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U.S. Department of Health and Human Services

Training and Continuing Education

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State Training Team Schedule - Manufactured Foods

State Training FY11 Classroom Schedule & Registration Contacts

 

 

MANUFACTURED FOODS

 

FD107  Egg Safety Inspection

FD150  Food GMPs 110

FD151  Food Inspection Techniques and Evidence Development

FD152  Food Processing and Technology

FD202  Acidified Foods

FD203  Conducting Low Acid Canned Food Inspections (formerly FD103)

FD219  Juice HACCP and Conducting Juice Inspections

FD249  Conducting Seafood Inspections(replaces video: Seafood HACCP for Regulators)

FD303  Advanced Low Acid Canned Food (LACF)

FD320  State Food Contract Auditing

FD340  Dietary Supplement Good Manufacturing Practices (GMP)     

FD405  Aseptic Processing for Food

 

 

 FD107 Egg Safety Inspection Training

 

The skills and knowledge obtained by the investigator during this course will provide the learner with the foundation of knowledge and skills to detect public health risks at egg laying facilities as described under 21 CFR Part118. The learner will be intimately involved in class room lecture, discussion and interactive activities designed to re-enforce learning and develop critical thinking skills required to conduct environmental and egg sampling, appropriately follow biosecurity and safety protocols commonly implemented during a farm investigation. Coursework includes a site visit to egg laying facility and exercises containing conditions that have been found on farms to develop the learner’s observation skills.

 

Course Goal:

 

Provide FDA inspectors with the foundation of knowledge and skills to implement new safety requirements as illustrated in 21 CFR Part 118 and detect the public health risk in egg production facilities on the farm.

 

Course Objectives:

 

By the end of the Egg Safety course the learner will have been presented with following key concepts that will enable the learner to effectively indentify, report, and document findings that support enforcement of applicable laws and regulations in 21 CFR Part 118:

 

  1. Definitions used in 21 CFR Part 118

 

  1. How to describe the intent of the Egg Safety Regulation

 

  1. Understand the content of Egg Safety Regulation 

 

  1. Know the appropriate Biosecurity procedures for performing an Inspection

 

  1. List required personal protective equipment (PPE) for conducting an egg inspection

 

  1. Demonstrate proper use of PPE in the field environment

 

  1. Indentify environmental conditions that may compromise safety during egg safety inspections

 

  1. Demonstrate appropriate sampling techniques

 

  1. Identify, document, and cite the observations during an egg safety inspection

 

Target Audience: This course is designed for FDA investigators and state inspectors who conduct investigations/inspections under the final egg rule 21 CFR Par 118, or under FDA contracts.

 

 

IMPORTANT: All investigators are required to have completed respirator training and fitted for either a half mask, full face mask or paper respirator.  Failure to provide a training certificate to your RTO will disqualify you for this course.  You will be required to bring your respirator with you to the course.

 

  • Investigators who own or have birds at their residence are prohibited from conducting investigations at poultry facilities.        
  • Bring comfortable clothing for the farm visit, conditions in TYVEC suites can get hot (you will most likely perspire), no open toed shoes.
  • The field trip activities in the laying houses can be strenuous and you can be subject to tight quarters, heights, getting dirty, and odors that will permeate your clothing.
  • If you have medical conditions or close proximity to live animals and manure cause you anxiety, talk to your supervisor before attending.
  • Commissioned Public Health Officers are authorized to wear comfortable civilian gear for the day of the farm visit per CAPT Diane Schaffer.  Uniform is to be worn for classroom lecture and exercises.

