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U.S. Department of Health and Human Services

Training and Continuing Education

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ORA U Course Catalog 2013 - LABORATORY

 

Course ID:            LB205
Course Title:         Basic Mass Spectrometry
 
Course Description:   This is an introductory level course for analysts who are or will be performing sample analysis using mass spectrometry (MS). The course will assume basic knowledge of Gas Chromatography (GC) and/or Liquid Chromatography (LC).  The course will discuss the components and the fundamentals of the GC/MS and LC/MS operation. Basic concepts for method development will also be covered. The routine and preventative maintenance of the MS system normally performed by the analyst will be discussed.
 
Course Objectives:
Upon completion of this course, the participant will be able to:
1.       Identify the basic principles and techniques of mass spectrometry.
2.       Interpret mass spectrometric data.
3.       Acquire a general understanding of ionization techniques and data interpretation.
 
Target Audience: Analysts who are or will be performing sample analysis using mass spectrometry (MS).
 
Prerequisites: Have completed the ORA New Hire training curriculum, including the audit (FDA, Level I
 
Course Duration: 4.5 Days
CEU: 3.4
 
Course ID:            LB208
Course Title:         Spectroscopy
 
Course Description: This is a foundation level course for chemists. The course will focus on spectroscopic techniques including: UV-VIS, Fluorescence, NIR, IR, Raman, ICP-MS, ICP-AES, and XRF. It will consist of lectures, demonstrations, and hands-on laboratory sessions. It will provide students with the knowledge, skills, abilities, and techniques to enhance their analytical and problem solving skills.
 
Course Objectives:
Upon completion of this course, the participant will be able to:
  1. Employ the theory, components, capability, and applications of common spectroscopic techniques such as UV-VIS, Fluorescence, NIR, IR, Raman, ICP-MS, ICP-AES, and XRF.
  2. Apply these techniques to method development, regulatory analysis, complaint samples, and unknowns.
  3. Demonstrate data analysis/interpretation for the purpose of deriving qualitative and quantitative information on samples.
  4. Recognize the appropriate qualification procedures for UV-VIS, Fluorescence, NIR, IR, Raman, ICP-MS, ICP-AES, and XRF methods.
 
Target Audience: This course is designed for Chemists who completed their ORA New Hire training curriculum and performs lab analysis. 
 
Prerequisites: Prior to attending, nominees must have completed their ORA New Hire training curriculum, including the audit (FDA: Level I)
 
Course Duration: 4.5 Days
CEU: Pending
 
Course ID:  LB211 
Course Title:  Allergen Testing 
 
Course Description:  In this hands-on Train-the-Trainer course, participants analyze food samples for food allergens.  Included are the selection and preparation of controls, the use of replicates, and the use of the
required analytical workbooks designed to facilitate data analysis and communication. Operating
practices, procedures, and different test kits used by the FDA in food allergen testing are
demonstrated to Analysts.
 
References to prior cases and events are used to emphasize the importance of GLP (Good
Laboratory Practices), the importance of stringent data interpretation, and the use of tests-of reasonability
in avoiding potential pitfalls. Personal interaction with the trainers assist in developing in-depth understanding of the principles and methodology of food allergen testing.  How to interpret data from operational and theoretical perspectives will be emphasized. Future trends in food allergen method development are presented. Participants will serve as the trainer/resource at their laboratory for food allergen testing. The course includes an analytical assignment to be completed at the Analyst’s laboratory within 30 days of completing the course.
 
Course Objectives:
Upon completion, participants will be able to:
  1. Develop hands-on proficiency using commercial ELISA (Enzyme-Linked Immuno-Sorbent Assay) food allergen test kits.
  2. Discuss the advantages and limitations of ELISA technology for detecting allergens in food
  3. Select and prepare controls and replicates and understand their role in ELISA food allergen testing.
  4. Demonstrate the workbook approach to reporting analytical data and troubleshooting performance problems.
 
Target Audience:  Analysts from federal, state, or local laboratories who are or will be performing food allergen testing within 30 days of the course end.
 
Prerequisites:  Before attending, nominees must obtain:
  1. Management concurrence to act as a Trainer/Resource role at their laboratory for food allergen testing.
  2. Level 1 Analyst certification.
 
Course Completion Requirements:
To successfully complete this course and receive a course certificate with Continuing Education
Units* (CEUs), each participant will be required to:
  1. Complete pre-course assignments
  2. Be on time and attend the entire course
  3. Participate in class discussions, exercises, workshops and presentations
  4. Pass the course assessment(s)
  5. Complete the analytical post-course assignment
 
Course Duration:  Pending
CEU:  Pending

Course ID:            LB215
Course Title:         Introduction to Pharmaceutical Inspections for Analysts
 
Course Description:  Analysts who may participate in team pharmaceutical inspections learn basics, sources, materials, and guidance(s). Data and analysis requirements at each manufacturing step from bulk state to finished product are covered in the classroom. Participants will review and write actual 483s with guidance from FDA regulatory and inspectional experts. Lectures and exercises are reinforced by a day at a pharmaceutical plant.
 
Course Objectives:
Upon completion of this course, the participant will be able to:
  1. Summarize the basic requirements for analysts during inspections.
  2. Identify potential violations within the context of current requirements.
  3. Document findings in accurate reports that support legal cases.
 
Target Audience:  Novice analysts who may participate in team pharmaceutical inspections of either domestic or imported products.
 
Prerequisites:  Prior to attending, nominees must:
  1. Have completed their ORA New Hire training curriculum, including the audit (FDA Level I).
  2. Plan to perform pharmaceutical inspections as part of a team inspection.
  3. Have been on at least one quality control test laboratory inspection (desirable).
 
Course Duration: 8.5 Days
CEU: Pending
 
Course ID:            LB221
Course Title:         Can Seam Analysis
 
Course description: This course prepares FDA analysts to make evaluations on canned food container integrity. The course includes instruction on low acid canned food regulations, can seam evaluations and integrity testing. Students will have lectures, demonstration laboratory sessions and hands-on laboratory session in this training course.
 
Course Objectives:
Upon completion of this course, the participant will be able to:
  1. Apply the principles and concepts of low acid canned food regulations pertaining to container integrity.
  2. Identify appropriate laboratory procedures in evaluating can seams for proper closures.
  3. Identify container defects in metal, glass, and flexible packaging.
 
Target audience: This course is being offered to analysts that may be required to evaluate can seam integrity.
 
Prerequisites: Level I Analyst Certification
 
Course Duration: 4.5 Days
CEU: 3.3
 
Course ID:            LB227
Course Title:         Sensory Analysis of Seafood Products
 
Course Description: This course is presented to assist sensory analysts to standardize their sensory values with those values of decomposition as defined by national sensory analysis of specialists. The course assess product by examining the quality attributes of color, texture, species, substitution, evidence of mishandling, or adverse storage. The analysts evaluate decomposition in seafood product by becoming aware of the significance as well as the limitation of the following indicators: Indole, Cadaver Putrescine, Histamine, etc. The species of fish examined at the course vary from year–to–year.
 
