Return-Path: Received: from vps.transocean.com by vps.transocean.com with LMTP id iMOgGNWH2FpiDQAAInt2oQ ; Thu, 19 Apr 2018 05:13:09 -0700 Return-path: Envelope-to: JOHN@TRANSOCEAN.COM Delivery-date: Thu, 19 Apr 2018 05:13:09 -0700 Received: from mail198.saveastamp.com ([199.68.176.198]:23867) by vps.transocean.com with esmtps (TLSv1:ECDHE-RSA-AES256-SHA:256) (Exim 4.89_1) (envelope-from ) id 1f98Qq-0000vv-5a for JOHN@TRANSOCEAN.COM; Thu, 19 Apr 2018 05:13:09 -0700 Received: by mail198.saveastamp.com id hr23sk1hso8v for ; Thu, 19 Apr 2018 08:12:05 -0400 (envelope-from ) From: "Microbiology Bootcamp" To: "JOHN@TRANSOCEAN.COM" Reply-To: henryt@Food-Safety-Solutions.org Date: Thu, 19 Apr 2018 08:02:49 -0400 Subject: FDA Validation Criteria and Guidance for FVM Microbiology MIME-Version: 1.0 Content-Type: multipart/alternative; boundary="_=aspNetEmail=_d542b53bc49c4cf797a6b78d746be981" X-Mailer: aspNetEmail ver 3.5.2.0 x-sbe: SBE_271e6178-181c-4649-a0d4-a5a6ffdc1088 List-Unsubscribe: mailto:henryt@Food-Safety-Solutions.org List-Unsubscribe-Post: List-Unsubscribe=One-Click Message-ID: X-Spam-Status: No, score=1.6 X-Spam-Score: 16 X-Spam-Bar: + X-Ham-Report: Spam detection software, running on the system "vps.transocean.com", has NOT identified this incoming email as spam. The original message has been attached to this so you can view it or label similar future email. If you have any questions, see root\@localhost for details. Content preview: Analytical Method Validation for the Detection of Microbial Pathogens in Foods and Feeds Presented By: Angela Bazigos Virtual Boot Càmp | Pre-recorded | Length: 180 minutes Register Now When a company is tasked with ensuring the safety of the nation’s food supply, it is imperative that laboratory methods needed to support regulatory compliance, investigations and enforcement, meet the highest analytical performance standards appropriate for their intended purposes, according to the FDA. For the development of standardized validation requirements for all regulatory methods used to dètect microbial pathogens and in your laboratories, it is critical that you continue to meet the highest standards possible. 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X-Spam-Flag: NO --_=aspNetEmail=_d542b53bc49c4cf797a6b78d746be981 Content-Type: text/plain; charset="UTF-8" Content-Transfer-Encoding: quoted-printable Analytical Method Validation for the Detection of=0D=0AMicrobial Pathogen= s in Foods and Feeds=0D=0APresented By: Angela Bazigos=0D=0AVirtual Boot = C=C3=A0mp =7C Pre-recorded =7C Length: 180 minutes=0D=0ARegister Now=0D=0A= =0D=0A=0D=0AWhen a company is tasked with ensuring the safety of the nati= on=E2=80=99s food supply, it is imperative that laboratory methods needed= to support regulatory compliance, investigations and enforcement, meet t= he highest analytical performance standards appropriate for their intende= d purposes, according to the FDA=2E For the development of standardized v= alidation requirements for all regulatory methods used to d=C3=A8tect mic= robial pathogens and in your laboratories, it is critical that you contin= ue to meet the highest standards possible=2E =0D=0A=0D=0AWhy You Should A= ttend=0D=0A=0D=0AJoin this virtual boot c=C3=A0mp, where food safety expe= rt Angela Bazigos will cover the latest FDA thinking and guidance documen= ts to assist you in re-establishing the requirements that need to be fulf= illed in the evaluation for microbial methods used in your testing labora= tories=2E This boot c=C3=A0mp will also re-establish performance evaluati= on (verification and validation) criteria, necessary for the use of comme= rcially-available diagnostic test kits and platforms=2E=0D=0A=0D=0AAngela= will describe the FDA=E2=80=99s evaluation criteria for methods to d=C3=A8= tect, identify and quantify all microbial analytes that may now be, or ha= ve the potential to be, associated with foods and feeds, i=2Ee=2E any mic= robiological organism of interest (target organism) or the genetic materi= al i=2Ee=2E DNA, RNA, toxins, antigens or any other product of these orga= nisms=2E=0D=0A=0D=0AThis boot c=C3=A0mp will cover the methodologies that= are also used by FDA labs=2E FDA applies them to educat=C3=ACon, inspect= ions, data