 

PREREQUISITES:

  • Completion of your new hire training curriculum

     FDA: Level I or 6 month district training program if hired prior to Jan 1, 2002 and not Level I

 

CEU: Pending                          Course Duration: 4 days                       Enrollment is limited to 40

 

Dates                Location                                               Registration Contact & FDA/ORA Trainer

 

10/26-29/10       Lancaster, PA                                        Bob Coger

 

11/16-19/10       Rancho Bernardo, CA                            Bob Coger

 

1/10 - 1/14         San Antonio, TX                                    Bob Coger

 

2/28 -3/4          Tampa, Fl                                                Bob Coger

 

3/29 - 4-1          Bar Harbor, ME                                       Bob Coger

 

4/15 -2/18         Seattle, WA                                            Bob Coger

 

TBD                  Ohio                                                      Bob Coger

 

TBD                  Des Moines, IA                                      Bob Coger

 

TBD                  Atlanta,  GA                                          Bob Coger

 

 

 

 

FD150 Food GMPs 110 (Core I)

                                                                                                                                                           

Course Description:  This course provides comprehensive coverage of the Good Manufacturing Practice (GMP) regulations, 21 CFR 110.  On completion of this course, students will have the skills and knowledge to identify food processing control deficiencies, food processing facility deficiencies, food processing plant plumbing deficiencies, sanitation deficiencies, and personnel related food safety deficiencies, to apply the appropriate sections of the GMP regulations in citing the observed food safety deficiencies, and to relate the GMP deficiency observation of an adulteration charge under the FD&C Act. The knowledge and skills investigators obtain through this course will provide a strong foundation in food safety inspections for manufactured foods.

 

Objectives:  Upon completion of Food Core I, participants will be able to:

·         Identify products regulated under 21 CFR 110

·         Identify 21 CFR 110 violations including but not limited to water system safety, equipment design and fabrication, food contact surface maintenance and sanitation, employee practices and health, pest control, and food processing controls.

·         Identify the food safety hazards created by 21 CFR 110 violations.

·         Evaluate and categorize filth based on the significance to public health.

 

Target Audience: FDA investigators, state inspectors, compliance officers, and supervisors who are actively engaged in the inspection of food manufacturing plants, or review or take compliance action on inspection reports. This course will become a prerequisite for advanced food courses and those seeking level II food certification.

 

Prerequisite: 

·         Completion of new hire training curriculum prior to attending

(FDA: Level I; State: Basic Food Inspection Training Curriculum as referenced in Standard 2, Manufactured Food Regulatory Program Standards)

·         Food Microbiology Control web course series, MIC 01-12 (States will have completed this web course series in their new hire training curriculum)

 

CEU Credits:  3.5          Course Duration: 5 days                                   Enrollment is limited to 50

 

 

 

Dates                            Location                         Registration Contact               FDA/ORA Trainer

 


The following State sponsored courses are open and available to Federal, State and local participants. These courses are offered as a non-consecutive series, i.e. FD150 and FD151 will not be held as back to back courses.  Please remember, when registering for a selected course, participants MUST attend the series in the States on the dates as indicated.

 

 

 

March 28-April 1,2011San Antonio, TX  Catherine Thibodaux
Catherine.Thibodaux@dshs.state.tx.us
512-834-6670
 Janet Williams
Janet.Williams@fda.hhs.gov
301-796-4534
    
    
    

 

March 28-April 1,2011    San Antonio, TX            Catherine Thibodaux                     Janet Williams

                                                              Catherine.Thibodaux@dshs.state.tx.us   Janet.Williams@fda.hhs.gov

                                                                        512-834-6670                             301-796-4534

 

Feb 14-18, 2011            Detroit or Lansing MI     Suzanne Kidder                          Janet Williams

                                                                        kidders@michigan.gov               Janet.Williams@fda.hhs.gov

269-721-8140                                                         301-796-4534

 

Jan 10-14, 2011 Madision, WI                             Tom Leitzke                               Janet Williams

                                                                        Tom.leitzke@datcp.state.wi.us   Janet.Williams@fda.hhs.gov

608-224-4711                                                         301-796-4534

 

Sept  12-16, 2011          Orlando, FL                   Aggie Hale                                Janet Williams

                                                                        halea@doacs.state.fl.us            Janet.Williams@fda.hhs.gov

850-245-5544                                                         301-796-4534

 

The courses listed below are given back to back with FD151: Both courses must be taken together:

 

 

