3-Hour Boot Camp for the Detection of Microbial Pathogens in Foods and Feeds

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.

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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.

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.

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

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

Technology Targeting Molecular Mechanisms

Bioelectronic medicine is now at a crossroads of the future of medical research where healthcare, technology and science join.

In this blog Margot Puerta reports on the Bioelectronic Medicine: Technology Targeting Molecular Mechanisms symposium which took place in June. This three-day meeting had the aim of developing the field of bioelectronic medicine and brought together leading scientists and industry leaders from around the globe.

Technology is changing the world, including the world of pharmacological therapies that target molecular mechanisms. These therapies are expensive, difficult to administer, often toxic, and may be accompanied by lethal side effects. Through a convergence of molecular medicine, neuroscience and bioengineering, bioelectronic medicine seeks to develop cures that don’t require drugs or rely on them less heavily.

The second symposium, Bioelectronic Medicine: Technology Targeting Molecular Mechanisms was held June 12–14 in Saltsjöbaden, Sweden, presented by the Feinstein Institute for Medical Research, the Karolinska Institutet, and the Journal of Internal Medicine.

The field of bioelectronic medicine is aimed at interfacing electronics with nerves to specifically target the biological processes underlying disease. Bioelectronic medicine is now at a crossroads of the future of medical research where healthcare, technology and science join.

“With the discoveries that have been announced, and the research collaborations that are spanning the globe, the pace of bioelectronic medicine is accelerating,” said Kevin J. Tracey, MD, president and CEO of the Feinstein Institute and Editor in Chief of Bioelectronic Medicine. “As the global scientific home of bioelectronic medicine, it is important that the Feinstein Institute host a forum to discuss new findings and drive new discovery. We achieved that goal with this latest symposium.”

The three-day meeting brought together leading scientists and global experts from major institutions as well as industry leaders in biotechnology, including Galvani Bioelectronics, General Electric, GlaxoSmithKline, Medtronic and SetPoint Medical. The goal was to explore, define, and further develop the field of bioelectronic medicine. Session topics included: Defining Circuits, Clinical Updates, Molecular Targets, Neural Interfaces, Signal Processing, Disruptive Tools and Technology, and Accelerating Clinical Translation.

Presenters were encouraged to show their most recent advances. Many of the presentations included unpublished data, sparking thought-provoking discussion while contributing excitement about the latest developments in the field. At least one presenter was interrupted by spontaneous applause midway through the presentation. “I am inspired by the science, by the field advances, and by our collaborations in the short time since our groups hosted the last meeting in 2016,” said Peder Olofsson, MD, PhD, director of the Center for Bioelectronic Medicine at the Karolinska Institutet, and a chair of the symposia.

Read more at http://bit.ly/2KJTlu9