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DTSTART:19700308T020000
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UID:2140535:Event:81097
DTSTAMP:20260523T143427Z
SUMMARY:Applied Statistics for FDA Process Validation 2019
DESCRIPTION:In Guidance for Industry Process Validation: General Prin
 ciple and Practices, process validation is defined as, \"\"...the col
 lection and evaluation of data, from the process design stage through 
 commercial production..\" The guidance further delineates the 'process
  design stage through commercial production' into three distinct stage
 s of the product lifecycle:\nStage 1: Process Design: The commercial m
 anufacturing process is defined during this stage based on knowledge g
 ained through development and scale-up activities.\nStage 2: Process Q
 ualification: During this stage, the process design is evaluated to de
 termine if the process is capable of reproducible commercial manufactu
 ring.\nStage 3: Continued Process Verification: Ongoing assurance is g
 ained during routine production that the process remains in a state of
  control.\nThe first stage of process validation is process design. Th
 e Process Validation guidance document states, \"A successful validati
 on program depends on information and knowledge from product and proce
 ss development. This knowledge and understanding is the basis for esta
 blishing an approach to control of a manufacturing process that result
 s in products with desired quality attributes:\nManufactures should:\n
 \nUnderstand the sources of variation\nDetect the presence and degree 
 of variation\nUnderstand the impact of variation on the process and ul
 timately on product attributes\nControl the variation in a manner comm
 ensurate with the risk it represents to the process and product.\"\n\n
 The second stage of process validation is process qualification. Altho
 ugh stage 2 has two elements, this course will focus on recommendation
 s for the second element, PPQ. PPQ \"combines the actual facility, uti
 lities, equipment (each now qualified), and the trained personnel with
  the commercial manufacturing process, control procedures, and compone
 nts to produce commercial batches.\" Additionally, the process validat
 ion guidance document that \"Each manufacturer should judge whether it
  has gained sufficient understanding to provide a high degree of assur
 ance in its manufacturing process to justify commercial distribution o
 f the product. Focusing exclusively on qualification efforts without u
 nderstanding the manufacturing process and associated variations may n
 ot lead to adequate assurance of quality.\"\n\nFor more information vi
 sit https://medtechiq.ning.com/events/applied-statistics-for-fda-proce
 ss-validation-2019
DTSTART;TZID=America/New_York:20190115T090000
DTEND;TZID=America/New_York:20190116T180000
CATEGORIES:seminar
LOCATION:DoubleTree by Hilton Philadelphia Airport
WEBSITE:https://www.globalcompliancepanel.com/seminar/applied-statisti
 cs-for-FDA-process-validation-901927SEMINAR?medtechiq-JAN-SEO-2019
URL:https://www.globalcompliancepanel.com/seminar/applied-statistics-f
 or-FDA-process-validation-901927SEMINAR?medtechiq-JAN-SEO-2019
CONTACT:18004479407
ORGANIZER;CN="John Robinson":https://medtechiq.ning.com/profile/JohnRo
 binson
ATTACH;FMTTYPE="image/jpeg":https://storage.ning.com/topology/rest/1.0
 /file/get/162317838?profile=original
ATTENDEE;ROLE=REQ-PARTICIPANT;PARTSTAT=ACCEPTED;RSVP=TRUE;CN="John Rob
 inson":https://medtechiq.ning.com/profile/JohnRobinson
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