Course Objectives:
Upon completion of this course, the participant will be able to:
  1. Evaluate sensory values of decomposition as defined by national sensory specialists for performing sensory analysis of seafood products.
  2. Apply quality attributes (i.e., color, texture, odor, species, substitution, evidence of mishandling or adverse storage) when evaluating seafood products.
 
Target Audience: Laboratory analysts who currently perform sensory analysis of seafood products for regulatory compliance or laboratory analysts who will be assigned to work in the sensory area.
 
Prerequisites: Level I Analyst Certification
 
Course Duration: 4.5 Days
CEU: 3.4
 
Course ID:            LB235
Course Title:         Fundamentals of Regulatory Microbiology
 
Course Description: The course is designed to instruct FDA microbiologists on official methodologies used in FDA laboratories for regulatory analysis of foods. The course includes both lecture and hands-on laboratory exercises for the detection of various pathogens in foods. Requirements for satisfactory completion of the course include passing a written exam (>70% score) at the end of each week of the training course. Once all requirements have been satisfied, a certificate of completion will be issued to the participant.
 
Students should come prepared to work with virulent microbial pathogens. Personal protective equipment (PPE) and attire are required. The laboratory sessions will use various pathogens including L. monocytogenes which may have an adverse effect on pregnancies. All pathogens used may also have a potential health risk for immunocompromised individuals.
 
Course Objectives:
Upon completion of this course, the participant will be able to:
  1. Analyze a variety of food samples and determine if the products are adulterated by microbial pathogens.
  2. Apply microbiological isolation and identification techniques for microorganisms of sanitary and/or public health significance.
  3. Demonstrate proper laboratory techniques using prescribed methods for designated foodborne pathogens.
  4. Acquire fundamental knowledge of foodborne pathogens, detection methodologies, method validation and subtyping methods.
 
Target Audience: Newly hired FDA microbiologists with priority given to field analysts. This course is required for Level I Analyst Certification.
 
Prerequisites: New hire Microbiologists preferably with 3 months of regulatory microbiology analysis experience. Familiarity with VITEK and VIDAS would be beneficial.
 
Course Duration: 9.5 Days
CEU: 6.9
 
Course ID: LB236 
Course Title: Regulatory Science
 
Course Description:
The course will examine the interrelationship between the analyst, investigations branch, compliance branch and center reviewers with regard to analytical packages. Course content includes: relationship between FDA laboratories and other agency components; discussion of regulatory references; method selection, validation and verification; overview of FACTS; sample accountability; sample types; ISO 17025 requirements.
 
Course Objectives:
  1. Generate accurate and defensible worksheets for regulatory sample analysis.
  2. Outline compliance programs, reference guidance documents and assignments.
  3. Identify the regulatory significance of sample accountability: integrity and chain of custody.
  4. Apply the appropriate concepts of method selection, verification, or validation to a particular analytical situation.
 
Target Audience:  The course is primarily designed for newly hired laboratory analysts however newly hired physical science technicians and laboratory management new to the agency are encouraged to attend.
 
Prerequisite/Criteria for Attendance
This course is required for Level I Analyst certification. Course participants should have completed all ORA U web-based courses that pertain to the material covered in this course.
These courses include but are not limited to:
PHDV60 A Tour of The FDA
LB6101 Laboratory References
LB6102 Laboratory Method Selection
LB6103 FACTS Laboratory Overview
LB6106 Analytical Worksheets
LB6107 FACTS Analytical Results & Time Reporting
LB6108 Sample Accountability
LB6109 FACTS Sample Accountability
LB6110 Introduction to ISO 17025 Lab Management
FDA46 Courtroom Testimony
 
Course Duration: 3.5 Days
CEU: 2.6
 
Course ID:            LB237
Course Title:         Fundamentals of Regulatory Chemistry
 
Course Description: This course provides an introduction to FDA regulatory analytical techniques for chemists. Participants will receive a brief review of basic theory and application of analytical techniques including: spectroscopy, gas and liquid chromatography, mass spectrometry, elemental analysis, and emerging techniques.
 
 
Course Objectives:
Upon completion of this course, the participant will be able to:
  1. Demonstrate basic knowledge of the various types of analytical techniques in FDA chemistry laboratories.
  2. Apply practical regulatory applications of instrumentation used in FDA chemistry laboratories.
  3. Recognize the principles of laboratory QA and QC procedures applicable to regulatory analyses.
 
Target Audience: This is an introductory course with hands-on laboratory sessions intended for chemists who have or are in the process of completing all required ORA U web based training modules for Level I Analyst Certification.   This course would also be appropriate for newly hired management unfamiliar with the scope of FDA chemical analyses.
 
Prerequisites: This course is required for Level I Analyst certification. This course assumes basic knowledge of the theory of chromatography and spectroscopy.
 
Course Duration: 4 Days
CEU: 3.3
 
Course ID:            LB241
Course Title:             Separation Science
 
Course Description: The course will focus on both the theoretical aspects and practical applications in regulatory analyses through lectures and laboratory sessions. It will provide the students with the principles surrounding the science of chromatography as well as the knowledge, skills and abilities in chromatographic techniques to enhance their analytical and problem solving skills. Subject areas and laboratory sessions are as follows:
 
Lectures:
1.       Fundamentals of Separation Science
2.       Retention Mechanism LC
3.       Colum Characterizations LC
4.       Retention Mechanism GC
5.       Method Development LC
6.       Instrumentation LC
7.       Chiral Separations
8.       Electrophoresis
9.       Instrumentation GC – Injection
10.   Instrumentation GC – Detection
11.   Regulatory Applications
 
Laboratory Sessions:
1.       Lab #1 LC C8
2.       Lab #2 LC C18
3.       Lab #3 GC
4.       Lab #4 Troubleshooting
 
Course Objectives:
Upon completion of this course, the participant will be able to:
  1. Apply the principles of separation techniques such as GC, LC and TLC to regulatory analysis and method development.
  2. Describe the other separation techniques such as electrophoresis and Chiral Separation.
  3. Demonstrate the basic operation of GC and LC instrumentation for regulatory analysis.
 
Target Audience: This course is designed for Analysts using the principles of separation techniques and who are expected to utilize this training in their current position or in the near future.
 
Prerequisites:   Prior to attending, nominees must have completed the ORA New Hire training curriculum, including the audit (FDA: Level I)
 
Course Duration: 3.5 Days
CEU: 2.5
 
Course ID:            LB251
Course Title:        Sensory Workshop for Investigators
 
Course Description: This course is designed to train investigators to be first line defense in the examination of the quality attributes of color, texture, species, substitution, and evidence of mishandling or adverse storage of imported fish.
 
