Return-Path: Received: from vps.transocean.com by vps.transocean.com with LMTP id 6JzuHd/jYVocKwAAInt2oQ ; Fri, 19 Jan 2018 04:26:07 -0800 Return-path: Envelope-to: JOHN@TRANSOCEAN.COM Delivery-date: Fri, 19 Jan 2018 04:26:07 -0800 Received: from mx.newscpt17.de ([185.11.253.151]:52316) by vps.transocean.com with esmtp (Exim 4.89_1) (envelope-from ) id 1ecVk5-0002rm-Iv for JOHN@TRANSOCEAN.COM; Fri, 19 Jan 2018 04:26:07 -0800 Content-Type: multipart/mixed; boundary="===============5149483069378155146==" DKIM-Signature: v=1; a=rsa-sha256; c=relaxed/relaxed; d=newscpt17.de; s=default; t=1516364716; bh=DXeBEYqwjMQNKceKXdrG3X+4M+RvaXxC9OLyaf7kjA4=; h=X-CSA-Complaints:Reply-To:Subject:From:To:List-Id: List-Unsubscribe:Date:Reply-To:From:Subject:Date:To: List-Unsubscribe:List-Id:X-CSA-Complaints; b=YGefJ4BCFY7lYyq1BZ6ofNMKJTIaQQOMIaE4piCNNRgveZJ8F6Zj3eMSawiPz5yu+ hZ4vUR4zVm6SGo2LHg1JEeQUOg+H3f1Za/JVljN6Ds/Kq+sNnX1S+i0Lm0ARgbb8FN Ni1GDrPj4EEOID+frOWmcrU+zY9C9sDsGlvpi54s= MIME-Version: 1.0 X-CSA-Complaints: Reply-To: Microbial Pathogens Detection Subject: FDA Validation Criteria and Guidance for FVM Microbiology From: Microbial Pathogens Detection To: BOUNCED_id_tdat_newsletter: 3495135 List-Id: <475626380> BOUNCED_id_tdat_nl_subscriber: 475626380 bounced_nl: true BOUNCED_tdat_nl_subscriber_pw: a2fbbf1269b6e082d34a526d26fed577 List-Unsubscribe: hermes_uid: 6085d37921f3e6551f854f834b5307a4 Date: Fri, 19 Jan 2018 12:25:16 -0000 Message-Id: <20180119122516.502B424160C@mx.newscpt17.de> X-Spam-Status: No, score=2.4 X-Spam-Score: 24 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: Sie können diesen HTML Newsletter nicht sehen? Dann verpassen Sie wirklich etwas. Rufen Sie folgende URL auf, um den Newsletter anzuzeigen: http://ea.newscpt17.de/_ns/5cf4f8766c1461757e5bbdd4209982af.html [...] Content analysis details: (2.4 points, 3.0 required) pts rule name description ---- ---------------------- -------------------------------------------------- 0.0 URIBL_BLOCKED ADMINISTRATOR NOTICE: The query to URIBL was blocked. See http://wiki.apache.org/spamassassin/DnsBlocklists#dnsbl-block for more information. [URIs: audioeducator.com] 0.0 T_SPF_HELO_TEMPERROR SPF: test of HELO record failed (temperror) -0.0 T_RP_MATCHES_RCVD Envelope sender domain matches handover relay domain 0.2 HEADER_FROM_DIFFERENT_DOMAINS From and EnvelopeFrom 2nd level mail domains are different -0.0 SPF_PASS SPF: sender matches SPF record 0.8 MPART_ALT_DIFF BODY: HTML and text parts are different 0.8 BAYES_50 BODY: Bayes spam probability is 40 to 60% [score: 0.4621] 0.0 HTML_MESSAGE BODY: HTML included in message 0.0 HTML_FONT_SIZE_LARGE BODY: HTML font size is large 0.6 KAM_ADVERT2 RAW: This is probably an unwanted commercial email... -0.1 DKIM_VALID Message has at least one valid DKIM or DK signature 0.1 DKIM_SIGNED Message has a DKIM or DK signature, not necessarily valid 0.0 T_HTML_TAG_BALANCE_CENTER Malformatted HTML X-Spam-Flag: NO --===============5149483069378155146== Content-Type: multipart/alternative; boundary="===============8233202293306775669==" MIME-Version: 1.0 --===============8233202293306775669== MIME-Version: 1.0 Content-Transfer-Encoding: 8bit Content-Type: text/plain; charset="utf-8" Sie können diesen HTML Newsletter nicht sehen? Dann verpassen Sie wirklich etwas. Rufen Sie folgende URL auf, um den Newsletter anzuzeigen: http://ea.newscpt17.de/_ns/5cf4f8766c1461757e5bbdd4209982af.html Um sich von diesem Newsletter abzumelden, rufen Sie folgende URL auf: http://ea.newscpt17.de/_u/5cf4f8766c1461757e5bbdd4209982af.html /// Can't see this html newsletter? You're really missing out. Visit this URL to view the newsletter: http://ea.newscpt17.de/_ns/5cf4f8766c1461757e5bbdd4209982af.html To instantly unsubscribe from our newsletter, visit this URL: http://ea.newscpt17.de/_u/5cf4f8766c1461757e5bbdd4209982af.html --===============8233202293306775669== MIME-Version: 1.0 Content-Transfer-Encoding: 8bit Content-Type: text/html; charset="utf-8" How the FDA are Trained for Medical Device Inspections VBC
Analytical Method Validation for the Detection of
Microbial Pathogens in Foods and Feeds
Presented By: Angela Bazigos
Virtual Boot Càmp | Date: Tuesday, February 06, 2018 | Length: 180 minutes | Time: 12:00 PM EST - 3:20 PM EST
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.

