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VERSION:2.0
PRODID:icalendar-ruby
CALSCALE:GREGORIAN
BEGIN:VEVENT
DTSTAMP:20240329T052358Z
UID:534835eb-29b3-4b2a-800a-11360535d378
DTSTART:20210524T130000
DTEND:20210525T130000
CLASS:PRIVATE
DESCRIPTION:Design controls involve the translation of user requirements (a
ka Voice of the Customer) into specific technical requirements as design i
nputs. These design inputs then form the basis of the design specification
\, which becomes the design output. Since design controls requires tracing
backwards and forwards in order to link the requirements to their satisfa
ction\, a problem faced by many companies is in having to maintain duplica
te information across many controlled documents. This repetition is a majo
r source of inconsistencies and errors.
\n \;\n
Areas C overed
\n\n \;
\n\n&bull\; \;  \;  \;
 \;Brief introduction to Lean Documents and Lean Configuration
\
n&bull\; \;  \;  \;  \;Quality System Regulation\, 21 CFR
Part 820\, and ISO 13485 as these apply to design control documents
\
n&bull\; \;  \;  \;  \;Traceability Matrix
\n&bull\;&
nbsp\;  \;  \;  \;Applying lean document and lean configuratio
n principles to the above
\n&bull\; \;  \;  \;  \;Bri
nging it all togethe
 \;
\n\nWho will Benefit< /strong>
\n\n \;
\n\nManagers\, Supervisors\, Directors\, and Vice-Presidents in the areas of:
\n\n&bull\; \;  \; &nbs
p\;  \;R&\;D
\n&bull\; \;  \;  \;  \;Manufactu
ring Engineering
\n&bull\; \;  \;  \;  \;Design Assur
ance
\n&bull\; \;  \;  \;  \;Quality Assurance
\
n&bull\; \;  \;  \;  \;Operations
\n&bull\; \; &n
bsp\;  \;  \;Document Control