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21 CFR Part 11 (Electronic Records/Electronic Signatures) Compliance for Computer Systems Regulated by FDA
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The FDA governs the computer systems used to collect, analyze, transfer and report data that is in support of human clinical trials required for drug approval. FDA oversight is based on a Predicate Rule, known as “Good Clinical Practices,” or simply, “GCPs.”
Computer systems subject to GCP requirements must be thoroughly and appropriately validated in accordance with FDA’s guidance on computer system validation. This involves a rigorous set of phases and steps to ensure that, in the language of FDA, “a system does what it purports to do.”
The cost of adequately validating a clinical trial computer system can be high, and must be weighed against system risk and usage. GAMP 5 system classification guidelines can help ensure that a clinical trial system is categorized appropriately, based on the type of system and technology involved. Along with risk, system classification can provide a clear-cut pathway for validating a system, based on the appropriate level of testing and validation effort.
In this two day workshop conference you will learn about FDA’s expectations for classifying, assessing the risk, testing, and validating a computer system used in clinical trial work. You will learn in detail about the System Development Life Cycle (SDLC) methodology used to approach Computer System Validation (CSV), including all of the phases, sequencing of events, deliverables, and documentation requirements.
All types of clinical trial systems will be discussed, including in-house developed code, configurable systems and custom designed systems. Best industry practices and potential pitfalls in validating clinical trial systems, along with examples, will be covered in detail.
Ongoing maintenance of the system in a validated state will be discussed, as well as governance, archival and retirement.
We will also discuss the importance of applying good project management, business process re-engineering and organizational change management principles through the validation process and beyond.
Why should you attend
The attendee will learn how to comply with FDA's 21 CFR Part 11 guidance, which addresses the use of electronic records and electronic signatures (ER/ES). There are specific security and authentication requirements that are not necessarily covered by the standard computer system validation (CSV) approach, and go somewhat beyond this.
We will also address the roles of people involved in validating and supporting the systems, aside from just the standard system users. There are many tasks and functions they need to understand in order to be in compliance.
Upon completing this course participants should:
• Understand FDA requirements for clinical trial Computer System Validation (CSV)
• Understand the System Development Life Cycle (SDLC) approach to validation
• Utilize GAMP 5 system classification and risk methodologies for categorizing systems and developing a validation pathway
• Understand how to build a complete validation strategy and program for clinical trial systems
• Know how to manage the validation process and create FDA-compliant documentation
• Know how to monitor a clinical trial system that is in production, governing the data and system through retirement
• Understand the roles and responsibilities required to validate a clinical trial system
• Know how to measure cost vs. compliance risk for a clinical trial system
• Understand good project management principles, incorporating business process re-engineering and organizational change management into the process
• Know the policies and procedures that must be developed and maintained to support the clinical trial system in operation
• Understand how to leverage the vendor and other external resources to apply the best industry practices and avoid potential pitfalls when validating a clinical trial system
• Know about FDA trends in oversight and audit of clinical trial systems and how to keep abreast of these
Who will benefit
Professionals in the following industries may also benefit from the content:
• Medical Diagnostics
• Tobacco and Related (Vapor, e-Cigarette, Cigar, etc.)
• Animal Health
Any other FDA-regulated industry, plus any Life Science Consulting or Contracting firm
• Information technology managers and analysts
• Production managers and analysts
• QC/QA managers and analysts
• Clinical data managers and scientists
• Compliance managers
• Lab managers and staff
• Automation analysts
• Computer system validation specialists
• GMP training specialists
• Business stakeholders and individuals who are responsible for computer system validation planning, execution, reporting, compliance, training and audit
• Consultants working in the life sciences, tobacco and related industries who are involved in computer system implementation, validation and compliance
Session I Introduction to FDA (4-49)
Session II 21 CFR Part 11/Annex 11 Compliance for Electronic Records and Electronic Signatures (50-114)
Session III The Five Keys to COTS Computer System Validation (115-139)
Session IV The Validation Team (140-151)
Session V Preparing for an FDA Audit (152-168)
Session VI COTS Risk-Based Computer System Validation Risk Assessment, Traceability Matrix (169-175)
Session VII How to Write Requirements and Specifications (176-188)
Session VIII How to Conduct a Hazard Analysis/ Risk Assessment – Exercise (189-199)
Session IX Software Testing (200-208)
Session X System Change Control (209-214)
Session XI Purchasing COTS Software (215-268)
Session XII Cost Reduction Without Increasing Regulatory or Business Risk (269-362)
Carolyn Troiano has more than 35 years of experience in computer system validation in the pharmaceutical, medical device, animal health, tobacco and other FDA-regulated industries.
(Contact us : 844-267-7299 | 954-947-5671
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