Jan 31 – Feb 4, 2011     Orlando, FL                   Bob Coger                                Bob Coger

                                                                        Robert.Coger@fda.hhs.gov       Robert.Coger@fda.hhs.gov

                                                                        301- 796-8182                            301-796-8182

 

March 7 – 11, 2011        Albuquerque,NM           Bob Coger                                Bob Coger

                                                                        Robert.Coger@fda.hhs.gov       Robert.Coger@fda.hhs.gov

                                                                        301- 796-8182                            301-796-8182

 

April 4 – 8, 2011            San Antonio, TX            Jody Robinson                         Jody Robinson

                                                                        Jody.Robinson@fda.hhs.gov    Jody.Robinson@fda.hhs.gov

                                                                        301-796-4525                             301-796-4525

 

May 15 – 20, 2011         Chicago, I L                  Bob Coger                                Bob Coger

                                                                        Robert.Coger@fda.hhs.gov       Robert.Coger@fda.hhs.gov

                                                                        301- 796-8182                            301-796-8182

 

 

July 11- 15, 2011           Seattle, WA                   Jody Robinson                         Jody Robinson

                                                                        Jody.Robinson@fda.hhs.gov    Jody.Robinson@fda.hhs.gov

                                                                        301-796-4525                             301-796-4525

 

 

August 15-19, 2011        TBD                              Mary Fran Bodick                      Mary Fran Bodick

                                                                        mary.bodick@fda.hhs.gov         mary.bodick@fda.hhs.gov

                                                                        561-289-1191                             561-289-1191

 

 

FD151 Food Inspection Techniques and Evidence Development (Core II)

 

Course Description:  This course covers a review of FDA case work, inspection preparation and planning, case development strategies, aseptic sample collections, unit-by-unit examinations, microbiological inspections. There is intensive “hands-on” experience during class covering sampling, conducting reconciliation exams, and writing affidavits, FDA 483s, and EIRs. On completion of this course, the student will have the skills and knowledge to effectively complete a complicated domestic food safety assignment that will provide a strong foundation in food safety inspections for manufactured foods.

Objectives: Upon Completion of Food Core II, participants will be able to:

·         Identify common types of evidence used in food cases

·         Prepare a well constructed FD-483

·         Demonstrate ability to collect aseptic and micro samples

·         Document a unit by unit examination

·         Conduct reconciliation exam

 

Target Audience: FDA investigators, state inspectors, compliance officers, and supervisors who are actively engaged in the inspection of food manufacturing plants, or review or take compliance action on inspection reports. This course will become a prerequisite for advanced food courses and those seeking level II food certification.

 

Prerequisite: 

·         Completion of new hire training curriculum prior to attending

(FDA: Level I; State: Basic Food Inspection Training Curriculum as referenced in Standard 2, Manufactured Food Regulatory Program Standards)

·         Completion of Food GMPs FD150

 

CEU Credits:  3.0                      Course duration: 4 ½ days                   Enrollment is limited to 50

 

Dates                            Location                       Registration Contact                 FDA/ORA Trainer

 

The following State sponsored courses are open and available to Federal, State and local participants. These courses are offered as a non-consecutive series, i.e. FD150 and FD151 will not be held as back to back courses.  Please remember, when registering for a selected course, participants MUST attend the series in the States on the dates as indicated.

 

May 2-6, 2011               Michigan                       Suzanne Kidder                         Janet Williams

                                                                        kidders@michigan.gov              Janet.Williams@fda.hhs.gov

269-721-8140                                                         796-4534

 

 

May 16-20, 2011            San Antonio, Texas       Catherine Thibodaux                  Janet Williams

                                                            Catherine.Thibodaux@dshs.state.tx.us   Janet.Williams@fda.hhs.gov

                                                                        512-834-6670                             301-796-4534

 

The following courses are given back to back with the above FD150 courses:

 

Feb 7 – 11, 20111          Orlando, FL                   Bob Coger                                Bob Coger

