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DTSTART:19700308T020000
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UID:2140535:Event:77518
DTSTAMP:20260523T175707Z
SUMMARY:Products Used in Early Phase IND Studies
DESCRIPTION:Overview:How it may be integrated with the recommendations
  of the guidance documents on CMC requirements.\nAreas Covered in the 
 Session:Discussion of the elements found in the guidance document for 
 Phase 1 materialWhat to do at really early stagesWhat about special IN
 D studies?What about preclinical studies?\nWho Will Benefit:Regulatory
  Affairs personnel who coordinate activities for the CMC sections of s
 ubmissionsQA/QC personnel who need to plan work on early stage materia
 lR & D personnel who will contribute data to CMC sectionsProject manag
 ers for product development studiesQuality systems auditorsConsultants
 \nSpeaker Profile:Steven S. Kuwahara , Ph.D. is the founder and Princi
 pal of GXP BioTechnology LLC, a consulting firm that works in the area
 s covered by the GLP and GMP of drugs, biologics, and nutraceuticals. 
 Steve has over 30 years of experience in supervising quality control l
 aboratories, including an animal testing facility, and in performing G
 LP and GMP audits of internal and external testing laboratories .\nEve
 nt Fee: One Dial-in One Attendee Price: US$150.00\nContact Detail:Comp
 liance4All DBA NetZealous,Phone: +1-800-447-9407Email: support@complia
 nce4All.com\n\nFor more information visit https://medtechiq.ning.com/e
 vents/products-used-in-early-phase-ind-studies
DTSTART;TZID=America/New_York:20180119T100000
DTEND;TZID=America/New_York:20180119T111500
CATEGORIES:online
LOCATION:Fremont
WEBSITE:http://www.compliance4all.com/control/w_product/~product_id=50
 1658LIVE?channel=medtechiq_Jan_2018_SEO
URL:http://www.compliance4all.com/control/w_product/~product_id=501658
 LIVE?channel=medtechiq_Jan_2018_SEO
CONTACT:18004479407
ORGANIZER:Event Manager
ATTACH;FMTTYPE="image/jpeg":http://storage.ning.com/topology/rest/1.0/
 file/get/2562016229?profile=original
ATTENDEE;ROLE=REQ-PARTICIPANT;PARTSTAT=ACCEPTED;RSVP=TRUE;CN="Adam Fle
 ming":https://medtechiq.ning.com/profile/Compliance4all
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