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.
- Purpose & Scope
- Administrative Authority & Responsibilities
- General Responsibilities of the Originating Laboratory
- Method Validation Definition
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
- Validation of an Alternative Method
- 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