BEGIN:VCALENDAR VERSION:2.0 PRODID:icalendar-ruby CALSCALE:GREGORIAN BEGIN:VEVENT DTSTAMP:20240329T094818Z UID:43186d49-5b3f-4a6f-93a6-683e25d387f9 DTSTART:20210222T083000 DTEND:20210223T083000 CLASS:PRIVATE DESCRIPTION:
Course &ldquo\;Analytical Methods Validation for FDA Compliance \;&ldquo\; has been Pre-approved by RAPS as eligible for up to 12 credits towards a participant'\;s RAC recertification upon full completion.
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\n\n"\; Each attendee will receive 2-Day workshop materials by the faculty. Semina r Also Includes Certificate\, Complimentary Breakfast\, Lunch &\; High Tea/Coffee provided by WCS"\;
\n\nWhy have Thousands of companie s received warning letters for laboratory control and out-of-specification violations? \;Improper analytical method validation testing
\n\nThousands of analytical tests are at its heart -- sometimes Hundreds of t housands -- that must be validated and/or verified according to strict FDA protocols and international regulatory agency expectations.
\n\nAnd a warning letter isn'\;t the only consequence of a poor validation sys tem. False passes\, poor reducibility\, late shipments and production disr uptions are all risks you face without a proper validation process in plac e.
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\n\nSession H ighlights
\n\nTopic 1: Regulatory Requirements/Guid ance on Analytical Method
\n\nValidation
\n&bull\; Ter
minology defined: qualification\, validation\, revalidation and verificati
on
\n&bull\; FDA\, EMA\, ICH requirements and guidance
\n&bull\;
Validation lifecycle for analytical methods
Topic 2: An alytical Method Pre-Validation &ndash\; Stage 1
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\
n&bull\; Analytical Target Profile (ATP)
\n&bull\; ICH Q8\, Q9 and Q1
0 adherence - Pre-Validation Requirements
\n&bull\; QC instrumentatio
n qualification
\n&bull\; Training
\n&bull\; Critical assay reag
ent qualification
Topic 3: Analytical Method Validation Characteristics &ndash\; Stage 2
\n\n&bull\; Specificity\,
accuracy\, precision\, linearity\, range
\n&bull\; LOD and LOQ
\
n&bull\; Robustness and stability-indicating
\n&bull\; Value of syste
m suitability controls
\nTopic 4: Test Method Validation Protocol
\n&bull\; Elements of a validation protocol
\n&bull\; Pre-planning
and planning steps
\n&bull\; Identification and documentation of assa
y characteristics
\nneeding to be validated
\n&bull\; Critical i
mportance of assigning pre-defined acceptance criteria
T opic 4: Test Method Validation Protocol
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\n&bull\;
Elements of a validation protocol
\n&bull\; Pre-planning and plannin
g steps
\n&bull\; Identification and documentation of assay character
istics
\nneeding to be validated
\n&bull\; Critical importance o
f assigning pre-defined acceptance criteria
Topic 5: Tes t Method Validation Report
\n\n&bull\; Elements of the vali
dation report
\n&bull\; Elements of the validation protocol and the a
ssociated final validation report
\n&bull\; Meeting the pre-defined a
cceptance criteria
\n&bull\; Handling deviations/OOS&rsquo\;s\, when
(not if) they happen
Topic 6: Regulatory Concerns About Test Method Validations
\n\n&bull\; Validation issues ident
ified during the review of the submitted
\nmarket dossier
\n&bul
l\; Validation issues identified during regulatory inspections
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l\; Test method validation &ldquo\;continuous improvement&rdquo\; &ndash\;
ICH Q10
 \;
\n\nWho will benefit
\n\n&bull\; Analytical Development
\n&bull\; Quality Assur
ance
\n&bull\; Quality Control
\nValidation \;
\n&bull\
; Regulatory Affairs
\n&bull\; R&\;D \;
\n&bull\; Technic
al Operations
All Regulatory affairs personnel responsible for t he review of such data will also benefit from this course.
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