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DTSTAMP:20240329T071949Z
UID:bba4063a-28f0-4692-9367-1e6cddb527a9
DTSTART:20210210T100000
DTEND:20210211T100000
CLASS:PRIVATE
DESCRIPTION:Overview:
\nThe APIs covered in this guidance document inc
lude new chemical entities and APIs of biological origin and those created
by biotech processes.
\n
\nWhy should you Attend:
\nThis d
ocument was created to fulfil the need for specific guidance with regards
to GMPs for APIs. Failure to meet these requirements is a significant sour
ce of observations during regulatory inspections by FDA or global regulato
rs of manufacturers and/or of sponsors that use contract manufacturers and
the contract manufacturers themselves.
\n
\nAreas Covered in th
e Session:
\nValidation of Analytical Procedures\, C of As\, Stabilit
y Monitoring\, Expiry dating
\nValidation Policy\, Documentation\, Qu
alification\, Process validation\, Validation Approaches\, etc.
\nCha
nge Control\, Complaints and Recalls\, Rejection and Re-use of Materials\n
\nWho Will Benefit:
\nCompliance Professionals
\nQua
lity Engineer
\nQuality Engineering Manager
\nValidation Enginee
r
\nValidation Specialist
\n
\nSpeaker Profile:
\nStep
hanie Cooke is the President/CEO of Cooke Consulting\, Inc. Stephanie uses
her roughly 20 years of experience to provide global consulting services
in various areas of Regulatory Affairs\, Quality Assurance and validation
for pharmaceutical\, biological/biotech products\, medical device\, combin
ation drug/device and nutraceutical firms.
\n
\nEvent Fee: One D
ial-in One Attendee Price: US$150.00
\n
\nContact Detail:
\
nCompliance4All DBA NetZealous\,
\nPhone: +1-800-447-9407
\nEmai
l: support@compliance4All.com
SUMMARY:Practices for Active Pharmaceutical Ingredients per ICH Q7
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SUMMARY:Practices for Active Pharmaceutical Ingredients per ICH Q7
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