Computer Systems Validation (CSV) also known as Software Validation is all-pervasive in the Life Sciences Industry[1][2]. It is a requirement of all the predicate rules, as well as 21 CFR 11 and Annex 11. However, unless one knows how to implement CSV, it is often very hard to detect the requirement for CSV, and very hard to determine what needs to be done, to meet domestic and / or international regulations or business continuity requirements. In addition, the FDA has stepped up 21 CFR 11 inspections that include CSV.
Consequently, the number of 483s / Warning Letters due to CSV continue to be on the rise. It is estimated that 1 in 5 of Medical Device Recalls are due to incorrect CSV. Currently, there are many outstanding Official Actions by Regulatory Authorities (e.g. 483s, Warning Letters, etc.) that include citations for CSV. This is expected to further escalate as technology advances and companies need to consider Cloud Technologies, as well as patient privacy issues such as HIPAA
Costs of not understanding CSV are enormous: One 2013 incorrect implementation of CSV resulted in fines of up to $3Billion. Software Projects requiring CSV often overrun by several months. Corrections to a CSV 483 can result in costs of $250,000 and often multiple issues are found. More importantly, CSV is a foundation to other discovery, development & commercialization of products and CSV failure includes failure of those efforts.
Learning Objectives:
This Hands-On course will provide the attendees with both a strategic and a tactical understanding of how CSV fits into all aspects of the Life Sciences Industry and how to implement CSV to ensure successful inspections. It will address the following topics:
- What is 21 CFR 11 and Computer Systems Validation
- The FDA’s perspective (also, other regulatory agencies)
- How to implement 21 CFR 11 and Computer Systems Validation
- Special Topics: Excel, Cloud and Business Continuity
- Project Management for 21 CFR 11
- Quality Assurance for 21 CFR 11
CSV = Computer Systems Validation. This term will be used to described both Computer Systems Validation and Software Validation
Life Sciences industry includes all areas of Pharma, Biotech, Medical Devices, Food, Cosmetics, Companion Animals, Tobacco, Blood products etc.
Who will Benefit:
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Titles:
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- 08.30 AM - 09.00 AM: Registration
- 09.00 AM: Session Start
- Lecture 1: Introduction / Background
- Introductions / Participants’
- Understanding / Participants’ Objectives for the Course (Please come prepared to discuss)
- 21 CFR 11 & CSV – Basic Concepts Computer Validation – an FDA Perspective
- Lecture 2: CSV at a High Level
- CSV: It’s Easy!! Really!!
- CSV components and deliverables
- 21 CFR 11 Jeopardy!!!
- Lecture 3: CSV Detailed Study
- Risk Assessment
- Validation Plan
- Requirements Specifications
- Exercise on how to create requirements
- Lecture 4: CSV Detailed Study (Cont’d)
- Functional & Design Specifications
- Software Configuration and Build
- Exercise on how to create Design Specifications
- Lecture 5: CSV Detailed Study (Cont’d)
- SOPs
- Traceability Matrix
- Verification and Testing
- Exercise Creating Validation Scripts
- Validation Report
- Validation Registry
- Lecture 6: Special Topics
- CSV for Excel and other spreadsheets
- Regulatory Compliance for the Cloud
- Implementing Business Continuity for CSV
- Lecture 7: Project Management for CSV
- Project Management for CSV
- Selecting software for 21 CFR 11 Compliance
- Lecture 8: Quality Assurance for CSV
- How to audit CSV projects
- Computer Validation – an FDA Perspective
- 483s and Warning Letters
Angela Bazigos
CEO, Touchstone Technologies Silicon Valley
Angela Bazigos, is the CEO of Touchstone Technologies Silicon Valley, Inc. "Knowledge is Power". She has 35 years of experience in the Lifesciences industry spanning GLP, GCP, GMP, Medical Devices & 21 CFR 11 and has a patent aimed at speeding up Software Compliance.
Ms. Bazigos is a Past President of PRCSQA, a member of the SQA CVIC, ASQ, DIA and RAPS. She works closely with the FDA on behalf of her clients. She consults to LifeScience Investment Groups as well as to Pharma / Biotech / Medical Device companies on compliance matters, including strategy, submissions, quality assurance and remediations following action by the FDA.
More recently, Ms. Bazigos co-authored Computerized Systems in Clinical Research / Current Data Quality and Data Integrity Concepts with FDA, DIA and Academia. She was on the board for UC Berkeley’s Business School for Executive Education in Life Sciences and is now on the Stanford Who’s Who Registry for contributions to the Lifesciences industry.
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