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
Faculty Carolyn Troiano
Midlothian, Virginia, United States
Carolyn Troiano has more than 40 years of experience in computer system validation and compliance in the pharmaceutical, medical device, 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.