                                                                        Robert.Coger@fda.hhs.gov       Robert.Coger@fda.hhs.gov

                                                                        301- 796-8182                            301-796-8182

 

March 14 – 18, 2011      Albuquerque,NM           Bob Coger                                Bob Coger

                                                                        Robert.Coger@fda.hhs.gov       Robert.Coger@fda.hhs.gov

                                                                        301- 796-8182                            301-796-8182

 

                                                                       

April 11 – 15, 2011         San Antonio, TX            Jody Robinson                         Jody Robinson

                                                                        Jody.Robinson@fda.hhs.gov    Jody.Robinson@fda.hhs.gov

                                                                        301-796-4525                             301-796-4525

 

May 23 – 27, 2011         Chicago, IL                   Bob Coger                                Bob Coger

                                                                        Robert.Coger@fda.hhs.gov       Robert.Coger@fda.hhs.gov

                                                                        301- 796-8182                            301-796-8182

 

 

July 18 – 22, 2011         Seattle, WA                   Jody Robinson                         Jody Robinson

                                                                        Jody.Robinson@fda.hhs.gov    Jody.Robinson@fda.hhs.gov

                                                                        301-796-4525                             301-796-4525

 

August 1 – 5, 2011        San Juan, PR                Mariely Ortiz Cruz                      Jody Robinson

                                                                        mortiz@salud.gov.pr                 Jody.Robinson@fda.hhs.gov

                                                                        (787) 765-2929 Ext. 3204 / 3214  301-796-4525

 

August 22-26, 2011        TBD                              Mary Fran Bodick                      Mary Fran Bodick

                                                                        Mary.bodick@fda.hhs.gov         mary.bodick@fda.hhs.gov

                                                                        561-289-1191                             561-289-1191

 

 

FD152  Food Processing and Technology (Core III)

 

Course Description:  This course provides an overview of the basic principles in food processing, technology, and associated equipment used to ensure the safety of manufactured foods.  Coursework includes detailed studies of food microbiology, food characteristics and properties, food chemistry, thermal processing and heat transfer, fluid flow, emerging technologies, preservation technologies, fillers and packaging technology.  Extensive “hands-on” experience with processing equipment is provided in a pilot laboratory setting.  The skills and knowledge obtained by Investigators through this course will provide a strong foundation in food safety inspections for manufactured foods.

 

Note: The “hands-on” experience requires access to processing equipment or pilot laboratory such as in a university setting. This includes the logistical support to demonstrate various different types of retorts, heat exchange systems, thermal processors, evaporators, dryers and evaporators, freezing equipment, extruders, homogenizers, pumps, and packaging equipment.

 

Objectives:  Upon completion of this course, participants will be able to:

·         Identify the factors and characteristics affecting the growth, control and destruction of microorganisms.

·         Describe the basic principles of heat transfer.

·         Describe the interaction of food, product formulation, and microorganisms as applied to food processing and packaging.

·         Identify the various types of processing equipment, instrumentation, and technology associated with food manufacturing, and their corresponding characteristics and problematic areas.

·         Describe the use and characteristics of emerging food processing technologies.

·         Identify the characteristics of packaging materials, including design, integrity, and protective properties for managing risks associated with processed foods.

 

Target Audience: FDA investigators, state inspectors, compliance officers, and supervisors who are actively engaged in the inspection of food manufacturing plants, or review or take compliance action on inspection reports. This course will become a prerequisite for advanced food courses and those seeking level II food certification.

 

Prerequisite:    Completion of new hire training curriculum prior to attending

(FDA: Level I; State: Basic Food Inspection Training Curriculum as referenced in Standard 2, Manufactured Food Regulatory Program Standards)

 

CEU Credits:  3.3                      Course duration: 4 ½ days                   Enrollment is limited to 35

 

 

Dates                Location                       Registration Contact                                 FDA/ORA Trainer                     

 

1/10-15/11         College Station, TX        Catherine Thibodaux                                     Lynn Hodges

                                                            Texas Dept. of State Health Svc                       

                                                            512-834-6670 ext. 2152                         

                                                            Catherine.Thibodaux@dshs.state.tx.us

 

3/14-18/11         West Lafayette, IN        

 

5/9-13/11           West Lafayette, IN        

 

6/6-10/11           West Lafayette, IN        

 

6/20-24/11         West Lafayette, IN        

 

7/18-22/11         West Lafayette, IN        

 

8/1-5/11            West Lafayette, IN        

 

8/8-12/11           West Lafayette, IN        

 

TBD                  Lexington, KY                 Mark Reed                                                    Lynn Hodges?

