BEGIN:VCALENDAR VERSION:2.0 PRODID:icalendar-ruby CALSCALE:GREGORIAN BEGIN:VEVENT DTSTAMP:20240329T155643Z UID:69568ece-3c40-4906-92e0-0edacef031ed DTSTART:20210301T083000 DTEND:20210302T083000 CLASS:PRIVATE DESCRIPTION:
Overview
\n\nFDA requires that all co
mputer systems used to produce\, manage and report on &ldquo\;GxP&rdquo\;
(GMP\, GLC\, GCP) related products be validated and maintained in accordan
ce with specific rules. This training will help you understand the FDA&rsq
uo\;s current thinking on computer systems that are validated and subject
to inspection and audit.
\nAs a &ldquo\;GxP&rdquo\; system\, followin
g Good Manufacturing\, Laboratory and Clinical Practices\, the computer sy
stem must be validated in accordance with FDA requirements. If electronic
records and/or electronic signatures (ER/ES) are incorporated into the sys
tem\, FDA&rsquo\;s CFR Part 11 guidance on ER/ES must be followed.
\nThis workshop will focus on the key areas that are most importa
nt\, including security and data integrity. Implementing and following the
System Development Life Cycle (SDLC) methodology is the best approach for
computer system validation and maintaining data integrity. The life cycle
approach takes all aspects of validation into account throughout the life
of the system and the data that it houses. The data is a key asset for an
y FDA-regulated company and must be protected through its entire retention
period.
Why should you attend
\n\n< p>FDA requires that all computer systems that handle data regulated by the Agency to be validated in accordance with their guidance on computerized systems. This guidance was first issued in 1983\, and the main points of f ocus remain consistent today\, despite the number of years that have passe d and the technology changes that have taken place. \;
\n\nSession High lights
\n\n&bull\; Learn about Computer System Validation (
CSV) and the System Development Life Cycle (SDLC) Methodology
\n&bull
\; Understand &ldquo\;GxP&rdquo\; Systems
\n&bull\; Understand 21 CFR
Part 11\, Electronic Records/Electronic Signatures (ER/ES)
\n&bull\;
Learn how Data Archival plays a key role in ensuring security\, integrity
and compliance
\n&bull\; Learn how to develop a solid Validation Str
ategy that will take into account the system risk assessment and system ca
tegorization (GAMP V) processes
\n&bull\; Learn about recent FDA find
ings for companies in regulated industries
\n&bull\; Learn about rece
nt trends in technology that need to be addressed in the CSV approach
&bull\; Q&\;A
\n\nWho will benefit
\n\nProfessionals in the following industries may also benefit from
the content:
\n&bull\; Pharmaceutical
\n&bull\; Medical Device<
br />\n&bull\; Biotechnology
\n&bull\; Tobacco and Related (Vapor\, e
-Cigarette\, Cigar\, etc.)
\nAny other FDA-regulated industry\, plus
any Life Science Consulting or Contracting firm
\n&bull\; Information
technology managers and analysts
\n&bull\; QC/QA managers and analys
ts
\n&bull\; Clinical data managers and scientists
\n&bull\; Com
pliance managers
\n&bull\; Lab managers and staff
\n&bull\; Auto
mation analysts
\n&bull\; Computer system validation specialists
\n&bull\; GMP training specialists
\n&bull\; Business stakeholders a
nd individuals who are responsible for computer system validation planning
\, execution\, reporting\, compliance\, and audit
\n&bull\; Consultan
ts working in the life sciences\, tobacco and related industries who are i
nvolved in computer system implementation\, validation and compliance
\n&bull\; Anyone involved in the planning\, execution\, and reporting of
a clinical trial (sponsor\, director\, researcher\, regulatory role\, etc.
)