BEGIN:VCALENDAR VERSION:2.0 PRODID:icalendar-ruby CALSCALE:GREGORIAN BEGIN:VEVENT DTSTAMP:20240329T015601Z UID:973fe2f4-20fc-44cb-819d-356305dbdd25 DTSTART:20210226T130000 DTEND:20210227T130000 CLASS:PRIVATE DESCRIPTION:
This webinar will focu
s on medical devices\, IEC 62304\, and what is required for compliance.
\nMedical devices can use very complex software applications\, and any
failure to function properly could lead to potential injury or death of a
consumer or patient.
\nThere is a need to improve overall standards f
or medical device software to account for this high risk potential.
\
nThe majority of software recalls in the 1990s were due to software defect
s that were a result of software being upgraded.
\nThere is a need to
restructure medical device software development processes\, and adopting
IEC 62304 provides a standard for design that is accepted in the United St
ates (US) and European Union (EU).
\nIEC 62304 is a risk-based approa
ch to compliance that ensures the standards followed are appropriate for t
heir potential assessed risk.
\nIEC 62304 is a lifecycle approach tha
t defines the activities and tasks required to ensure software for medical
devices will be safe and reliable.
\nApplying IEC 62304 will reduce
your overall rate of software failure and improve your bottom line.
 \;
\n\nThis webinar is intended for those working in the FDA-regulated ind
ustries\, including pharmaceutical\, medical device\, biological\, animal
health and tobacco. Functions that are applicable include research and dev
elopment\, manufacturing\, Quality Control\, distribution\, clinical testi
ng and management\, adverse events management and post-marketing surveilla
nce.
\nYou should attend this webinar if you are responsible for plan
ning\, executing or managing the implementation of any system governed by
FDA regulations\, or if you are maintaining or supporting such a system.
p>\n\n
 \;
\n\n&bull\; Providing safe and effective medical devices is in the be
st interests of all those involved in developing software for these produc
ts\, and for those involved in developing medical devices that use softwar
e. \;
\n&bull\; This session will provide insight into the IEC 62
304 standard as it is applied to medical device software.
\n&bull\; Y
ou will learn how to apply this standard to your own work processes.
\n&bull\; You will also gain insight into the current industry best practi
ces that will help you with IEC 62304 compliance.
\n&bull\; Q&\;A<
/p>\n\n
 \;
\n\nProfessionals in the following industries may also benefit from th
e content:
\n&bull\; Pharmaceutical
\n&bull\; Medical Device
\n&bull\; Biotechnology
\n&bull\; Tobacco and Related (Vapor\, e-Ci
garette\, Cigar\, etc.)
\nAny other FDA-regulated industry\, plus any
Life Science Consulting or Contracting firm
\n
\n&bull\; Inform
ation technology managers and analysts
\n&bull\; QC/QA managers and a
nalysts
\n&bull\; Clinical 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 training specialists
\n&bull\; Business stakehold
ers and individuals who are responsible for computer system validation pla
nning\, execution\, reporting\, compliance\, and audit
\n&bull\; Cons
ultants working in the life sciences\, tobacco and related industries who
are involved in computer system implementation\, validation and compliance
\n&bull\; Anyone involved in the planning\, execution\, and reportin
g of a clinical trial (sponsor\, director\, researcher\, regulatory role\,
etc.)