BEGIN:VCALENDAR VERSION:2.0 PRODID:icalendar-ruby CALSCALE:GREGORIAN BEGIN:VEVENT DTSTAMP:20240328T172550Z UID:ebb2219e-4ca1-4702-b93f-e18ab2bb1919 DTSTART:20210309T130000 DTEND:20210310T130000 CLASS:PRIVATE DESCRIPTION:
FDA requires that all
computer systems used to produce\, manage and report on &ldquo\;GxP&rdquo\
; (GMP\, GLC\, GCP) related products be validated and maintained in accord
ance with specific rules. This webinar will help you understand the FDA&rs
quo\;s current thinking on computer systems that are validated and subject
to inspection and audit.
\nAs a &ldquo\;GxP&rdquo\; system\, followi
ng Good Manufacturing\, Laboratory and Clinical Practices\, the computer s
ystem must be validated in accordance with FDA requirements. If electronic
records and/or electronic signatures (ER/ES) are incorporated into the sy
stem\, FDA&rsquo\;s CFR Part 11 guidance on ER/ES must be followed.
\nThis webinar 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.
 \;
\n\nFDA requires that all computer systems that h
andle data regulated by the Agency to be validated in accordance with thei
r guidance on computerized systems. This guidance was first issued in 1983
\, and the main points of focus remain consistent today\, despite the numb
er of years that have passed and the technology changes that have taken pl
ace.
\nThe guidance was revisited for its application to the medical
device industry\, as the first issuance addressed pharmaceuticals. In 1997
\, 21 CFR Part 11 was issued to address electronic records and signatures\
, as many laboratories and other FDA-regulated organizations began seeking
ways to move into a paperless environment. This guidance has been modifie
d over the years to make it more palatable to industry\, and this includes
discretionary enforcement measures. The intent was to avoid creating a hu
ge regulatory compliance cost to industry that was initially preventing co
mpanies from embracing the technology.
\nThis session will provide so
me insight into current trends in compliance and enforcement. Some are bas
ed on technology changes\, and these will continue to have an impact as ne
w innovations come into use in the industry.
 \;
\n\n&bull\; Learn about
Computer System Validation (CSV) and the System Development Life Cycle (S
DLC) Methodology
\n&bull\; Understand &ldquo\;GxP&rdquo\; Systems
\n&bull\; Understand 21 CFR Part 11\, Electronic Records/Electronic Sign
atures (ER/ES)
\n&bull\; Learn how Data Archival plays a key role in
ensuring security\, integrity and compliance
\n&bull\; Learn how to d
evelop a solid Validation Strategy that will take into account the system
risk assessment and system categorization (GAMP V) processes
\n&bull\
; Learn about recent FDA findings for companies in regulated industries
\n&bull\; Learn about recent trends in technology that need to be addre
ssed in the CSV approach \;
\n&bull\; Q&\;A
 \;
\n\nProfession
als in the following industries may also benefit from the content:
\n
&bull\; Pharmaceutical
\n&bull\; Medical Device
\n&bull\; Biotec
hnology
\n&bull\; Tobacco and Related (Vapor\, e-Cigarette\, Cigar\,
etc.)
\nAny other FDA-regulated industry\, plus any Life Science Cons
ulting or Contracting firm
\n&bull\; Information technology managers
and analysts
\n&bull\; QC/QA managers and analysts
\n&bull\; Cli
nical data managers and scientists
\n&bull\; Compliance managers
\n&bull\; Lab managers and staff
\n&bull\; Automation analysts
\n&bull\; Computer system validation specialists
\n&bull\; GMP traini
ng specialists
\n&bull\; Business stakeholders and individuals who ar
e responsible for computer system validation planning\, execution\, report
ing\, compliance\, and audit
\n&bull\; Consultants working in the lif
e sciences\, tobacco and related industries who are involved in computer s
ystem implementation\, validation and compliance
\n&bull\; Anyone inv
olved in the planning\, execution\, and reporting of a clinical trial (spo
nsor\, director\, researcher\, regulatory role\, etc.)