Analytical Method Validation for the Detection of Microbial Pathogens in Foods and Feeds

Product Id : FDA175
Instructor : Angela Bazigos
Jul 25, 2019 All Day Available | 180 Minutes (Boot Camp)

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Overview: 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 detect microbial pathogens and in your laboratories, it is critical that you continue to meet the highest standards possible.

Why Should You Attend:

Join this virtual boot camp, 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 camp 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 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.
This boot camp will cover the methodologies that are also used by FDA labs. FDA applies them to education, inspections, data collections, standard setting, investigation of outbreaks and enforcement actions.

Session 1: Introduction and Guidance for FDA Related Methods

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 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

Session 2: Method Validation of Molecular-Based Assays & Commercially available Microbiological Diagnostic Kits

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: Method Modification for existing Validated Methods and SOPs

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
  • SOP
    • Method development, implementation and validation SOP
    • FVM microbiology method validation study application

Who will benefit:

  • Anyone involved with method validation of microbial pathogen detection
  • FDA investigators
  • FDA food inspectors
  • Other regulatory agency investigators
  • Operations
  • Safety officers
  • Compliance and QA
  • Shop floor
  • Washers
  • Microbiologists
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. Experience combines Quality Assurance, Regulatory Compliance, Business Administration, Information Technology, Project Management, Clinical Lab Science, Microbiology, Food Safety & Turnarounds. Past employers / clients include Royal Berkshire Hospital, Roche, Novartis, Genentech, PriceWaterhouseCoopers & Stanford Hospital. Positions include Chief Compliance Officer : http://morflearning.com/angelabazigos/, Director of QA and MIS Director.  Co-authored & prototyped 21 CFR 11 guidance with FDA.  Co-authored Computerized Systems in Clinical Research w/ FDA & DIA:

http://www1.diahome.org/~/media/4FA562336EBD46C58CDC43A8B7773095.ashx Patent on speeding up software compliance https://www.google.com/patents/US8266578

Recently quoted in Wall Street Journal for using training to bring regulatory compliance to the Boardroom : http://blogs.wsj.com/riskandcompliance/2015/07/24/using-training-to-bring-compliance-to-boardrooms/

Includes training for Society of Quality Assurance. Comments / collaborates with FDA on new guidance documents,Former President of Pacific Regional Chapter of Society of Quality Assurance. Stanford’s Who’s Who for LifeSciences: http://www.stanfordwhoswho.com/Angela.Bazigos.7144112.html#overview  


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