Why You Should Attend

Join this virtual boot càmp, where food safety expert 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 your testing laboratories. This boot càmp will also re-establish performance evaluation (verification and validation) criteria, necessary for the use of commercially-available diagnostic test kits and platforms.

Angela will describe the FDA’s evaluation criteria for methods to dètect, identify and quantify all microbial analytes that may now be, or have the potential to be, associated with foods and feeds, i.e. any microbiological organism of interest (target organism) or the genetic material i.e. DNA, RNA, toxins, antigens or any other product of these organisms.

This boot càmp will cover the methodologies that are also used by FDA labs. FDA applies them to educatìon, inspections, data collections, standard setting, investigation of outbreaks and enforcement actions.
SESSION 1:
Session Timings: 12:00 PM EST to 1:00 PM EST | Duration: 60 minutes
This session will discuss FDA validation criteria and guidance for all FVM-developed or any existing method(s) that has been significantly modified.
Session Highlights
  • Introduction
    • Purpose and scope
    • Administrative authority and responsibilities
    • General responsibilities of the originating laboratory
    • Method validation definition
    • Applicability
    • Requirements
  • Criteria and guidance for the validation of FDA-related methods
    • Validation: Definitions
      • The reference method
      • The alternate method
      • The originating laboratory
      • The collaborating laboratory
    • The method validation process
      • Emergency use
      • Non-emergency use
    • Validation criteria
      • Validation criteria for qualitative methods to dètect conventional microbial food-borne pathogens
      • Validation criteria for identification methods
      • Validation criteria for quantifiable methods to dètect conventional microbial food-borne pathogens
    • Method validation operational aspects
      • General considerations
      • Assessment of validation results
SESSION 2:
Session Timings: 01:10 PM EST to 02:10 PM EST | Duration: 60 minutes
This session will cover the FDA’s guidelines intended to support method validation efforts for developers of molecular-based assays e.g. PCR, to be used to confirm the identity of exclusion of isolated colonies. The methodologies from this session can be used for either conventional or real time PCR assays. The session will also discuss how to confirm that results obtained by commercially-available kit, are comparable to or exceed those obtained using the reference method.
Session Highlights
  • Criteria and guidance for the validation of FDA-related molecular-based assays
    • Inclusivity and exclusivity
    • Target genes and controls
    • Comparison to the reference method
  • Criteria and guidance for the validation and verification of commercially available microbiological diagnostic kits and platforms
    • Definitions
      • Validation of an alternative method
      • Verification
    • Criteria
      • Commercially-available microbiological diagnostic kits, whose performance parameters have been fully validated in a multi-laboratory collaborative study, monitored and evaluated by an independent accrediting body e.g. AOAC-OMA, AFNOR, etc.
      • Commercially-available microbiological diagnostic kits, whose performance parameters are supported by data obtained through an independent laboratory validation protocol and evaluated by an independent accrediting body e.g. AOAC-RI.
SESSION 3:
Session Timings: 02:20 PM EST to 03:20 PM EST | Duration: 60 minutes
Modifications 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. There is no “one size fits all” rule or set of rules to govern how a modification will be addressed. This session will describe how such modifications are evaluated and the path to ensuring that the validated state remains intact. The session will also present some SOPs that can be used in your laboratory to meet the method validation requirements for the detection of microbial pathogens in foods and feeds.
Session Highlights
  • Method modification and method extension criteria for existing validated microbiology methods
    • Matrix extension
      • Matrix extension guidance for new foods from the same category used for the original or subsequent validation studies
      • Matrix extension guidance for new foods from a different category than that used for the original method validation study
    • Platform extension
  • SOPs
    • Method development, implementation and validation SOP
    • FVM microbiology method validation study application
Get answers to your questions in the Q&A directly from the speaker
Register Now
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