Course Objectives:
Upon completion of this course, the participant will be able to:
  1. Evaluate sensory values of decomposition as defined by national sensory specialists for performing sensory analysis of seafood products.
  2. Apply quality attributes (i.e., color, texture, odor, species, substitution, evidence of mishandling or adverse storage) when evaluating seafood products.
Outline proper sampling areas and techniques for fresh and frozen fish products.
 
Target Audience: Investigators (CSO’s and CSI’s) who inspect/collect fresh and frozen seafood products for regulatory compliance on a routine basis.
 
Prerequisites: CSO’s must have completed their Level I Investigator training curriculum (including the audit). Participants must not have attended this training course within the last two (2) years.
 
Course Duration: 3.5 Days
CEU: 2.5
 
Course ID:            LB252
Course Title:   X-Ray Fluorescence (XRF) Workshop for Investigators
 
Course Description: FDA has been working toward the development of XRF portable analytical capability in order to identify toxic elements in foods, dietary supplements, Asian patent medicines, and some other regulated products. The initial evaluation period for these devices is complete; a specific portable XRF (Innov-X, model X-5000) has been identified and acquired. A field implementation trial was also successfully completed. The plan is to deploy these devices to investigators located at important ports of entry once training has been completed. While the focus of interest for toxic elements is primarily for the following five elements: Lead (Pb), Cadmium (Cd), Mercury (Hg), Arsenic (As), and Selenium (Se), additional media and additional analyte targets may be identified in the future.
 
This workshop is composed of both theory and hands-on application of these devices appropriate for the needs and capabilities of the investigations staff that reflects the “situational realities” of the field. The workshop will cover not only how to operate and utilize these devices for identifying samples for laboratory analysis, but also how to use these devices safely. Users will be expected to satisfactorily complete a proficiency activity at the end of the workshop.
 
Course Objectives:
Upon completion of this workshop, the participant will be able to:
  1. Provide training to investigators and chemists to use portable XRF devices to identify FDA regulated products that are potentially “violative” for sample collection and laboratory analysis.
  2. Outline how to use these devices safely, in regard to the X-rays generated by these devices.
  3. Discuss the principles of x-ray fluorescence and how to apply these principles for the unequivocal, qualitative identification of several elements in several regulated products.
  4. Identify how to critically evaluate XRF spectra for positive qualitative element identification.
 
Target Audience: It is requested that the selected investigators have current experience and knowledge at working at a courier hub; have a strong background in chemistry and prior food inspection experience; and experience and knowledge of Compliance Program Guidance Manuals for toxic elements in foods and house wares. It is requested that the analysts attending this course should be chemists associated with the metals program. 
 
Criteria for Attendance: Level I Investigator Certification
 
Course Duration: 4 Days
CEU: Pending
 
Course ID:            LB253
Course Title:         X-Ray Fluorescence (XRF) Workshop for Laboratory Analysts
 
Course Description: FDA has been working toward the development of XRF portable analytical capability in order to identify toxic elements in foods, drugs, dietary supplements, Asian patent medicines, and some other regulated products. The initial evaluation period for these devices is complete and a field implementation trial was also successfully completed. The plan is to deploy these devices to investigators and analysts located at important ports of entry as well as in the laboratory once training has been completed. While the focus of interest for toxic elements is primarily for the following five elements: Lead (Pb), Cadmium (Cd), Mercury (Hg), Arsenic (As), and Selenium (Se), additional media and additional analyte targets may be identified in the future. This workshop is composed of both theory and hands-on application of these devices appropriate for the needs and capabilities of the agency that reflects the “situational realities” of the field. The workshop will cover not only how to operate and utilize these devices for identifying samples for laboratory analysis, but also how to use these devices safely. Users will be expected to satisfactorily complete a proficiency activity at the end of the workshop.
 
Course Objectives:
Upon completion of this workshop, the participant will be able to:
  1. Provide training to investigators and chemists to use portable XRF devices to identify FDA regulated products that are potentially “violative” for sample collection and laboratory analysis.
  2. Outline how to use these devices safely, in regard to the X-rays generated by these devices.
  3. Define the principles of x-ray fluorescence and how to apply these principles for the unequivocal, qualitative identification of several elements in several regulated products.
  4. Assess and evaluate XRF spectra for positive qualitative element identification.
 
Target Audience: It is requested that the selected analysts have current experience and knowledge in chemistry, biochemistry, radiology or engineering. Analysts should have experience and knowledge of Compliance Program Guidance Manuals for toxic elements in foods and house wares. Analysts chosen for participation will begin to implement testing using the XRF for both special assignments and compliance program testing.
 

It is requested that the analysts attending this course should or could be associated with the metals program or other XRF associated testing assignments.
 
Prerequisite: Level I Analyst certification
 
Course Duration: 5 Days
CEU: Pending
 
Course ID:            LB302
Course Title:         Cyclospora Identification
 
Course Description: This 5 day course on foodborne and waterborne parasites covers microscopic and molecular detection methods. A mix of didactic and laboratory sessions are used for instruction. Candidates must complete pre-course assignments before class sessions begin. Bacteriological Analytical Manual (BAM) methods, as well as alternate laboratory methods using molecular techniques, are covered. Concentration is on Cyclospora, Cryptosporidium and Giardia. Several other parasites of concern to the FDA are included. After course sessions are completed, the FDA will conduct proficiency tests to assess preparedness for potential outbreaks caused by foodborne and waterborne parasites.
 
Course Objectives:
Upon completion of this course, the participant will be able to:
  1. Recognize the infectious potential of foodborne and waterborne parasites
  2. Discuss the basic biology and life cycle of specific parasites
  3. Isolate and identify parasites using microscopic and molecular methods from selected sample matrices
  4. Interpret data generated by molecular methods
 
Target Audience: The course is for analysts who will be assigned to test FDA-regulated products for foodborne and waterborne parasites. Analysts must already be proficient with conventional and real-time PCR before attending this course.
 
Prerequisite: Before attending, nominees must have completed their Level I Analyst Certification
  1. Attended either the Fundamentals of Real-Time PCR Method (LB310) or FERN Real-Time PCR (LB506) training course
  2. Completed pre-course assignments
 
Course Duration: 5 Days
CEU: Pending
 
Course ID:            LB305
Course Title:         Advanced Chromatography
 
Course Description: The course will focus on both the theoretical aspects and practical applications in separation science through lectures and laboratory sessions. It will provide the students with the advanced principles surrounding the science of chromatography as well as knowledge of chromatographic principles and procedures.
 
Course Objectives:
Upon completion of this course, the participant will be able to:
1.       Acquire knowledge of separation techniques such as GC, LC, UPLC, IC, CE, and SPE.
2.       Determine the best approach for separation of complex samples.
3.       Identify strategies for method development.
 
