Analytical Method Validation Criteria for Microbial Pathogens
Analytical Method Validation for the Detection of
Microbial Pathogens in Foods and Feeds
Presented By: Angela Bazigos
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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 You Should 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 Details
Session 1: Introduction and Guidance for FDA Related Methods

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

Length: 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 3: Method Modification for existing Validated Methods and SOPs

Length: 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.
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
About Our Speaker
Angela BazigosAngela Bazigos is the CEO of Touchstone Technologies Inc. She has 40 years of experience in the Life Sciences & Healthcare Industries. Her experience combines Quality Assurance, Regulatory Compliance, Business Administration, Information Technology, Project Management, Clinical Lab Science, Microbiology, Food Safety, Turnarounds and Business Development. More Info

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