) background and rationale
• The essential documents to include in a TMF
• Organizing and maintaining a TMF
• Standard Operating Procedure required to support TMF
• Inspection of TMF records
• Q&A