                                                              Kentucky Cabinet for Health & Family Svs         

                                                              502-564-7181                                                                                   
                                                            
Mark.reed@ky.gov

 

TBD                  TBD                                                                                         

 

 

 

 

FD202   Acidified Foods

 

Course Description: This intermediate to advanced course includes the following topics: acidified food microbiology, overview of 21 CFR Parts 108.25 and 114 Acidified Food Regulations, FDA registration and process filing, establishment of the acidification process, critical control points in the acidification process, documentation of process delivery, container integrity, and assistance to the small manufacturer.

 

Objectives: Upon completion of this course, participants will be able to:

·         Apply the principles and concepts of acidification processes to different food products

·         Identify an acidified food product

·         Identify buffering capacity of food products when dealing with acidification processes

·         Evaluate glass container closures and defects

·         Interpret the regulations (21 CFR 108, 114) to determine if the firm is processing an acidified food

 

Target Audience: FDA investigators, state inspectors, compliance officers, and supervisors who are actively engaged in acidified food inspections/import review or take compliance action on inspection reports.

 

Prerequisite:

·         Completion of new hire training curriculum prior to attending

(FDA: Level I; State: Basic Food Inspection Training Curriculum as referenced in Standard 2, Manufactured Food Regulatory Program Standards)

·         Completion of Foods GMPs 110 Course (FD150), Food Inspection Techniques and Evidence Development Course (FD151), and Food Processing and Technology Course (FD152); or have at least 2 years manufactured food inspection experience prior to attending.

·         Conducted at least one Acidified Food inspection of an Acidified food manufacturer (may be a training inspection) with someone who has completed Acidified Food training. Provide name of firm, FEI number and date they conducted the inspection.

·         FDA participants must have an active FACTS account.

·         Read the following documents prior to attending the course: 21 CFR Parts 108, 110, 113, and 114

 

CEU Credits: 3.4                       Course Duration: 4.5 days                                Enrollment is limited to 35

 

Dates                            Location                                               Registration Contact & FDA/ORA Trainer            

 

FY11

10/26-29/10                   San Diego, CA                                       Will Bet-Sayad  

                                                                                                301-796-4523

                                                                                                Will.Bet-Sayad@fda.hhs.gov

 

 

11/16-19/10                   Portland, OR                                         Will Bet-Sayad  

                                                                                                301-796-4523

                                                                                                Will.Bet-Sayad@fda.hhs.gov

 

3/1-4/11                        Battle Creek, MI                                     Suzanne Kidder

                                                                                                 616-813-9208

                                                                                                kidders@michigan.gov

 

Postponed to FY12       Albany, NY                                            Clarence Davis

 - State Request                                                                        518-457-4492 x2440

                                                                                                Clarence.davis@agmkt.state.ny.us

 

 3/28-4/1/11                   St. Paul, MN                                         Kristin Viger

                                                                                                651-239-9017

                                                                                                kristin.viger@state.mn.us          

 

 

 

 

FD203 Conducting Low Acid Canned Food Inspections (Previously Basic LACF FD103)

 

Course Description:  This course prepares FDA investigators and state inspectors to conduct inspections of low acid canned food manufacturing operations and warehouses.  Participants will enhance their ability to identify physical components of various retorts, evaluate processing records to recognize process deviations, identify significant food safety hazards and their controls, and apply LACF regulations. In addition to classroom lectures, the students will be required to participate in a series of group discussions, workshops and exercises designed to reinforce their understanding of the subject matter.  This course is a prerequisite for the Advanced Low Acid Canned Food Course (FD303).

