Overview:
Companies engaged
in human clinical trials must comply with specific regulatory requirements.
This includes maintaining a Trial Master File (TMF), which stores essential
documents, content, and images related to the trial. The TMF is crucial as it
contains all documentation needed to demonstrate a sponsor's adherence to their
obligations in conducting a clinical trial.
According to the
Code of Federal Regulations (21 CFR 312.50), sponsors are responsible for
ensuring that investigations are conducted following the general
investigational plan and protocols in the Investigational New Drug (IND)
application. Similarly, the European Directive 2005/28/EC mandates that the TMF
should consist of essential documents, allowing both the conduct of the
clinical trial and the evaluation of the data quality.
The International
Conference on Harmonization (ICH) Good Clinical Practice (GCP) Section 8.1
describes these 'essential documents' as those that permit evaluation of the
trial's conduct and the data produced. In 1996, the ICH published a
consolidated guidance for industry on GCP, aiming to provide a unified standard
for the United States, European Union, and Japan, thus facilitating mutual
acceptance of clinical data by regulatory authorities in these jurisdictions.
While the US FDA
does not specifically require a TMF, adherence to ICH GCP, which is often a
regulatory requirement, implicitly necessitates creating and maintaining a TMF.
These documents must be readily available for inspection by regulatory
authorities during and after the trial and support product approval requests
for pharmaceuticals, biologics, and medical devices.
The FDA's recent
draft guidance on electronic records and signatures (March 2023) offers
insights into the use of electronic systems, records, and signatures in
clinical investigations. This guidance revises the June 2017 draft and, upon
finalization, will supersede the May 2007 guidance on Computerized Systems Used
in Clinical Investigations. It details the requirements under which the FDA
considers electronic systems, records, and signatures as trustworthy and
equivalent to paper records. While providing clarification, it introduces no
new industry requirements and represents the FDA’s current stance on the
subject.
Areas Covered
during the session:
- GxP Data and
Computer Systems Regulated by FDA
- Computer System
Validation (CSV)
- The System
Development Life Cycle (SDLC) Methodology
- Risk Assessment
- GAMP®5 Software
Categorization
- Validation Strategy
and Planning
- Functional
Requirements Specification (FRS)
- Design/Configuration
Specifications
- Installation
Qualification (IQ)
- Operational
Qualification (OQ)
- Performance
Qualification (PQ)
- System Acceptance
and Notification of Release into Production
- Maintenance and
Operational Support of FDA-Regulated Computer Systems
- Policies and
Procedures to Support CSV
- Training and
Organizational Change Management (OCM) Supporting CSV Activities
- 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
- Electronic TMF
(eTMF)
Why should you
attend?
Navigating the
complexities of FDA regulations for clinical trials and data systems is a
critical challenge facing professionals in the pharmaceutical, biotech, and
medical device industries. This webinar is an essential guide to mastering the
key areas of GxP Data, Computer System Validation (CSV), and the System
Development Life Cycle (SDLC), which are pivotal in ensuring compliance with
FDA standards.
Are you fully
prepared to implement and maintain a Trial Master File (TMF) that meets the
stringent requirements of the FDA? Do you understand how to effectively
categorize software under GAMP®5 and develop a robust validation strategy? This
webinar will provide you with the expertise to confidently address these
questions.
You’ll gain
insights into creating detailed Functional Requirements Specifications,
ensuring your installation, operational, and performance qualifications are
conducted flawlessly, and maintaining FDA-regulated computer systems with
precision. We’ll also delve into the recent draft guidance from the FDA on
electronic records and signatures, a critical aspect for anyone involved in
clinical investigations.
Whether you’re in
charge of validating computer systems, managing clinical data, or ensuring
regulatory compliance, this webinar will equip you with the essential knowledge
and skills to excel in your role. Attend to stay ahead in the demanding field
of FDA-regulated clinical trials and data management.
What industries
will benefit from this training?
Manufacturing,
Testing, Packaging and Distribution companies in the following industries that
are regulated by FDA are required to follow GxPs:
- Pharmaceutical (for
drug products introduced using a medical device)
- Medical Device
- Biologicals (for
biological products introduced using a medical device)
- Tobacco (based on
the Tobacco Control Act of 2009)
- E-Liquid/Vapor
(based on the “Deeming” Act of 2016)
- E-Cigarette (based
on the “Deeming” Act of 2016)
- Cigar (based on the
“Deeming” Act of 2016)
- Third-Party
companies that support those in the above industries, including Contract
Research Organizations (CROs)
- Colleges and
Universities offering programs of study in Clinical Trial Management and
Regulatory Affairs/Matters related to FDA
Who will benefit?
Personnel in the
following roles will benefit:
- Information
Technology Analysts
- QC/QA Managers
- QC/QA Analysts
- Clinical Data
Managers
- Clinical Data
Scientists
- Analytical Chemists
- Compliance Managers
- Laboratory Managers
- Automation Analysts
- Manufacturing
Managers
- Manufacturing
Supervisors
- Supply Chain
Specialists
- Computer System
Validation Specialists
- GMP Training
Specialists
- Business
Stakeholders responsible for computer system validation planning, execution,
reporting, compliance, maintenance and audit
- Consultants working
in the life sciences industry who are involved in computer system
implementation, validation and compliance
- Auditors engaged in the internal inspection of labeling records and practices.
Carolyn Troiano has more than 40 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.
During her career, Carolyn worked directly, or on a consulting basis, for many of the larger pharmaceutical companies in the US and Europe. She developed validation programs and strategies back in the mid-1980s, when the first FDA guidebook was published on the subject, and collaborated with FDA and other industry representatives on 21 CFR Part 11, the FDA’s electronic record/electronic signature regulation
Carolyn has participated in industry conferences. She is currently active in the PMI, AITP, and RichTech, and volunteers for the PMI’s Educational Fund as a project management instructor for non-profit organizations.
Enrollment Options
Tags: FDA 21 CFR Part 11, Clinical Trials Compliance, CSV and SDLC, TMF Guidelines, GxP Data, Regulatory Webinar, Electronic Recordkeeping, Compliance Training 2024, FDA Regulatory Standards, Clinical Research Management, February 2024, Carolyn, Troiano