2024 - FDA Compliance and Laboratory Computer System Validation

FDA Compliance and Laboratory Computer System Validation Course Description
This live training webinar includes the following for each registered attendee:
A copy of the presentation slides by download
A certificate of participation for attendee training records
Q/A Session
Free Handouts on IT Vendor Questionnaire, which would be used when auditing a vendor of products and services used in FDA-regulated systems
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.
In the early 2000s, FDA recognized they could not inspect every computer system at every regulated company and placed the onus on industry to begin assessing all regulated computer systems based on risk. The level of potential risk, should the system fail to operate properly, needed to be the basis for each company’s approach to developing a validation approach and rationale as part of the planning process. System size, complexity, business criticality, GAMP 5 category and risk rating are the five key components for determining the scope and robustness of testing required to ensure data integrity and product safety.
We will explore the best practices and strategic approach for evaluating computer systems used for laboratory activities in the conduct FDA-regulated activities and determining the level of potential risk, should they fail, on data integrity, process and product quality, and consumer/patient safety. We will walk through the System Development Life Cycle (SDLC) approach to validation, based on risk assessment, and will also discuss 21 CFR Part 11 and the importance of managing electronic records and signatures appropriately.
This live training webinar will walk you through the entire set of essential policies and procedures, as well as other supporting documentation and activities that must be developed and followed to ensure compliance. We will provide an overview of practices to prepare for an FDA inspection, and will also touch on the importance of auditing vendors of computer system hardware, software, tools and utilities, and services.
Finally, we will provide an overview of industry best practices, with a focus on data integrity and risk assessment that can be leveraged to assist in all your GxP work.
Webinar Takeaway
Gain an understanding of laboratory system computer validation planning, execution and management concepts
Discuss the best practices for laboratory computer system validation that will ensure compliant results while minimizing costs
Identify the GAMP 5 category for the system to understand how best to approach validation, particularly testing
Discuss the key documentation associated with validating laboratory systems and maintaining them in a validated state, while minimizing costs
Learn how to leverage these practices across all systems by creating a standardized program for FDA-regulated systems
Understand the training that must be provided to business and IT staff involved in the validation process
Discuss the business process re-engineering opportunities that might be leveraged as a system is implemented, particularly if it is more advanced than the legacy system in terms of technology and functionality
Learn the advantage of incorporating a formal organizational change management system into the validation effort to ensure that users fully embrace the new technology and functionality
Q&A
Who Will Benefit
This webinar is intended for those working in the FDA-regulated industries, including pharmaceutical, medical device, biological, animal health and tobacco. Functions that are applicable include research and development, manufacturing, Quality Control, distribution, clinical testing and management, adverse events management and post-marketing surveillance.
Personnel in the following roles will benefit:
Information Technology Analysts
Information Technology Developers and Testers
Software Quality Assurance Professionals
QC/QA Managers and Analysts
Analytical Chemists
Compliance and Audit Managers
Laboratory Managers
Automation Analysts
Manufacturing Specialists and Managers
Supply Chain Specialists and Managers
Regulatory Affairs Specialists
Regulatory Submissions Specialists
Risk Management Professionals
Clinical Data Analysts
Clinical Data Managers
Clinical Trial Sponsors
Computer System Validation Specialists
GMP Training Specialists
Business Stakeholders/Subject Matter Experts
Business System/Application Testers
Vendors responsible for software development, testing and maintenance
Vendors and consultants working in the life sciences industry who are involved in computer system implementation, validation and compliance