 

Objectives: Upon completion of this course, participants will be able to:

·         Apply the principles, concepts of thermal processing, and the Low Acid Canned Food (LACF) regulations (21 CFR 113 and 108) to assigned inspections.

·         Identify critical equipment, required instrumentation, and problematic areas of various retorts as required in accordance with 21 CFR 113.

·         Conduct review of processing records and identify process deviations.

·         Evaluate packaging and packaging defects.

·         Identify objectionable conditions through observations and record review, and prepare a FDA 483 using appropriate Establishment Inspection Report (EIR) citations.  

 

Target Audience:  FDA investigators, state inspectors, compliance officers, and supervisors who are actively engaged in the inspection of LACF manufacturing facilities, or review or take compliance action on inspection reports. This course is a prerequisite for Advanced LACF FD303 and Aseptic Processing for Food FD405.

 

Prerequisite:

·         Completion of new hire training curriculum prior to attending

(FDA: Level I; State: Basic Food Inspection Training Curriculum as referenced in Standard 2, Manufactured Food Regulatory Program Standards)

·         Completion of Foods GMPs 110 Course (FD150), Food Inspection Techniques and Evidence Development Course (FD151), and Food Processing and Technology Course (FD152); or have at least 2 years manufactured food inspection experience prior to attending.

·         Food Microbiology Control web course series, MIC 01-12 (States will have completed this web course series in their new hire training curriculum)

·         FDA participants must have an active FACTS account.

·         Conducted at least one LACF inspection of a LACF manufacturer (may be a training inspection) with someone who has completed LACF training. Provide name of firm, FEI number and date they conducted the inspection.

·         Read the following documents prior to attending the course:

o        21 CFR Parts 108 and 113

o        FDA “Guide to Inspections of Low Acid Canned Food Manufacturers, Part 1 – Administrative Procedures” http://www.fda.gov/ICECI/Inspections/InspectionGuides/ucm074992.htm 

o        FDA “Guide to Inspections of Low Acid Canned Food Manufacturers, Part 2 – Processes/Procedures”  http://www.fda.gov/ICECI/Inspections/InspectionGuides/ucm074995.htm

o        FDA “Guide to Inspections of Low Acid Canned Food Manufacturers, Part 3 – Container/Closures”  http://www.fda.gov/ICECI/Inspections/InspectionGuides/ucm074999.htm

 

CEU Credits: 3.3           Course Duration:  4.5 days                   Enrollment is limited to 35

 

Dates                Location                       Registration Contact                 FDA/ORA Trainer

FY2011

 

12/6-10/10         Nashville, TN                 Erny Clausnitzer                          Erny Clausnitzer

                                                            813-215-5531                               813-215-5531

                                                            ernest.clausnitzer@fda.hhs.gov    ernest.clausnitzer@fda.hhs.gov

 

 

TBD                  TBD                              Jody Robinson                           Jody Robinson

                                                            Jody.Robinson@fda.hhs.gov       Jody.Robinson@fda.hhs.gov

                                                            301-796-4525                             301-796-4525

 

TBD                  TBD                              Jody Robinson                           Jody Robinson

                                                            Jody.Robinson@fda.hhs.gov       Jody.Robinson@fda.hhs.gov

                                                            301-796-4525                             301-796-4525

 

TBD                  TBD                              Jody Robinson                           Jody Robinson

                                                            Jody.Robinson@fda.hhs.gov       Jody.Robinson@fda.hhs.gov

                                                            301-796-4525                             301-796-4525

 

TBD                  TBD                              Jody Robinson                           Jody Robinson

                                                            Jody.Robinson@fda.hhs.gov       Jody.Robinson@fda.hhs.gov

                                                            301-796-4525                             301-796-4525

 

TBD                  TBD                              Jody Robinson                           Jody Robinson

