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DTSTAMP:20240328T160721Z
UID:c7af5404-4ea7-4d62-9b31-ee9b4c87774b
DTSTART:20210607T100000
DTEND:20210608T100000
CLASS:PRIVATE
DESCRIPTION:Overview:
\nBiologics\, as well as small molecule pharmace
utical products\, require expiry dating.The complex structure of large mol
ecules presents greater opportunities for degradation. Biologics may lose
identity by cleavage ultimately resulting in loss of potency.
\n
\nWhy should you Attend:
\nTo collect data that supports expiry dati
ng\, the drug substance and the drug product must be thoroughly tested in
stability indicating methods. Understanding the importance of these method
s and the analysis and interpretation of the data is necessary for personn
el involved in product development\, product testing\, and product release
.
\n
\nAreas Covered in the Session:
\nTesting CQAs
\n
Stability Indicating Methods
\nTest conditions\, including stress con
ditions
\nData requirements
\nConsiderations for expiry dating\n
\nWho Will Benefit:
\nLaboratory Scientists
\nLabora
tory Managers
\nQuality Assurance Specialists
\nQuality Control
Specialists
\n
\nSpeaker Profile:
\nGwen Wise-Blackman\, Ph
.D. has over 20 years of combined experience in Cell-Based Assays and Qual
ity Systems. She has worked at DuPont Pharmaceuticals\, Catalent Pharma So
lutions (formerly Magellan Laboratories and Cardinal Health)\, and Salix P
harmaceuticals where she successfully managed multiple projects and held p
ositions of increasing accountability for scientific and quality expertise
. \;
\n
\nEvent Fee: One Dial-in One Attendee Price: $150.00
\n
\nContact Detail:
\nCompliance4All DBA NetZealous\,
\nPhone: +1-800-447-9407
\nEmail: compliance4all14@gmail.com
SUMMARY:Implementing a Compliant Stability Program for Biologics
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SUMMARY:Implementing a Compliant Stability Program for Biologics
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