Purchase any WEBINAR and get
10% Off
CODE: SAVE10
T&C applicable, please referFAQ
Validity : 20th Apr'24 to 30th Apr'24
Good Documentation Practices to Support FDA Computer System Validation and Compliance
- Computer System Validation (CSV) and the System Development Life Cycle (SDLC) Methodology
- GxP - Good Manufacturing, Laboratory and Clinical Practices
- 21 CFR Part 11, Electronic Records/Electronic Signatures (ER/ES)
- Data Archival to ensure security, integrity and compliance
- Learn the requirements for documenting efforts related to systems governed by FDA
- Discuss the best practices for documenting computer system validation efforts, including requirements, design, development, testing and operational maintenance procedures
- Review examples of incorrect, incomplete or otherwise inappropriate and non-compliant documentation and understand why these are not acceptable
- Learn how to prepare a procedure that will capture the best practices for FDA compliant documentation
- Discuss the importance of training as it relates to good documentation practices to ensure FDA compliance
- Q&A
Overview of the webinar
As a “GxP” system, following Good Manufacturing, Laboratory and Clinical Practices, the computer system must be validated in accordance with FDA requirements. If electronic records and/or electronic signatures (ER/ES) are incorporated into the system, FDA’s CFR Part 11 guidance on ER/ES must be followed.
This webinar will help you understand the FDA’s requirements for good documentation, including how to handle change control and the importance of audit trails. We will also cover the importance of maintaining the documentation from every computer system validation effort in a “current” state. The system must be maintained in a validated state throughout its entire life cycle and the accompanying validation documentation must also be maintained.
Who should attend?
- 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
Why should you attend?
FDA requires that all computer systems that handle data regulated by the Agency to be validated in accordance with their guidance on computerized systems. In 1997, 21 CFR Part 11 was issued to address electronic records and signatures, as many laboratories and other FDA-regulated organizations began seeking ways to move into a paperless environment.
This session will address the specific way of documenting your computer system validation work to ensure it meets FDA requirements and can pass an inspection. There are specific requirements that must be followed in order for the Agency to consider the documentation valid and without following these, there is a great risk of invalidating work.
Faculty - Ms.Carolyn Troiano
Carolyn Troiano has more than 30 years of experience in computer system validation in the pharmaceutical, medical device, animal health and other FDA-regulated industries. She is currently managing a large, complex data migration, analytics and reporting program at a major financial institution.
During her career, Carolyn worked directly, or as a consultant, for many top-tier pharmaceutical companies in the US and Europe. She was responsible for computer system validation across all GxP functions at a major pharmaceutical company. Carolyn developed validation programs and strategies back in the mid-1980s, when FDA guidelines were first issued. She was an industry reviewer for 21 CFR Part 11, the FDA's electronic record/electronic signature (ER/ES) regulation. She has taught ER/ES compliance, along with computer system validation and risk management/compliance at a number of Fortune 100 firms. Her experience includes work with FDA-regulated systems used in all areas of research, development, manufacturing, quality testing and distribution.
Carolyn has participated in industry conferences, providing very creative and interactive presentations. She is currently active in the Association of Information Technology Professionals (AITP), and Project Management Institute (PMI) chapters in the Richmond, VA area. Carolyn also volunteers for the PMI's Educational Fund as a project management instructor for non-profit organizations.