Target Audience: This course is targeted for experienced analysts and research chemists currently working in chromatography.
 
Prerequisites:
  1. Have a minimum of two (2) years chromatography experience and currently working in chromatography
  2. Not have taken the course in the last three (3) years
  3. Foundation: Separation Science (LB241) training course
  4. Have completed their ORA New Hire training curriculum, including the audit (FDA: Level I)
 
Course Duration: 4.5 Days
CEU: 3.2
 
Course ID:            LB306
Course Title:         Colors Analysis for FDA Regulated Products
 
Course Description: This is a national training course for colors analysts to review the regulatory methods available and outline the nuances of the different methods available. The National Check Sample program will be reviewed. A complete review of private laboratory reviews as well as the database will also be covered in this course. The course will be lecture as well as a series of hands-on laboratory sessions.
 
Course Objectives:
Upon completion of this course, the participant will be able to:
  1. Identify standard ways to select methods for the analysis of both food and cosmetic color samples.
  2. Outline the nuances of the different color methods used for regulatory analysis.
  3. Illustrate allowable manipulations versus unacceptable deviations of color methods.
  4. Outline the National Check Sample program and private laboratory reviews of industry color sample packages.
 
 
Target Audience:
  1. This course is for analysts with at least five (5) year experience working for the FDA; two (2) year experience working in the area of colors analysis; and spend at least one third of their analytical time working in the colors area.
  2. Analysts must be familiar with and have used the majority of color methods available.
  3. Analysts must also be familiar with UV/VIS instrumentation and scans produced using this type instrumentation to analyze a color sample.
 
 
Prerequisites: Level I Analyst Certification
 
Course Duration: 4.5 Days
CEU: 3.2
 
Course ID:            LB310
Course Title:         Fundamentals of Real-Time PCR
Course Description: This course will focus on applying real-time PCR techniques for the detection of foodborne bacterial pathogens. The course is targeted towards FDA Microbiologists performing regulatory analysis. The course focuses on real-time PCR instrument platforms and DNA extraction procedures currently used in FDA Laboratories. Real-time PCR Methods currently in the BAM will be highlighted.
 
Course Objectives:
Upon completion of this course, the participant will be able to:
  1. Illustrate basic principles and applications of real-time PCR.
  2. Demonstrate good PCR practices and techniques.
  3. Apply real-time PCR techniques across multiple instrument platforms.
  4. Apply sample preparation procedures to food samples for real-time PCR analyses.
 
Target Audience: This is an introductory course to real-time PCR theory, principals and applications. Nominees with little to no real-time PCR experience are encouraged to attend this course.
 
Prerequisite: 
  • Level I Analyst Certification.
  • Not previously attended the LB506 FDA/Food Emergency Response Network Real-Time PCR training course
 
Course Duration: 4.5 Days
CEU: 3.3
 
Course ID:            LB311
Course Title:         Principles and Laboratory Practices of Biosafety: BSL-2+ and BSL-3
 
Course Description:  This hands-on course for microbiologists introduces the biosafety principles and laboratory practices used in BSL-2+ and BSL-3 laboratories. Participants learn to: conduct risk assessments for all biosafety levels; prepare a variety of sample matrices; perform various sample techniques; conduct analytical manipulations within a biological safety cabinet; don and doff PPE appropriately.   
 
Course Objectives:
Upon completion of this course, participants will be able to:
1.      Demonstrate safe handling principles and practices used in BSL-2+ and BSL-3 laboratories
2.      Conduct risk assessment, including risk management and risk communication for all biosafety levels
3.      Prepare a variety of sample matrices in a BSL-2+ and BSL-3 laboratory environment
4.      Perform various sample techniques appropriate for use in the BSL-2+ and BSL-3 laboratory
 
Target Audience: FDA microbiologists
 
Prerequisites:  Before attending, nominees must have:
1.      Completed Level I Analyst Certification
2.      Respirator fit testing
 
Course Duration: 4.5 Days
CEU: 3.3
 
Course ID:            LB315
Course Title:         Virology
 
Course Description: This is a 5 day course containing didactic and laboratory instruction on foodborne virology and the molecular detection methods for enteric viruses. Specific lecture topics will include an overview of foodborne illness attributed to viruses, considerations for virus detection in foods, and molecular applications currently validated for use. Hands-on laboratory exercises encompassing viral isolation from selected food matrices; RNA extraction and reverse transcription; and, quantitative real-time PCR amplification and data assessment will be offered.
 
Target Audience: The course is primarily designed for FDA analysts that are currently participating in programs that currently screen for foodborne viruses.
 
Course Objectives:
Upon completion of this course, the participant will be able to:
  1. Outline how to safely handle and process virally contaminated foods.
  2. Identify the mechanism of viral transmission and their ability in causing food-borne related illnesses.
  3. Outline the principals and application of RT-qPCR for viral detection.
  4. Identify how to successfully extract and detect norovirus from raw, molluscan shellfish (clams, oysters).
  5. Identify how to successfully extract and detect hepatitis A virus from green onions using RT-qPCR.
 
Prerequisite: Prior to attending, nominees must have completed their Level I Analyst Certification.
 
  • Completed Level I Analyst Certification
  • Attended either the Fundamentals of Real-Time PCR (LB310) or FDA/Food Emergency Response Network Real-Time PCR (LB506) training course.
  • Not previously attended the LB504 FERN Virology training course
  • HAV vaccination or equivalent is recommended.
 
 
Course Duration: 4.5 Days
CEU: 3.3
 
Course ID:            LB316
Course Title:         Microanalytical
 
Course Description:   This course is review of the QA, Methods, Practices and Procedures used in Filth and Foreign or Extraneous Material analysis. It will include hands on training on current systematics and taxonomy. It will include a review of the reference materials and their application. It will include a review of the FD&C Act, DAL’s and filth guides, as well as the sampling procedures required to meet such guides. Case studies and exemplars will reinforce the principles and concepts taught in the lecture. It will include a session on FACTS reporting and help address FACTS FILTH problems and reporting needs. This is a dynamic learning experience designed to build upon the knowledge and experience of the participants. Optional management review/consensus sessions are offered in the evenings, but are not mandatory.
 
Course Objectives:
Upon completion of this course, the participant will be able to:
  1. Find the correct guide and method for various products.
  2. Determine the elements that can be used in court to support legal actions, including statutory provisions for adulteration and misbranding of food, drugs and cosmetics.
  3. Identify which guides might be applicable to different situations from both a theoretical and practical standpoint.
  4. Explain precedent decisions that have impacted, may impact, or will impact Agency actions. 
  5. Revised 1999 Filth Strategy. 
  6. Report accurately in FACTS and standardize Sample summaries.
  7. Train in specific techniques and review the chemistry of filth analysis and separationsDiscuss method validation and QA in FILTH analysis. Recognize the principles and objectives of laboratory QA/QC procedures and good laboratory practices as it applies to filth analysis.
  8. Discuss Reference and authentic material needs, consensus on how to satisfy Analyst needs.
 
