BEGIN:VCALENDAR
VERSION:2.0
PRODID:icalendar-ruby
CALSCALE:GREGORIAN
BEGIN:VEVENT
DTSTAMP:20240328T133023Z
UID:84f4e103-1c64-4c8b-9736-141ae97c8d57
DTSTART:20210326T113000
DTEND:20210327T113000
CLASS:PRIVATE
DESCRIPTION:Overview
\nThis course provides guidance
on how to perform QC analytical test method validations and transfers. One
of the most critical factors in developing and marketing pharmaceutical d
rug substances and drug products is ensuring that the analytical methods u
sed for analysis can generate valid data upon which business and regulator
y decisions can be made. FDA\, ICH and USP have each recognized the import
ance of this relative to the drug development process and have each expand
ed method validation requirements in recent years.
\nHowever\, with o
nly limited guidance\, industry has been left to interpret how to adequate
ly comply with the regulations. \;This course provides a comprehensive
overview of the international regulatory authority requirements and expec
tations for test method validation of these assays.
\nThis course wil
l prepare attendees with the knowledge and tools to plan and execute test
method validation packages for the NDA\, BLA and MAA market application do
ssiers\, covering in-process\, release and stability assays commonly used
by QC.
\nWhether involved in method development\, method validation\,
method verification or method transfer\, this course will provide a broad
understanding and &ldquo\;hands-on&rdquo\; knowledge of the method valida
tion process and the difficulties encountered in validating methods to com
ply with today&rsquo\;s upgraded FDA CDER requirements. Lectures will incl
ude some of the more common mathematical and statistical treatments of val
idation data. Because of the tremendous effort that can be expended in con
ducting validation studies\, efficiency of experimental design and documen
tation will be stressed throughout the discussions.\n
Session Hi ghlights
\n\nTopic 1: Regulatory Requirements/Guida
nce on Analytical Method
\nValidation
\n&bull\; Termino
logy defined: qualification\, validation\, revalidation and verification\n&bull\; FDA\, EMA\, ICH requirements and guidance
\n&bull\; Val
idation lifecycle for analytical methods
Topic 2: Analyt
ical Method Pre-Validation &ndash\; Stage 1
\n&bull\; Analyt
ical Target Profile (ATP)
\n&bull\; ICH Q8\, Q9 and Q10 adherence - P
re-Validation Requirements
\n&bull\; QC instrumentation qualification
\n&bull\; Training
\n&bull\; Critical assay reagent qualificati
on
Topic 3: Analytical Method Validation Characteristics
&ndash\; Stage 2
\n&bull\; Specificity\, accuracy\, precisi
on\, linearity\, range
\n&bull\; LOD and LOQ
\n&bull\; Robustnes
s and stability-indicating
\n&bull\; Value of system suitability cont
rols
Topic 4: Test Method Validation Protocol\n&bull\; Elements of a validation protocol
\n&bull\; Pre-plannin
g and planning steps
\n&bull\; Identification and documentation of as
say characteristics needing to be validated&bull\; Critical importance of
assigning pre-defined acceptance criteria
Topic 5: Test Method Validation Report
\n\n&bull\; Elements of the valida
tion report
\n&bull\; Elements of the validation protocol and the ass
ociated final validation report
\n&bull\; Meeting the pre-defined acc
eptance criteria
\n&bull\; Handling deviations/OOS&rsquo\;s\, when (n
ot if) they happen
Topic 6: Regulatory Concerns About Te st Method Validations
\n\n&bull\;Validation issues identifi
ed during the review of the submitted market dossier
\n&bull\;Validat
ion issues identified during regulatory inspections
\n&bull\;Test met
hod validation &ldquo\;continuous improvement&rdquo\; &ndash\; ICH Q10
 \;
\n\nWho will Benefit
\n\n-Personnel from the pharmaceutical and medical device industry
\n-
Manufacturers of drug substances (APIs)
\n-Contract laboratory staff<
br />\n-Laboratory managers and staff
\n-Analysts
\n-QA managers
and personnel
\n-Regulatory affairs personnel
\n-Training depar
tment personnel
\n-Documentation department personnel
\n-Consult
ants
\n-Validation specialists