The Center for Professional Innovation & Education (CfPIE), Costa Mesa, CA
Apr 25 & 26, 2007
Who Should AttendThis course is designed for Validation, Quality, IT, and Business personnel responsible for implementing and using regulated computer systems in the pharmaceutical, biotech and medical device industries. The course is of special value to personnel seeking experience with computer validation and issues associated with FDA regulated computer systems. The course is especially designed for attendees seeking a thorough introductory level of understanding, yet is also designed to be valuable to those with prior experience seeking to remain current with industry trends and approaches. Learning Objectives The course is designed to provide a thorough understanding of computer system validation. In addition, the course will address how 21 CFR Part 11 (electronic record/electronic signature requirements) fits into the validation process. The attendee will be familiar with expected content for computer validation deliverables through examination of example documents, as well as how to develop the validation rationale for a variety of circumstances. Course Description This course focuses on developing and implementing regulated computer systems with an appropriate level of documented evidence to satisfy FDA expectations. The course targets deliverable document content and how to avoid rework and unnecessary expense through a proactive approach. The core elements of a satisfactory computer validation program will be emphasized. Topics to be discussed include: Computer Systems Validation (CSV) Process and Deliverables; Auditing GXP Computer Systems; Introduction to 21 CFR Part 11, FDA Requirements for Electronic Records and Electronic Signatures; Final Part 11 Guidance, Scope and Application; Standardized Approach to Part 11 Gap-Analysis and Remediation; Interactive Discussion and Q&A Sessions. ________________________________________ COURSE AGENDA DAY ONE Computer Validation – General Overview • Computer Validation fundamentals
• Who needs to validate?
• Why is validation necessary?
What regulations guide validation requirements?
• What is Computer Validation?
Core principles
Brief history of computer validation
• When and how are systems validated?
Computer Validation Process and Deliverables
• What is the SDLC (System Development Life Cycle) process?
• How does validation fit into the SDLC (Validation Life Cycle)?
• What are the expected deliverables?
• What content must be covered?
• Requirements documentation
• System/software specifications
• Design Qualification (DQ) and vendor selection
• Risk Assessment
• Validation Plans (VP)
• Installation Verification/Qualification (IQ)
• Operational Verification/Qualification (OQ)
• Performance Verification/Qualification (PQ)
• Final Reports
• Validation Summary Reports (VSR) Auditing GXP Computer Systems • Core principles
• Choosing a system to audit
• Approaches during an audit
• Primary areas of focus (what to look for)
• Additional elements of Computer Validation:
Standard Operating Procedures
Training
Validation Change Control
• Day 1 wrap-up and general questions and answers DAY TWO Overview of 21 CFR Part 11 (Part 11) • Background and purpose of Part 11
• Overview of Part 11 (review regulation)
• FAQ and general questions and answers Part 11 “Current Events” • Final FDA guidance on Part 11 scope and application (September 2003)
• Recent developments
• Industry trends and approaches Standard Approach to Part 11 Compliance • Part 11 Compliance Plan
• System Inventory
• GXP Determination and Prioritization
• Assessments (gap-analysis)
• Remediation Plans
• New systems Interactive Discussion / Question and Answer Period • Day 2 wrap-up
• Additional CSV topics (TBD during course by attendees, “Parking Lot”)
• General questions and answers
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