2024 - Current Trends in FDA Compliance and Enforcement for Regulated Computer Systems and Data

FDA Compliance and Enforcement for Regulated Computer Systems and Data 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.
This instructor-led live training webinar will discuss what FDA requires that all computer systems that handle data regulated by the Agency to be validated in accordance with their guidance on computerized systems. This guidance was first issued in 1983, and the main points of focus remain consistent today, despite the number of years that have passed and the technology changes that have taken place.
The guidance was revisited for its application to the medical device industry, as the first issuance addressed pharmaceuticals. 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 guidance has been modified over the years to make it more palatable to industry, and this includes discretionary enforcement measures. The intent was to avoid creating a huge regulatory compliance cost to industry that was initially preventing companies from embracing the technology.
Why Should You Attend
This session will provide some insight into current trends in compliance and enforcement. Some are based on technology changes, and these will continue to have an impact as new innovations come into use in the industry.
Provide an overview of FDA computer system validation requirements, including 21 CFR Part 11 compliance
Provide an overview of recent trends in FDA compliance and enforcement relative to computer system validation, including citations
Provide a set of best practices and industry standards to meet FDA compliance requirements for computer system validation
Webinar Takeaway
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
Validation Strategy that will take into account the system risk assessment and system categorization (GAMP V) processes
Recent FDA findings for companies in regulated industries
Recent trends in technology that need to be addressed in the CSV approach
Q&A
Who Will Benefit
The following individuals or disciplines will benefit from attending this Webinar:
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