Target Audience: Analysts using the principles of Filth and Foreign or Extraneous Material analysis and who are expected to utilize this training in their current position or in the near future.
 
Prerequisites: Prior to attending, nominees must have completed their New Hire training curriculum, including the audit (FDA: Level I)
 
Course Duration: 8 Days
CEU: Pending
 
Course ID:            LB401
Course Title:         Mobile Laboratory Training for Chemists
 
Course Description:  This hands-on course prepares participants for Mobile Laboratory deployments.  Participants learn to set-up and operate the GC/MS for Pesticide Analysis.
 
The purpose of this course is to introduce FDA chemists to operating practices, procedures and various technologies employed in the FDA Chemical Mobile Laboratory for screening analyses of various matrices for the presence of chemical contamination. Some of the compounds of interest include pesticides, toxic industrial compounds, and select agents. The technologies include Fourier transform infrared spectroscopy (FTIR), gas chromatography-mass spectrometry (GC/MS), and high performance liquid chromatography-ion trap mass spectrometry (LC/MS). FDA analysts will have some familiarity with the following systems:
  1. Agilent 6890/5973 GC-MS
  2. Agilent 1100 Capillary HPLC ThermoFinnigan / LCQ Deca XP Plus MS
  3. Radiation Detector
  4. SensIR-TravelIR FTIR
  5. Additionally, analysts will become familiar with special procedures for the protocols for deploying the mobile laboratory, sample handling, routine maintenance, troubleshooting, and emergency procedures. Finally, all of the fundamental practices necessary to operate this unique laboratory will be described: sample management (receiving, chain-of-custody, storage and disposal), chemical hygiene including waste disposal, supply and restocking and administration. 
 
Course Objectives:
Upon completion of this course, the participant will be able to:
  1. Set up, maintain, and shut down Mobile Laboratory units.
  2. Demonstrate proficiency in Mobile Laboratory safety procedures, analytical SOPs, and regulatory GLPs.
  3. Receive and report regulatory sample analysis into FACTS.
  4. Maintain inventory to keep the Mobile Laboratory at constant readiness.
  5. Perform appropriate analytical techniques for Pesticides.
 
Target Audience:  Level 1 Analyst Certified Chemists approved by their laboratory management to serve on the Mobile Laboratory Deployment Cadre (MLDC). 
 
Participant candidates must have the flexibility to work:
    • Outside normal working hours
    • As part of a team
    • In close quarters
    • Under stressful conditions
    • On future deployments
 
Prerequisites:  Prior to attending, nominees must have:
  • Management concurrence/commitment for participant to serve as a member of the Mobile Laboratory Deployment Cadre (per Mobile Laboratory MOU executed 12/9/04).
  • Level 1 Analyst Certification.
  • Successfully complete ICS 100 web module on Compliancewire.
  • Review Mobile Laboratory SOPs:
    • ORA-ML.001  Hazardous Waste Plan
    • ORA-ML.002  Chemical Hygiene Plan
    • ORA-ML.003  Chemical Management
    • ORA-ML.004  FDA Mobile Laboratory Driver
  • Proficiency with GC/MS.
 
COURSE COMPLETION REQUIREMENTS:  To successfully complete this course and receive a course certificate with Continuing Education Units* (CEUs), each participant will be required to:
  1. Successfully complete ICS 100 web module on Compliancewire prior to attending course.
  2. Be on time and attend the entire course
  3. Participate in class discussions, exercises, workshops and presentations
  4. Pass the course assessment(s)
 
Course Duration: 2.5 Days
CEU: Pending
 
Course ID:            LB402
Course Title:         Mobile Laboratory Training for Microbiologists
 
Course Description:
This hands-on course prepares participants for Mobile Laboratory deployments, including outbreaks and emergencies. Participants learn to set up and operate the rapid technologies used in the FDA Microbiological Mobile Laboratory such as QIAgility, AB7500, and automated DNA extraction (e.g., MagMax). Participants learn how to use the electronic analytical worksheet capture system (e431) and techniques to screen for pathogens such as Salmonella, EHEC, and Listeria using real-time PCR methods.
 
Target Audience:
Level I Analyst Certified Microbiologists approved by their laboratory management to serve on the Mobile Laboratory Deployment Cadre (MLDC)
 
Participant candidates must have the flexibility to work:
1.       outside normal working hours
2.       as part of a team
3.       in close quarters
4.       under stressful conditions
5.       on future deployments
 
Objectives:
After successfully completing the course participants will be able to:
  1. Perform appropriate analytical techniques for bacterial pathogens and interpret data in a Mobile Laboratory environment
  2. Set up, maintain, and shut down Mobile Laboratory units
  3. Demonstrate proficiency in Mobile Laboratory safety procedures, analytical SOPs, and regulatory Good Laboratory Practices
  4. Receive and report regulatory sample analysis with e431
  5. Maintain inventory to keep the Mobile Laboratory at constant readiness
 
 
Prerequisites:
  1. Management concurrence/commitment for participant to serve as a member of the Mobile Laboratory Deployment Cadre (per Mobile Laboratory MOU executed on 12/09/04)
  2. Level I Analyst Certification
  3. Successfully complete either the LB310 Real-Time PCR or LB506 FERN Real-Time PCR courses
  4. Review BAM chapters 4A, 5, and 10
  5. Proficient at confirmation of Salmonella, EHEC, and Listeria
  6. Successfully complete ICS 100 web module on Compliancewire
 
Course Duration: 5 Days
CEU: 3.8
 
Course ID:            LB403
Course Title:         Advanced Mass Spectrometry
 
Course Description: This is an advanced level course for analysts who are performing regulatory sample analysis using Mass Spectrometry techniques. The course will focus on both the theoretical aspects and practical applications of LC-MS and GC-MS in regulatory analyses through lectures and hands-on laboratory sessions. It will provide students with the knowledge, skills, abilities and techniques to enhance their analytical and problem solving skills in the area of MS.
 
 
Course Objectives:
Upon completion of this course, the participant will be able to:
1.       Apply knowledge of proper calibration methods for quantitation.
2.       Distinguish between different MS techniques.
3.       Demonstrate an understanding of ionization techniques and data interpretation.
4.       Apply data analysis techniques including use of library software.
5.       Outline emerging techniques in mass spectrometry.
 
Target Audience: Experienced Analysts currently utilizing LC-MS and/or GC-MS technology in their day-to-day activities as primary operators.
 