collections, standard setting, investigation of outbreaks and = enforcement actions=2E=0D=0ASESSION 1:=0D=0ADuration: 60 minutes=0D=0AThi= s session will discuss FDA validation criteria and guidance for all FVM-d= eveloped or any existing method(s) that has been significantly modified=2E= =0D=0ASession Highlights=0D=0AIntroduction=0D=0APurpose and scope=0D=0AAd= ministrative authority and responsibilities=0D=0AGeneral responsibilities= of the originating laboratory=0D=0AMethod validation definition=0D=0AApp= licability=0D=0ARequirements=0D=0ACriteria and guidance for the validatio= n of FDA-related methods=0D=0AValidation: Definitions=0D=0AThe reference = method=0D=0AThe alternate method=0D=0AThe originating laboratory=0D=0AThe= collaborating laboratory=0D=0AThe method validation process=0D=0AEmergen= cy use=0D=0ANon-emergency use=0D=0AValidation criteria=0D=0AValidation cr= iteria for qualitative methods to d=C3=A8tect conventional microbial food= -borne pathogens=0D=0AValidation criteria for identification methods=0D=0A= Validation criteria for quantifiable methods to d=C3=A8tect conventional = microbial food-borne pathogens=0D=0AMethod validation operational aspects= =0D=0AGeneral considerations=0D=0AAssessment of validation results=0D=0AS= ESSION 2:=0D=0ADuration: 60 minutes=0D=0AThis session will cover the FDA=E2= =80=99s guidelines intended to support method validation efforts for deve= lopers of molecular-based assays e=2Eg=2E PCR, to be used to confirm the = identity of exclusion of isolated colonies=2E The methodologies from this= session can be used for either conventional or real time PCR assays=2E T= he session will also discuss how to confirm that results obtained by comm= ercially-available kit, are comparable to or exceed those obtained using = the reference method=2E=0D=0ASession Highlights=0D=0ACriteria and guidanc= e for the validation of FDA-related molecular-based assays=0D=0AInclusivi= ty and exclusivity=0D=0ATarget genes and controls=0D=0AComparison to the = reference method=0D=0ACriteria and guidance for the validation and verifi= cation of commercially available microbiological diagnostic kits and plat= forms=0D=0ADefinitions=0D=0AValidation of an alternative method=0D=0AVeri= fication=0D=0ACriteria=0D=0ACommercially-available microbiological diagno= stic kits, whose performance parameters have been fully validated in a mu= lti-laboratory collaborative study, monitored and evaluated by an indepen= dent accrediting body e=2Eg=2E AOAC-OMA, AFNOR, etc=2E=0D=0ACommercially-= available microbiological diagnostic kits, whose performance parameters a= re supported by data obtained through an independent laboratory validatio= n protocol and evaluated by an independent accrediting body e=2Eg=2E AOAC= -RI=2E=0D=0ASESSION 3:=0D=0ADuration: 60 minutes=0D=0AModifications to an= existing validated method may be made for any number of reasons and may = or may not affect the established validated performance parameters of the= original method, as per the FDA=2E There is no =E2=80=9Cone size fits al= l=E2=80=9D rule or set of rules to govern how a modification will be addr= essed=2E This session will describe how such modifications are evaluated = and the path to ensuring that the validated state remains intact=2E The s= ession will also present some SOPs that can be used in your laboratory to= meet the method validation requirements for the detection of microbial p= athogens in foods and feeds=2E=0D=0ASession Highlights=0D=0AMethod modifi= cation and method extension criteria for existing validated microbiology = methods=0D=0AMatrix extension=0D=0AMatrix extension guidance for new food= s from the same category used for the original or subsequent validation s= tudies=0D=0AMatrix extension guidance for new foods from a different cate= gory than that used for the original method validation study=0D=0APlatfor= m extension=0D=0ASOPs=0D=0AMethod development, implementation and validat= ion SOP=0D=0AFVM microbiology method validation study application=0D=0AGe= t answers to your questions in the Q=26A directly from the speaker=0D=0AR= egister Now=0D=0A=E2=9C=86 Call Now: 1-866-251-3060 and mention EFOOVBEM_= SB or email us at virtualbootcamp=40audioeducator=2Ecom=0D=0AWe hope you = found this message to be useful=2E=0D=0AIf you don=E2=80=99t wish to rece= ive any further communication, please click the unsubscribe link below=2E= Your request will be processed within 10 days=2E This is an advertisemen= t=2E =0D=0AAudio Educator =7C 2222 Sedwick Rd, Durham NC 27713 =7C 1-866-= 458-2965 =0D=0AThis message has been sent by Audio Educator=2E=0A=0A=0ATh= is message is intended for JOHN=40TRANSOCEAN=2ECOM=2E If you do not wish = to receive future emails, please click here: http://Incoming=2Esaveastamp= =2Eca/unsubstracker=2Easpx?