Computer System Validation
With the ever increasing dependency on computerized systems and the rapid grown in the ever changing technology advancements in computerized systems, it becomes even more important to ensure that compliance standards in this regulated industry are implemented and maintained. Doing so, is the challenge.The quality of electronic systems for manufacturing, laboratory and clinical use is carefully regulated and there is a need to gain a greater understanding of what if required by the FDA. This course is designed to assist firms to identify the validation requirements for quality critical and business critical applications and computerized systems while reducing costs through proper risk analysis techniques and the implementation of templates for standards.This 75 minute webinar will focus on the minimum requirements for proving validation compliance standards for many of the applications and computerized systems utilized in the regulated industry and to develop practical solutions for integrating the quality assurance of computerized systems and electronic data into everyday business operations.This course will address in detail the process for successfully managing, gathering, analyzing, specifying and documenting validation and for implementing the 21 CFR 11 regulations, which affects all aspects of computerized systems used in the pharmaceutical industry.
• Regulatory Requirements (FDA and EU)• Perspective from the FDA: 21 CFR Part 11 Compliance and Computer Validation • Risk Analysis - Determine Which Systems Need to be Validated • Software Validation Requirements for: • Spreadsheets • Production Equipment • Lab Equipment • Data Migration • User Requirement Specifications (URS) • Design Specifications • Compiling the Validation Master Plan (VMP) • Qualification Requirements (IQ,OQ, PQ) • Preparing Validation Summary Reports • Requirements for Off the Shelf (OTS) Software • Validation Planning and Project Management • Effective Software Testing • Auditing GxP Computer Systems • Auditing Software Vendors • Assessing the Impact of Software Changes• Q
• Information Technology• Quality Assurance • Quality Control • Laboratory Staff • Managers • GMP, GCP, GLP Professionals• Regulatory Affairs • Trainers