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VERSION:2.0
PRODID:icalendar-ruby
CALSCALE:GREGORIAN
BEGIN:VEVENT
DTSTAMP:20240328T125850Z
UID:bcd51615-84f1-4895-aef3-50e827918b6a
DTSTART:20211109T120000
DTEND:20211110T120000
CLASS:PRIVATE
DESCRIPTION:Overview:  \;
\nThe US FDA expects that as part of a p
roduct development Design Control
\nProgram risk management will be c
onducted. FDA recommends using ISO
\n14971 as a guide and has accepte
d it as a recognized standard.
\n
\nWhy should you Attend: \
;
\nFDA expects that as part of a product development program risk ma
nagement
\nwill be conducted. FDA recommends using ISO 14971 as a gui
de and has
\naccepted it as a recognized standard. \;
\n
\nAreas Covered in the Session:
\nExplanation of Hazard Analysis te
rms
\nHazard Analysis Process Explanation using a Template
\nExa
mples of Terms will be given
\nHazard Analysis Examples will be Cover
ed Step by Step
\n
\nWho Will Benefit:
\nEngineer
\nEn
gineering Manager
\nRegulatory Personnel
\nQA
\n
\nSpe
aker Profile:
\nEdwin Waldbusser is a consultant retired from industr
y after 20 years in
\nmanagement of development of medical devices (5
patents). He has been
\nconsulting in the US and internationally in
the areas of design control\, risk
\nanalysis and software validation
for the past 8 years. Mr. Waldbusser has a
\nBS in Mechanical Engine
ering and an MBA.
\n
\nContact Detail:
\nCompliance4All DBA
NetZealous\,
\nPhone: +1-800-447-9407
\nEmail: support@complian
ce4All.com
SUMMARY:Medical Device Hazard Analysis Following ISO 14971 - 2020
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SUMMARY:Medical Device Hazard Analysis Following ISO 14971 - 2020
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