Prerequisites: Prior to attending, nominees must have completed the ORA New Hire training curriculum, including the audit (FDA: Level I).
 
Course Duration: 4.5 Days
CEU: 3.5
 
Course ID:            LB404
Course Title:         Advanced Elemental Analysis
 
Course Description: This is an advanced level course for analysts performing surveillance and regulatory analysis using elemental speciation techniques. The course will focus on specific methods and practical applications of HPLC-ICP-MS for arsenic speciation through lectures and hands-on laboratory sessions. The course will provide participants with the knowledge and skills to perform arsenic speciation analyses.
 
Course Objectives:
Upon completion of this course, the participant will be able to:
  1. 1Apply the basic principles and techniques of arsenic speciation including sample preparation, use of HPLC-ICP-MS instrumentation, and data analysis/evaluation for surveillance and regulatory analyses.
  2. Perform EAM Method 4.10 High Performance Liquid Chromatography-Inductively Coupled Plasma-Mass Spectrometric Determination of Four Arsenic Species in Fruit Juice.
  3. Perform EAM Method 4.11 Arsenic Speciation in Rice and Rice Products.
  4. Evaluate elemental speciation data and quality control elements.
 
Target Audience: Analysts with at least one (1) year of ICP-MS experience and who are expected to perform arsenic speciation.
 
Prerequisites:
1.       Level I Analyst Certification
2.       One (1) year of ICP-MS experience minimum.
3.       Experience with MassHunter software is required
 
Course Duration: 4.5 Days
CEU: 3.7
 
 
Course ID:            LB405
Course Title:         Advanced Real-Time PCR
 
Course Description: This course will be useful for analysts performing regulatory analyses on foodborne pathogens.
 
Course Objectives:
Upon completion of this course, the participant will be able to:
  1. 1Illustrate basic principles and applications of Real-Time PCR
  2. Apply sample processing procedures to food samples for detection of Vibrio species and EHEC for use with Real-Time PCR.
  3. Apply Real-Time PCR assay design and optimization for detection of foodborne pathogens.
  4. Apply Real-Time PCR techniques for other foodborne pathogens and viruses.
 
Target Audience: This course is targeted towards FDA regulatory microbiologists with a strong background in Real-Time PCR. Specifically whose responsibilities may include instrument maintenance, QA, providing in-house training and technical assistance to other analysts for Real-Time PCR.
 
Pre-requisites: Level I Analyst Certification. Must have successfully completed Fundamentals of Real-Tim PCR (LB310), FDA/FERN Emergency Response Network Real-Time PCR (LB506), training courses or equivalent experience (determined on a case by case basis).
 
 
Course Duration: 3.5 Days
CEU: Pending
 
Course ID:            LB406
Course Title:         Mobile Laboratory Training for Microbiologists Train-the-Trainer
 
Course Description:   The purpose of this course is to familiarize FDA analysts that have been working in the FDA Mobile Laboratory with the new instrumentation that has been incorporated. The course will provide hands-on experience with the new instruments and their software. The participants also receive an update on the e431 and how the new instruments will reflect changes to their analytical packages.
 
Course Objectives:
Upon completion of this course, the participant will be able to:
  1. Identify and practice special safety procedures appropriate to the Mobile Laboratories.
  2. Perform sample preparation using new instrumentation in Mobile Laboratory units.
  3. Appropriately document a sample, assess core required analyses and report results from analyses used in the Mobile Laboratory.
  4. Develop techniques to train other analysts during a deployment situation including instrument set-up/break-down and troubleshooting.
 
Target Audience: Microbiologists that have previously been on deployment or have been the Team Leader for a Mobile Laboratory Deployment. Participants hired after January 1, 2002 must be Level I Analyst Certified.
 
Prerequisites:
1.       Level I Analyst Certification
Must have previously participated in a Mobile Laboratory Deployment for Microbiology
 
Course Duration: 4.5 Days
CEU: 3.5
 
Course ID:            LB407
Course Title:         Mobile Laboratory Training for Drivers
 
Course Description:   This course covers the evolved and expanded mission-critical roles of drivers who move Mobile Laboratory Units. The course includes new step-by-step checklists for setting up and breaking down units, interacting with vendors, and troubleshooting solutions. Almost 90% of the course is hand-on. Course participants set up the Mobile Laboratory Units in real-time conditions, with vendors.
 
Course Objectives:
Upon completion of this course, the participant will be able to:
1.       Manage route planning and site configuration for individual deployments
2.       Coordinate with vendors at a deployment site for equipment set-up and pick-up
3.       Recognize issues, and contact appropriate people to solve problems
4.       Execute FDA Mobile Laboratory deployment check lists
 
Target Audience: Drivers with experience delivering, setting up, and/or breaking down Mobile Laboratory Units for deployments.
 
Pre-requisites
1.       Valid Driver’s License
2.       Commercial Driver’s License (for analytical and preparation unit drivers)
 
Course Duration: 3.5 Days
CEU: 2.5
 
Course ID:            LB501
Course Title:         FDA/Food Emergency Response Network - Screening Methodologies for the 
                                 Detection of Ba and Yp
 
Course Description: The course is designed to both acquaint and reinforce microbiologists with the commonly utilized classical microbiological techniques utilized in the analysis and identification of pathogenic bacteria. Microbial pathogens, and/or their toxins will be used in the course. Attenuated pathogens will be used in the course however; students should come prepared to work as if the organisms were fully virulent.
 
Course Objectives:
  1. Develop a working relationship between FERN laboratories involved in the detection of intentional contaminants in foods.
  2. Promoting the use of standard methodology for the detection of Bacillus anthracis and Yersinia pestis in food matrices.
 
Learning Objectives:
Students will take away from this course:
  1. Outline safe handling practices and list safety equipment and facility requirements.
  2. Illustrate various sample processing procedures used in the analysis of Bacillus anthracis and Yersinia pestis.
  3. Illustrate both enrichment and direct plating techniques for the detection of Bacillus anthracis and Yersinia pestis.
  4. Perform tests and interpret results for the presumptive identification of Bacillus anthracis and Yersinia pestis using cultural and rapid screens.
 
Target Audience: Federal, State and Local Public Health Microbiologists with appropriate laboratory facilities to run the food enrichment screening analysis of Bacillus anthracis and Yersinia pestis.
 
Prerequisites: Prior to attending, nominees must:
  1. Complete their Level I Analyst Certification.   
  2. Be from a registered FERN Microbiology Laboratory that possesses the capability of screening for Bacillus anthracis and Yersinia pestis.
  3. Have two years working experience as a Microbiologist at the BSL-2 level.
  4. Complete Respirator Fit Testing and receive approval for N-95 respirator prior to course attendance.
 
