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DTSTAMP:20240329T095211Z
UID:ffa07d5b-7b0b-4bd1-9854-d43a89747485
DTSTART:20210121T100000
DTEND:20210122T100000
CLASS:PRIVATE
DESCRIPTION:
\nOverview:
\nHow it may be integrated with the reco
mmendations of the guidance documents on CMC requirements.
\n
\n
Areas Covered in the Session:
\nDiscussion of the elements found in t
he guidance document for Phase 1 material
\nWhat to do at really earl
y stages
\nWhat about special IND studies?
\nWhat about preclini
cal studies?
\n
\nWho Will Benefit:
\nRegulatory Affairs pe
rsonnel who coordinate activities for the CMC sections of submissions
\nQA/QC personnel who need to plan work on early stage material
\nR
&\; D personnel who will contribute data to CMC sections
\nProject
managers for product development studies
\nQuality systems auditors<
br />\nConsultants
\n
\nSpeaker Profile:
\nSteven S. Kuwaha
ra \, Ph.D. is the founder and Principal of GXP BioTechnology LLC\, a cons
ulting firm that works in the areas covered by the GLP and GMP of drugs\,
biologics\, and nutraceuticals. Steve has over 30 years of experience in s
upervising quality control laboratories\, including an animal testing faci
lity\, and in performing GLP and GMP audits of internal and external testi
ng laboratories .
\n
\nContact Detail:
\nCompliance4All DBA
NetZealous\,
\nPhone: +1-800-447-9407
\nEmail: support@complian
ce4All.com
SUMMARY:Products Used in Early Phase IND Studies
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SUMMARY:Products Used in Early Phase IND Studies
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