=7B0=7D=7BJOHN=40TRANSOCEAN=2ECOM=7D=7B271e617= 8-181c-4649-a0d4-a5a6ffdc1088=7D=2E=0D=0A --_=aspNetEmail=_d542b53bc49c4cf797a6b78d746be981 Content-Type: text/html; charset="UTF-8" Content-Transfer-Encoding: quoted-printable <=21DOCTYPE html PUBLIC =22-//W3C//DTD XHTML 1=2E0 Transitional//EN=22 =22= http://www=2Ew3=2Eorg/TR/xhtml1/DTD/xhtml1-transitional=2Edtd=22>=0D=0A=0D=0A=0D=0A=0D=0AFDA Validation Criteria and Gui= dance for FVM Microbiology=0D=0A =0D=0A= =0D=0A=0D=0A --_=aspNetEmail=_d542b53bc49c4cf797a6b78d746be981--
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    =0D=0A
  • Method modification a= nd method extension criteria for existing validated microbiology methods<= /strong>
    • =0D=0A
      =0D=0A
    • Matrix extension
      • =0D=0A
        =0D= =0A
      • = Matrix extension guidance for new foods from the same category used for t= he original or subsequent validation studies
        • =0D=0A
      • Matrix extensi= on guidance for new foods from a different category than that used for th= e original method validation study
        • =0D=0A
      =0D=0A
    • Platform extension=0D=0A
    =0D=0A
  • SOPs
    • =0D=0A
      =0D=0A
    • Method deve= lopment, implementation and validation SOP
      • =0D=0A
    • FVM microbiology= method validation study application
      • =0D=0A
    =0D=0A
=0D= =0A=0D=0A=0D=0A=0D=0A=0D=0A=0D= =0A=0D=0A=0D=0A=0D=0A=0D=0A=0D=0A=0D=0A=0D=0A
Analytical Method Validation for the Det= ection of
Microbial Pathogens in Foods and Feeds
Presented By: Angela Bazigos
Virtual Boot C=26agrave;mp =7C Pre-= recorded =7C Length: 180 minutes
Register Now<= /u>


When a c= ompany is tasked with ensuring the safety of the nation=26rsquo;s food su= pply, it is imperative that laboratory methods needed to support regulato= ry compliance, investigations and enforcement, meet the highest analytica= l performance standards appropriate for their intended purposes, accordin= g to the FDA=2E For the development of standardized validation requiremen= ts for all regulatory methods used to d=26egrave;tect microbial pathogens= and in your laboratories, it is critical that you continue to meet the h= ighest standards possible=2E

Why You Should Attend

Join this virtual boot c=26agrave;mp, where food safety exper= t Angela Bazigos will cover the latest FDA thinking and = guidance documents to assist you in re-establishing the requirements that= need to be fulfilled in the evaluation for microbial methods used in you= r testing laboratories=2E This boot c=26agrave;mp will also re-establish = performance evaluation (verification and validation) criteria, necessary = for the use of commercially-available diagnostic test kits and platforms=2E=

Angela will describe the FDA=26rsquo;s evaluation criteria for m= ethods to d=26egrave;tect, identify and quantify all microbial analytes t= hat may now be, or have the potential to be, associated with foods and fe= eds, i=2Ee=2E any microbiological organism of interest (target organism) = or the genetic material i=2Ee=2E DNA, RNA, toxins, antigens or any other = product of these organisms=2E

This boot c=26agrave;mp will cover = the methodologies that are also used by FDA labs=2E FDA applies them to e= ducat=26igrave;on, inspections, data collections, standard setting, inves= tigation of outbreaks and enforcement actions=2E
SESSION 1: =
= Durati= on: 60 minutes
This session will discuss FDA validation criteria and guida= nce for all FVM-developed or any existing method(s) that has been signifi= cantly modified=2E
Session Highlights
=0D=0A
    =0D= =0A
  • = Introduction
    • =0D=0A
      =0D=0A
    • Purpose and scope
      • =0D=0A
