BEGIN:VCALENDAR VERSION:2.0 PRODID:icalendar-ruby CALSCALE:GREGORIAN BEGIN:VEVENT DTSTAMP:20240329T101500Z UID:c5a98fea-aea6-4573-9e0d-ff432753e3ce DTSTART:20210311T073000 DTEND:20210312T073000 CLASS:PRIVATE DESCRIPTION:
Overview
\n\nThe FDA governs the comp
uter systems used to collect\, analyze\, transfer and report data that is
in support of human clinical trials required for drug approval. FDA oversi
ght is based on a Predicate Rule\, known as &ldquo\;Good Clinical Practice
s\,&rdquo\; or simply\, &ldquo\;GCPs.&rdquo\;
\nComputer systems subj
ect to GCP requirements must be thoroughly and appropriately validated in
accordance with FDA&rsquo\;s guidance on computer system validation. This
involves a rigorous set of phases and steps to ensure that\, in the langua
ge of FDA\, &ldquo\;a system does what it purports to do.&rdquo\;
\nT
he cost of adequately validating a clinical trial computer system can be h
igh\, and must be weighed against system risk and usage. GAMP 5 system cla
ssification guidelines can help ensure that a clinical trial system is cat
egorized appropriately\, based on the type of system and technology involv
ed. Along with risk\, system classification can provide a clear-cut pathwa
y for validating a system\, based on the appropriate level of testing and
validation effort.
\nIn this two day workshop conference you will lea
rn about FDA&rsquo\;s expectations for classifying\, assessing the risk\,
testing\, and validating a computer system used in clinical trial work. Yo
u will learn in detail about the System Development Life Cycle (SDLC) meth
odology used to approach Computer System Validation (CSV)\, including all
of the phases\, sequencing of events\, deliverables\, and documentation re
quirements.
\nAll types of clinical trial systems will be discussed\,
including in-house developed code\, configurable systems and custom desig
ned systems. Best industry practices and potential pitfalls in validating
clinical trial systems\, along with examples\, will be covered in detail.<
br />\nOngoing maintenance of the system in a validated state will be disc
ussed\, as well as governance\, archival and retirement.
\nWe will al
so discuss the importance of applying good project management\, business p
rocess re-engineering and organizational change management principles thro
ugh the validation process and beyond.
Why shoul d you attend
\n\nThe attendee will learn how to comply with
FDA'\;s 21 CFR Part 11 guidance\, which addresses the use of electroni
c records and electronic signatures (ER/ES). There are specific security a
nd authentication requirements that are not necessarily covered by the sta
ndard computer system validation (CSV) approach\, and go somewhat beyond t
his.
\nWe will also address the roles of people involved in validatin
g 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
\n \nUpon completing this course participants should:
\n&bull\; Under
stand FDA requirements for clinical trial Computer System Validation (CSV)
\n&bull\; Understand the System Development Life Cycle (SDLC) approa
ch to validation
\n&bull\; Utilize GAMP 5 system classification and r
isk methodologies for categorizing systems and developing a validation pat
hway
\n&bull\; Understand how to build a complete validation strategy
and program for clinical trial systems
\n&bull\; Know how to manage
the validation process and create FDA-compliant documentation
\n&bull
\; Know how to monitor a clinical trial system that is in production\, gov
erning the data and system through retirement
\n&bull\; Understand th
e roles and responsibilities required to validate a clinical trial system<
br />\n&bull\; Know how to measure cost vs. compliance risk for a clinical
trial system
\n&bull\; Understand good project management principles
\, incorporating business process re-engineering and organizational change
management into the process
\n&bull\; Know the policies and procedur
es that must be developed and maintained to support the clinical trial sys
tem in operation
\n&bull\; Understand how to leverage the vendor and
other external resources to apply the best industry practices and avoid po
tential pitfalls when validating a clinical trial system
\n&bull\; Kn
ow about FDA trends in oversight and audit of clinical trial systems and h
ow to keep abreast of these
\n \;
Who will bene fit
\n\nProfessionals in the following industries may also
benefit from the content:
\n&bull\; Pharmaceutical
\n&bull\; Med
ical Diagnostics
\n&bull\; Biotechnology
\n&bull\; Tobacco and R
elated (Vapor\, e-Cigarette\, Cigar\, etc.)
\n&bull\; Animal Health\nAny other FDA-regulated industry\, plus any Life Science Consulting
or Contracting firm
\n&bull\; Information technology managers and ana
lysts
\n&bull\; Production managers and analysts
\n&bull\; QC/QA
managers and analysts
\n&bull\; Clinical data managers and scientist
s
\n&bull\; Compliance managers
\n&bull\; Lab managers and staff
\n&bull\; Automation analysts
\n&bull\; Computer system validat
ion specialists
\n&bull\; GMP training specialists
\n&bull\; Bus
iness stakeholders and individuals who are responsible for computer system
validation planning\, execution\, reporting\, compliance\, training and a
udit
\n&bull\; Consultants working in the life sciences\, tobacco and
related industries who are involved in computer system implementation\, v
alidation and compliance