Course Duration: 4.5 Days
CEU: 3.4
 
Course ID:            LB503
Course Title:         FDA/Food Emergency Response Network Radiological Workshop for Uncertainty
 
Course Description: This workshop covers the development of General Uncertainty Models (GUM) to meet the specifications of ISO 17025 “General Requirements for the Competence of Testing and Calibration Laboratories” and the “Multi-Agency Radiological Laboratories Analytical Protocols Manual” (MARLAP manual). The terminology used in this workshop is consistent with NIST Technical Note 1297 “Guidelines for Evaluating and Expressing the Uncertainty of NIST Measurement Results”. In addition, the guidelines and processes for developing uncertainty estimates following the EURACHEM/CITAC “Guide: Quantifying Uncertainty in Analytical Measurement” will be introduced.
 
Course Objectives:
  1. Develop a working understanding of FDA/FERN requirements for developing the uncertainty of measurements;
  2. Acquire basic understanding of the concepts, terminology, and tools for developing and using uncertainty estimates; and
  3. Experience with evaluating and developing uncertainty estimates from processes and procedures common to radiochemical and chemical measurements.
 
Learning Objectives:
Students will take away from this course:
  1. Outline the basic information regarding the terms and concepts for expressing measurement uncertainty.
  2. Outline examples of uncertainty budgets forming a basis for more complete analyses.
  3. Apply the application of uncertainty in performance measurements and process improvements.
 
Target Audience: This workshop is for analysts from registered FERN Radiological Laboratories who participate in the FERN proficiency testing program.
 
Prerequisites: Attendees must be from a registered FERN Radiological Laboratory.
 
Course Duration: 3 Days
CEU: Pending
 
Course ID:            LB504
Course Title:         FDA/Food Emergency Response Network Virology
 
Course Description: This is a 5 day course containing didactic and laboratory instruction on foodborne virology and the molecular detection methods for enteric viruses. Specific lecture topics will include an overview of foodborne illness attributed to viruses, considerations for virus detection in foods, and molecular applications currently validated for use. Hands-on laboratory exercises encompassing viral isolation from selected food matrices; RNA extraction and reverse transcription; and, quantitative Real-Time PCR amplification and data assessment will be offered.
 
Course Objectives:
Upon completion of this course, the participant will be able to:
1.       Outline how to safely handle and process virally contaminated foods.
2.       Identify the mechanism of viral transmission and their ability in causing food-borne related illnesses.
3.       Outline the principals and application of RT-qPCR for viral detection.
4.       Identify how to successfully extract and detect norovirus from raw, molluscan shellfish (clams, oysters).
5.       Identify how to successfully extract and detect hepatitis A virus from green onions using RT-qPCR.
 
Target Audience: The course is primarily designed for analysts from FERN Microbiology laboratories that are currently screening for foodborne viruses.
 
Prerequisite:
Prior to attending, FDA nominees must:
1.       Completed their Level I Analyst Certification
2.       Attended either the Fundamentals of Real-Time PCR (LB310) or FERN Real-Time PCR (LB506) training course
3.       Have not previously attended the Virology (LB315) training course
 
Prior to attending, State and Local nominees must:
1.       Attended FDA/Food Emergency Response Network Real-Time PCR (LB506) training course or an equivalent type of Real-Time PCR training course.
 
Course Duration: 5 Days
CEU: 3.3
 
Course ID:            LB506
Course Title:         FDA/Food Emergency Response Network Real-Time PCR
 
Course Description: Upon completion of this course, students will be able to illustrate basic principles and applications of Real-Time PCR. The course is targeted towards FERN Microbiologists performing food analysis. The course focuses on Real-Time PCR instrument platforms and DNA extraction procedures currently used in FERN Microbiological Laboratories. Real-Time PCR Methods currently posted on the FERN eLEXNET website will be highlighted and include Salmonella and EHEC. This training course is equivalent to the FDA – Fundamentals of Real-Time PCR (LB310).
 
Course Objectives:
Upon completion of this course, students will be able to:
1.       Illustrate basic principles and applications of Real-Time PCR.
2.       Demonstrate good PCR practices and techniques.
3.       Apply real-time PCR techniques across multiple instrument platforms.
4.       Apply sample preparation procedures to food samples for Real-Time PCR analyses.
 
Target Audience: This is an introductory course to Real-Time PCR theory, principals and applications. Nominees with little to no Real-Time PCR experience are encouraged to attend this course.
 
Prerequisites:
1.       FERN Microbiologist from a registered FERN Microbiology Laboratory that possesses the capability to screen food samples using real-time PCR. 
2.       Not previously attended the LB310 Fundamentals of Real-Time PCR.
 
Course Duration: 4.5 Days
CEU: 3.2
 
Course ID:            LB508
Course Title:         FDA/Food Emergency Response Network Chemistry Training for Gas Chromatography – Mass Spectrometry (GC-MS)
 
Course Description:  Students will perform appropriate Food Emergency Response Network (FERN) analytical techniques for the assessment of chemical contamination in foods and interpret data in an international event. The course will introduce FERN Chemists to operating practices, procedures and various technologies employed in the FERN for screening and presumptive analyses of food matrices for the presence of chemical contamination. Some of the compounds of interest include pesticides, toxic industrial compounds, and poisons. The focus of this training course will be on the SOP No. FERN-CHE.0006.01 - FERN Drug and Poisons Screen using Acidic and Basic Extraction with GC-MS. Analysts should have some familiarity with Agilent 6890/5973 GC-MS.
 
Course Objectives:
Upon completion, participants will be able to:
 
  • Identify various sample handling and processing procedures that are appropriate for the analysis of foods in the context of the detection of gross levels of chemical contamination.
  • Prepare and analyze samples directly using the method, FERN-CHE.0006.01.
  • Employ suitable quality control elements to assure that the method is functioning properly.
  • Analyze and interpret data which is provided by the method and appreciate the limitations to this approach.
 
Target Audience: FERN Chemistry Laboratory Analysts from State, Local and Tribal FERN Laboratories with GC-MS capabilities.
 
Prerequisites: Prior to attending, nominees must:
1.       Be from a registered FERN Chemistry Laboratory which possesses the capability of screening foods for chemical contamination by GC-MS
2.       Have a minimum of one year working experience with GC-MS
 
Course Duration: 3 Days
CEU: 2.2
 
Course ID:            LB511
Course Title:         FDA/Food Emergency Response Network -- Chemistry Training for LC-Mass Spectrometry
 
 
Course Description: Students will perform appropriate Food Emergency Response Network (FERN) analytical techniques for the assessment of chemical contamination in foods and interpret data in an international event. The course will introduce FERN Chemists to operating practices, procedures and various technologies employed in the FERN for screening and presumptive analyses of food matrices for the presence of chemical contamination. Some of the compounds of interest include pesticides, toxic  industrial compounds and poisons. The focus of this training course will be on the FERN Liquid Chromatography-Mass Spectrometry (LC-MS) Method T022. Analysts should have some familiarity with the Agilent 1100 Capillary HPLC ThermoFinnigan / LCQ Deca XP Plus MS.
 
