BEGIN:VCALENDAR
PRODID:NingEventWidget-v1
VERSION:2.0
METHOD:PUBLISH
BEGIN:VTIMEZONE
TZID:America/New_York
X-LIC-LOCATION:America/New_York
BEGIN:DAYLIGHT
TZOFFSETFROM:-0500
TZOFFSETTO:-0400
TZNAME:EDT
DTSTART:19700308T020000
RRULE:FREQ=YEARLY;BYMONTH=3;BYDAY=2SU
END:DAYLIGHT
BEGIN:STANDARD
TZOFFSETFROM:-0400
TZOFFSETTO:-0500
TZNAME:EST
DTSTART:19701101T020000
RRULE:FREQ=YEARLY;BYMONTH=11;BYDAY=1SU
END:STANDARD
END:VTIMEZONE
BEGIN:VEVENT
UID:2140535:Event:62212
DTSTAMP:20260521T181447Z
SUMMARY:Bioanalytical Methods Validation
DESCRIPTION:This training on bio-analytical methods validation will he
 lp you understand the clear, consistent and compliant approaches for i
 nstrumental, ligand binding, and cell based methods. A comparison of E
 MEA and FDA guidances will be presented.\nWhy should you Attend:\nBioa
 nalytical method validation includes various procedures that demonstra
 te that a particular method used for quantitative measurement of analy
 tes in a given biological matrix, such as blood, plasma, serum, or uri
 ne, is reliable and reproducible for the intended use. It is essential
  to employ well-characterized and fully validated bioanalytical method
 s to yield reliable results which can be satisfactorily interpreted.\n
 This webinar will discuss the best practices of Bioanalytical method v
 alidation, including components of a validation, how to include critic
 al reagents comparison, selectivity experiments, assessment of stabili
 ty. Concept of plate and experiment separation. Importance of communic
 ation between the development and the validation labs, accuracy of tra
 nsfer documents (SOPs). Predicate rules, support of clinical and non c
 linical sample analysis.\nUnderstand - Is validation a regulated activ
 ity? When to pull the trigger for validation? Is a stable label intern
 al standard always the best choice? Importance of suitability testing.
  Value of including critical reagents testing and suppliers. The limit
 s of an assay and where they come from.\nAreas Covered in the Seminar:
 \n\nFDA regulations and guidelines.\nLearning from the Crystal City FD
 A/Industry conference report.\nPhased approach for validation during d
 rug development\nLogistics of validation\nDevelopment of a master plan
  and SOP for validation\nPreparation and use of reference standards an
 d equipment\nDefining parameters and acceptance limits\nDefining valid
 ation experiments\nDocumenting and archiving raw and source data\nCons
 iderations for Microbiological and Ligand-binding Assays\nWorking with
  QC samples for quantitative results\nTo revalidate or not after metho
 d changes\nTransferring and using the method to routine\nUsing compute
 rs for automated method validation\nDocumentation for the FDA and othe
 r agencies\n\n\n\n\nFor more information visit https://medtechiq.ning.
 com/events/bioanalytical-methods-validation
DTSTART;TZID=America/New_York:20130807T100000
DTEND;TZID=America/New_York:20130807T111500
CATEGORIES:laboratory, compliance
LOCATION:Online Event
WEBSITE:http://www.complianceonline.com/ecommerce/control/trainingFocu
 s/~product_id=701769?channel=medtechiq
URL:http://www.complianceonline.com/ecommerce/control/trainingFocus/~p
 roduct_id=701769?channel=medtechiq
CONTACT:+1-650-620-3915
ORGANIZER;CN=Referral:https://medtechiq.ning.com/profile/Referral
ATTACH;FMTTYPE="image/jpeg":http://storage.ning.com/topology/rest/1.0/
 file/get/2562006570?profile=original
ATTENDEE;ROLE=REQ-PARTICIPANT;PARTSTAT=ACCEPTED;RSVP=TRUE;CN=Referral:
 https://medtechiq.ning.com/profile/Referral
END:VEVENT
END:VCALENDAR