    • Administrative authority and responsibilities
      • =0D=0A=
    • Gen= eral responsibilities of the originating laboratory
      • =0D=0A
    • = Method = validation definition
      • =0D=0A
    • Applicability
      • =0D=0A
    • Requireme= nts
      • =0D=0A
    =0D=0A
  • Criteria and guidance for the valida= tion of FDA-related methods
    • =0D=0A
      =0D=0A
    • Validation: = Definitions
      • =0D=0A
        =0D=0A
      • The reference method
        • =0D=0A=
      • The= alternate method
        • =0D=0A
      • The originating laboratory
        • =0D= =0A
      • = The collaborating laboratory
        • =0D=0A
      =0D=0A
    • The method validation= process
      • =0D=0A
        =0D=0A
      • Emergency use
        • =0D=0A
      • Non-emergenc= y use
        • =0D=0A
      =0D=0A
    • Validation criteria
      • =0D=0A
        =0D= =0A
      • = Validation criteria for qualitative methods to d=26egrave;tect convention= al microbial food-borne pathogens
        • =0D=0A
      • Validation criteria for ide= ntification methods
        • =0D=0A
      • Validation criteria for quantifiable me= thods to d=26egrave;tect conventional microbial food-borne pathogens
        • =0D=0A
      =0D=0A
    • Method validation operational aspects
      • =0D= =0A
        =0D=0A
      • General considerations
        • =0D=0A
      • Assessment of validation res= ults
        • =0D=0A
      =0D=0A
    =0D=0A
=0D=0A
SESSION 2: =
= Duratio= n: 60 minutes
This session will cover the FDA=26rsquo;s guidelines intend= ed to support method validation efforts for developers of molecular-based= assays e=2Eg=2E PCR, to be used to confirm the identity of exclusion of = isolated colonies=2E The methodologies from this session can be used for = either conventional or real time PCR assays=2E The session will also disc= uss how to confirm that results obtained by commercially-available kit, a= re comparable to or exceed those obtained using the reference method=2E <= /font>
S= ession Highlights
=0D=0A
    =0D=0A
  • Criteria and guidance for th= e validation of FDA-related molecular-based assays
    • =0D= =0A
      =0D=0A
    • Inclusivity and exclusivity
      • =0D=0A
    • Target genes and control= s
      • =0D=0A
    • Comparison to the reference method
      • =0D=0A
    = =0D=0A
  • Criteria and guidance for the validation and verification of com= mercially available microbiological diagnostic kits and platforms
    • =0D=0A
      =0D=0A
    • Definitions
      • =0D=0A
        =0D=0A
      • Validation = of an alternative method
        • =0D=0A
      • Verification
        • =0D=0A
      =0D= =0A
    • = Criteria
      • =0D=0A
        =0D=0A
      • Commercially-available microbiological d= iagnostic kits, whose performance parameters have been fully validated in= a multi-laboratory collaborative study, monitored and evaluated by an in= dependent accrediting body e=2Eg=2E AOAC-OMA, AFNOR, etc=2E
        • =0D= =0A
      • = Commercially-available microbiological diagnostic kits, whose performance= parameters are supported by data obtained through an independent laborat= ory validation protocol and evaluated by an independent accrediting body = e=2Eg=2E AOAC-RI=2E
        • =0D=0A
      =0D=0A
    =0D=0A
=0D=0A=0D=0A
SESSION 3:=
Duration: 60 minutes
Modifications to an existing validated metho= d may be made for any number of reasons and may or may not affect the est= ablished validated performance parameters of the original method, as per = the FDA=2E There is no =26ldquo;one size fits all=26rdquo; rule or set of= rules to govern how a modification will be addressed=2E This session wil= l describe how such modifications are evaluated and the path to ensuring = that the validated state remains intact=2E The session will also present = some SOPs that can be used in your laboratory to meet the method validati= on requirements for the detection of microbial pathogens in foods and fee= ds=2E
Session Highlights
Get answers to your questions = in the Q=26amp;A directly from the speaker
Register Now
=E2=9C=86 Call Now:= 1-866-251-3060 and mention EFOOVBEM_SB or email us at virtualbootcamp=40audioeducator=2Ecom
=0D=0A

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