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      3-Hour Boot Camp on Analytical Method Validation for the Detection of Microbial Pathogens in Foods and Feeds in Fremont


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      March 4, 2019

      Monday   9:00 AM - 3:00 PM

      Online Event
      Fremont, California 94539

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      EVENT DETAILS
      3-Hour Boot Camp on Analytical Method Validation for the Detection of Microbial Pathogens in Foods and Feeds

      Overview

      All methodologies described in this presentation are also used by FDA labs. FDA applies them to education, inspections, data collections, standard setting, investigation of outbreaks and enforcement actions.
      Why should you Attend

      This presentation uses the latest FDA thinking and guidance documents to assist you in re-establishing those requirements that need to be fulfilled in the evaluation for microbial methods used in your testing laboratories.

      It also re-establishes performance evaluation (verification & validation) criteria, necessary for the use of commercially-available diagnostic test kits and platforms.

      The presentation further describes evaluation criteria for methods to detect, 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.

      Areas Covered in the Session

      Session #: 1
      Duration: 1 hour
      Learning Objectives: This section sets the context for the overall presentation and then provides validation criteria and guidance for all FVM-developed or any existing method(s) that has been significantly modified.

      Introduction

      Purpose & Scope
      Administrative Authority & 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 Detect Conventional Microbial Food-borne Pathogens
      Validation Criteria for Identification Methods
      Validation Criteria for Quantifiable Methods to Detect
      Conventional Microbial Food-borne Pathogens
      Method Validation Operational Aspects
      General Considerations
      Assessment of Validation Results

      BREAK -

      Session #: 2
      Duration: 1 hour
      Learning Objectives: This session describes 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. Methodologies from this session can be used for either conventional or real time PCR assays.
      The session then describes how to confirm that results obtained by commercially-available kit, are comparable to or exceed those obtained using the reference method.

      Criteria and Guidance for the Validation of FDA-related molecular Based Assays

      Inclusivity & Exclusivity
      Target Genes & Controls
      Comparison to the Reference Method

      Criteria and Guidance for the Validation and Verification of Commercially Availbale 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

      BREAK -

      Session #: 3
      Duration: 1 hour
      Learning Objectives: 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. There is no "one size fits all"rule or set of rules to govern how a modification will be addressed. This session describes how such modifications are evaluated and the path to ensuring that the validated state remains intact.

      Finally, this session presents some SOPs that can be used in your laboratory to meet above method validation requirements for the detection of microbial pathogens in foods and feeds.

      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
      Q&A

      Who Will Benefit

      Anyone involved with Method Validation of Microbial Pathogen Detection
      FDA Investigators
      Other Regulatory Agency Investigators
      Anyone in a Food Manufacturer including:
      Operations
      Safety Officers
      Compliance and QA
      Shop Floor
      Washers
      Microbiologists Etc.
      FDA Food Inspectors

      Speaker Profile
      Angela Bazigos is the CEO of Touchstone Technologies Inc. She has degrees in Microbiology and Computing and 40 years of experience in the Life Sciences, Healthcare & Public Health Services.

      Cost: Payment required - $290. One Attendee https://www.traininng.com/webinar/-200625live?channel=eventful-march_2019_SEO

      Categories: Conferences & Tradeshows

      Event details may change at any time, always check with the event organizer when planning to attend this event or purchase tickets.