Course Objectives:
1.       Develop a working relationship between analysts from FERN laboratories involved in the detection of intentional contaminants in foods.
2.       Provide a detailed explanation of, and hands-on exposure to, standard methodology for the detection of chemical contamination in food matrices using LC-MS.
3.       Outline appropriate QA/QC procedures for the Thermo ion trap and Agilent 1100 HPLC instruments for which the method, T022 – Toxins/Poisons Screen using a Thermo ion trap MS with an Agilent 1100 HPLC, was developed.
4.       Illustrate various sample processing procedures and methods for sample handling that are appropriate for analysis of foods in the context of the detection of gross levels of chemical contamination.
5.       Perform the method for hands-on knowledge and its application for the detection of chemical contamination in foods.
6.       Analyze and interpret data generated through LC-MS instrumentation while understanding the limitations to the analysis.
 
Target Audience:  FERN Chemistry Laboratory Analysts from State, Local and Tribal FERN Laboratories with LC-MS capabilities.
 
Prerequisites: Registered FERN Chemistry laboratory
 
Course Duration: 3 Days
CEU: 1.4
 
Course ID:            LB512
Course Title:         FDA/Food Emergency Response Network -- Chemistry Training for Inductively Coupled Plasma-Mass Spectrometry (ICP-MS)
 
Course Description: The course will introduce operating principles and practices of elemental analysis based on the use of inductively coupled plasma mass spectrometry (ICP-MS). Through lectures and hands-on laboratory sessions, the course will focus on several methods for elemental analysis of foods using microwave digestion and ICP-MS, as well as, methods for arsenic speciation of fruit juice and rice products using high performance liquid chromatography (HPLC) coupled to ICP-MS. Participants will be provided with the knowledge and skills to enhance their analytical and problem solving skills in the area of elemental analysis and arsenic speciation using ICP-MS.        
 
Course Objectives:
Upon successful completion of the course, each student will be able to:
 
  1. Apply the basic principles and techniques of elemental analysis using ICP-MS including microwave digestion, ICP-MS instrumentation, and data analysis/evaluation for regulatory analyses.
  2. Apply the basic principles and techniques of arsenic speciation analysis including sample preparation, use of HPLC-ICP-MS instrumentation, and data analysis/evaluation for regulatory analyses.
  3. Be familiar with the following methods for the determination of toxic elements and arsenic speciation in foods:
       a) FCC Draft SOP T039 Determination of Trace Elements in Aqueous Solutions by ICP-MS
       b) Draft EAM Method 4.7 - ICP-MS Determination of Arsenic, Cadmium, Lead and Mercury in
         Food Using Microwave Assisted Digestion
       c) EAM Method 4.10 - HPLC-ICP-MS Determination of Four Arsenic Species in Fruit Juice
       d) Draft EAM Method 4.11 - Arsenic Speciation in Rice and Rice Products Using HPLC-ICP-
        MS Determination
  1. Interpret and evaluate data resulting from quantitative ICP-MS methods including quality control requirements.
  2. Interpret and evaluate arsenic speciation data from HPLC-ICP-MS methods including quality control requirements.
 
Prerequisites:
Prior to attending, nominees must:
  1. Have completed their new hire training curriculum, including the audit (FDA: Level I including the audit, or completion of 6 month district training program (includes 3 week new hire program) if hired prior to Jan 1, 2002 and not Level I; State: Basic Food Inspection Training Curriculum as referenced in Standard 2, Manufactured Food Regulatory Program Standards. State employees should have completed their new hire program and have experience working in the program area.
  2. Nominees must have a minimum of one year working experience with ICP-MS. It is preferable that nominees have experience with reaction/collision cell-based ICP-MS instruments.
 
Target Audience: FERN Chemistry Laboratory Analysts from State, Local, and Tribal FERN Laboratories with ICP-MS capabilities.
 
Course Duration: 4 Days
CEU: 2.8
 
Course ID:            LB515
Course Title:         FDA/Food Emergency Response Network -- Immunomagnetic Separation Techniques
 
Course Description: In this hands-on course, participants will utilize immunomagnetic separation (IMS) techniques for enhanced detection and isolation of foodborne pathogens. IMS utilizes antibody coated paramagnetic particles to selectively bind and concentrate the target organism. Captured cells are then tested using appropriate cultural or molecular methods. Participants will learn to use automated IMS systems including the Pathatrix and BeadRetreiver as well as manual IMS techniques. E. coli O157:H7 will be used as the target organism to demonstrate these techniques.
 
Course Objectives:
Upon completion of this course, the participant will be able to:
  1. Develop a working relationship between FERN laboratories involved in the detection of intentional and natural microbial contaminants in foods.
  2. Promote the use of standard methodologies for the detection of foodborne pathogens.
  3. Training Objectives:
  4. Demonstrate safe handling practices and use of safety equipment in a BSL-2 laboratory.
  5. Use automated immunomagnetic separation (IMS) instruments in the detection and isolation of pathogens in various foods.
  6. Conduct sample processing procedures and confirmatory tests using E. coli O157:H7 as a model for this technique.
  7. Produce and interpret results of analysis using IMS techniques in conjunction with rapid screening and cultural methods.
 
Target Audience:  FERN microbiologists with 2 years of experience working with pathogens in a BSL-2 laboratory.
 
Prerequisites:  FDA applicants must have completed Level I Analyst Certification.
 
Course Duration: 4.5 Days
CEU: 3.3
 
Course ID:            LB516
Course Title:         FDA/FERN Sample Preparation for Radiochemical Analyses  
                                 In Development
 
Course Description: This workshop presents guidelines for sample preparation methods for radiochemical analyses based on “Multi-Agency Radiological Laboratories Analytical Protocols Manual” (MARLAP manual) and CODEX STANDARD 193-1995 (amended 2010). The course will contain laboratory and lecture sessions.
 
Course Objectives:
Upon completion of this course, the participant will be able to:
1.       Develop a working understanding of requirements for the processing and preparation techniques required for radiochemical analyses
2.       Acquire basic understanding of the concepts, terminology, and processes for initial preparation and sub-sampling
 
Target Audience: This course is designed for radiochemists who prepare environmental and food samples for analysis.
 
Prerequisites: Prior to attending, nominees must:
1.       Participants must be from a registered FERN Radiological laboratory
 
Course Completion Requirements:
To successfully complete this course and receive a course certificate with Continuing Education Units* (CEUs), each participant will be required to:
1.       Be on time and attend the entire course
2.       Participate in class discussions, exercises, workshops and presentations
3.       Pass the course assessment(s)
 
Course Duration: Pending
CEU: Pending