                                                            Jody.Robinson@fda.hhs.gov       Jody.Robinson@fda.hhs.gov

                                                            301-796-4525                             301-796-4525

 

 

 

 

FD219 Juice HACCP and Conducting Juice Inspections (previously Juice HACCP)

 

Course Description:  Prepares FDA investigators and state inspectors to conduct Juice HACCP inspections. The course includes instruction on juice HACCP regulations, implementation of the juice HACCP regulations as applicable to juice processors, and the pre-requisite programs for juice HACCP (GMP’s, SSOP’s). Participants will enhance their ability to identify significant food safety hazards and their controls, perform their own hazard analysis, evaluate a juice HACCP plan or the controls in place in the absence of a plan, determine if the firm is implementing the plan and sanitation monitoring, document objectionable conditions, and apply the juice HACCP regulation – 21 CFR 120. In addition to classroom lectures, participants will be required to participate in a series of group discussions, exercises, and review of juice processes. This course complies fulfill training requirements established in the FDA Compliance Program Guidance Manual for those conducting domestic processor and importer juice HACCP inspections.

 

Objectives: Upon completion, participants will be able to:

 

1. Identify HACCP principles and their application to juice inspections;

 

2. Identify significant hazards and controls using the Juice HACCP Hazards and Controls Guidance;

 

3. Evaluate a juice hazard analysis and HACCP Plan, and determine if HACCP and sanitation monitoring programs are being implemented in accordance with 21 CFR 120;

 

4. Evaluate sanitation conditions in accordance with 21 CFR 110.

 

5. Identify and document violations through observations and record review, and collect evidence to support regulatory action; and against unsafe product in accordance with 21 CFR 120.

 

Target Audience: FDA investigators, state inspectors, supervisors, and compliance officers, responsible for conducting juice HACCP inspections, review, or take compliance action on inspection reports

.

Prerequisites:

Prior to attending, nominees must:

1. Complete new hire training curriculum prior to attending:

                        FDA: Level I

            State: Basic Food Inspection Training Curriculum as referenced in Standard 2, Manufactured Food Regulatory Program Standards

 

2. Complete Foods GMPs 110 Course (FD150), Food Inspection Techniques and Evidence Development Course (FD151), and Food Processing and Technology Course (FD152); or have at least 2 years manufactured food inspection experience prior to attending with supervisor’s concurrence.

 

3. Complete ORAU “Basics of HACCP” web course series FDA16, 17, and 18

 

4. FDA participants must have an active FACTS account

 

5. Conduct at least one juice HACCP inspection of a juice manufacturer (may be a training inspection) with someone who has completed the juice training. Provide name of firm, FEI number and date they conducted the inspection.

 

6. Read the following documents prior to attending the course:

            21 CFR 120

            FDA “Guidance for Industry, Juice HACCP Hazards and Controls Guidance, 1st Edition”

 

http://www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/GuidanceDocuments/Juice/u cm072557.htm

c. Juice HACCP Alliance “Juice HACCP Training Curriculum, First Edition”

http://www.iit.edu/ncfst/graduate_degrees_and_courses/graduatedegrees_juicehaccptraining.shtml

 

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)

 

CEU Credits:  3.4                                  Course Duration:  4.5 days                   Enrollment is limited to 40

 

 

Dates                            Location                       Registration Contact                             FDA/ORA Trainer                     

01/ 24-28/2011               Albany, NY                   Clarence Davis                                       Mary Fran Bodick

                                                                        518 457 4492                                         561 289 1191

                                                                        clarence.davis@agmkt.state.ny.us          mary.bodick@fda.hhs.gov

 

03/14-18/2011                San Diego, CA              Mary Fran Bodick                                  Mary Fran Bodick         

                                                                        561 289 1191                                         561 289 1191

                                                                        mary.bodick@fda.hhs.gov                      mary.bodick@fda.hhs.gov

 

 

05/16-20/2011                Austin, TX                     Mary Fran Bodick                                  Mary Fran Bodick         

