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.
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.
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.
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.
- 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 Available 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.
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
- Method Development, Implementation and Validation SOP
- FVM Microbiology Method Validation Study Application
Ms Angela Bazigos,
Touchstone Technologies Silicon Valley
Angela Bazigos.CEO of Touchstone Technologies Inc. She has 40 years of experience in the Life Sciences & Healthcare Industries. Experience combines Quality Assurance, Regulatory Compliance, Business Administration, Information Technology, Project Management, Clinical Lab Science, Microbiology, Food Safety, Turnarounds and Business Development. Past employers / clients include Roche, Novartis, Genentech & PriceWaterhouseCoopers. Positions include Chief Compliance Officer at Morf Media. Co-authored & prototyped 21 CFR 11 guidance with FDA. Co-authored Computerized Systems in Clinical Research w/ FDA. Patent on speeding up software compliance. Recently quoted in Wall Street Journal for using training to bring regulatory compliance to the Boardroom. National Trainer 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 Life Sciences.
- Anyone involved with Method Validation of Microbial Pathogen Detection
- FDA investigators
- Other regulatory agency investigators
- Anyone in a food manufacturer including:
- Safety officers
- Compliance and QA
- Shop floor