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2 Days Seminar 21 CFR Part 11 (Electronic Records/Electronic Signatures) Co...

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2 Days Seminar 21 CFR Part 11 (Electronic Records/Electronic Signatures) Compliance for Computer Systems Regulated by FDA

Location 11-12 March 2019 | Philadelphia

Course “ 21 CFR Part 11 (Electronic Records/Electronic Signatures) Compliance for Computer Systems Regulated by FDA “ has been Pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion.


"Each attendee will receive 2-Day workshop materials by the faculty. Seminar Also Includes Certificate, Complimentary Breakfast, Lunch & High Tea/Coffee provided by WCS"


Overview

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.


Session Highlights

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:
• Pharmaceutical
• Medical Diagnostics
• Biotechnology
• 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



Instructor Profile

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. She is currently an independent consultant, advising companies on computer system validation and large-scale IT system implementation projects.


During her career, Carolyn collaborated with FDA and other industry representatives on 21 CFR Part 11, the FDA’s electronic record/electronic signature regulation.


If you have problems registering or have registration questions: email us support@worldcomplianceseminars.com or call us Toll Free 844-267-7299 / 347-282-5400

Register today before this event fills.


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Location

Venue to be announced shortly

Philadelphia

Philadelphia, 19019

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Refund Policy

Refunds up to 30 days before event

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