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Validity : 13th Apr'24 to 23rd Apr'24
Analytical Method Validation for the Detection of Microbial Pathogens in Foods and Feeds
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 definitaion
- 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
BREAK –
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.
BREAK –
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
SOPs
- Method development, implementation and validation SOP
- FVM microbiology method validation study application
Q&A -
Overview of the webinar
When your 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. Development of standardized validation requirements for all regulatory methods used to detect microbial pathogens, used in your laboratories, it is critical that you continue to meet the highest standards possible.
Who should attend?
. Anyone involved with Method Validation of Microbial Pathogen Detection
. FDA investigators
. Other regulatory agency investigators
. Anyone in a food manufacturer including:
o Operations
o Safety officers
o Compliance and QA
o Shop floor
o Washers
o Microbiologists
o Etc.
. FDA Food Inspectors
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.
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.
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.
Faculty - Mz.Angela Bazigos
Angela Bazigos, is the CEO of Touchstone Technologies, Inc. She has 40 years of experience working in hospitals and Pharma industry. Her background includes companies like Roche, Novartis, Genentech and PricewaterhouseCoopers in GLP, GCP, GMP, Medical Device and Data Integrity Roles. She has held positions such as Chief Compliance Officer, QA Director and has acted on behalf CEO for communications with FDA.
Ms. Bazigos is a Past President of PRCSQA, a member of the SQA CVIC, ASQ, DIA and RAPS. She works closely with the FDA on behalf of her clients. She consults to Life Science Investment Groups as well as to Pharma / Biotech / Medical Device companies on compliance matters, including strategy, submissions, quality assurance and remediation following action by the FDA. Has contributed to prototyping of 21 CFR 11 & CSV before promulgation to industry.
Ms. Bazigos co-authored Computerized Systems in Clinical Research / Current Data Quality and Data Integrity Concepts with FDA, DIA and Academia. She holds a patent in speeding up software validation. She has been on the board for UC Berkeley’s Business School for Executive Education in Life Sciences and is now on the Stanford Who’s Who Registry for contributions to the Life Sciences industry.