                                                                        561 289 1191                                         561 289 1191

                                                                        mary.bodick@fda.hhs.gov                     mary.bodick@fda.hhs.gov

 

07/25-29/2011                Chicago, IL                   Mary Fran Bodick                                  Mary Fran Bodick                                                                         
                                                                       
561 289 1191                                         561 289 1191

                                                                        mary.bodick@fda.hhs.gov                     mary.bodick@fda.hhs.gov

 

 


 

 

 

FD249 Conducting Seafood Inspections

 

(Replaces Seafood HACCP for Regulators Video series)

 

Course Description: provides the basic components of conducting a Seafood HACCP inspection that would likely result in an acceptable inspection.  Participants will enhance their ability to identify significant food safety hazards and their controls, perform their own hazard analysis, evaluate a HACCP plan or the controls in place in the absence of a plan, determine if the firm is implementing the plan and sanitation monitoring, collect evidence and document objectionable conditions in order to take action against unsafe product. 

 

This course was converted and updated from the video series: Seafood HACCP Regulator Training Course, Encore Seafood Training and the Seafood HACCP Regulators Training Program (The Sequel) and also includes the updated Seafood Hazards Guide.

 

Objectives: Upon completion of this course, participants will be able to:

·            Identify and apply the components of a HACCP and cGMP

·            Identify significant hazards and their controls using the Fish and Fishery Products Hazards and Controls Guidance Manual

·            Determine if HACCP and sanitation monitoring programs are being implemented and in the absence of a plan or monitoring if controls are in place

·            Evaluate sanitary conditions

·            Document violations through observation and record review and to collect evidence to take regulatory action against unsafe product.

 

Target Audience: FDA investigators, state inspectors, compliance officers, and supervisors who are actively engaged in seafood processor inspections, or review or take compliance action on inspection reports.

 

Note: Investigators/inspectors must have successfully completed this course and prerequisites before conducting seafood inspections per the compliance program: 7303.842 Domestic Fish and Fishery Products Inspection Program http://inside.fda.gov:9003/downloads/ProgramsInitiatives/Food/FieldPrograms/ucm018830.pdf#inspect  Those conducting import verification operations also need to meet these requirements per the Import Seafood Products Compliance Program

http://inside.fda.gov:9003/downloads/ProgramsInitiatives/Food/FieldPrograms/ucm019004.pdf

 

Prerequisite:  Prior to attending, nominees must:

·         Completion of new hire training curriculum prior to attending

(FDA: Level I; State: Basic Food Inspection Training Curriculum as referenced in Standard 2, Manufactured Food Regulatory Program Standards)

·         Completion of Foods GMPs 110 Course (FD150), Food Inspection Techniques and Evidence Development Course (FD151), and Food Processing and Technology Course (FD152); or have at least 2 years manufactured food inspection experience prior to attending.

·         Food Microbiology Control web course series, MIC 01-12 (States will have completed this web course series in their new hire training curriculum)

Must have completed the 3 day AFDO Basic Seafood HACCP Alliance Course or the on-line course (Segment 1) and 1 day face-to-face (Segment 2). (See AFDO’s website for information on course locations and registration http://www.afdo.org/afdo/HACCP/seafood.cfm or http://seafood.ucdavis.edu/events.html#section2 )

·         Participate on a minimum of two joint Seafood HACCP inspections with someone who has completed the training prior to attending the course.

 

CEU Credits: 2.3                       Course Duration: 4 ½  days                  Enrollment is limited to 40

Dates                            Location                       Registration Contact               FDA/ORA Trainer

10/18-22/10                   Rockville, MD (DHRD)     Nancy Doyle                             Nancy Doyle

                                                                        503-671-9711-14                        503-671-9711-14

                                                                        Nancy.Doyle@fda.hhs.gov         Nancy.Doyle@fda.hhs.gov

 

01/10-14/11                   Orlando, FL                   Nancy Doyle                              Nancy Doyle

                                                                        503-671-9711-14                        503-671-9711-14

                                                                        Nancy.Doyle@fda.hhs.gov         Nancy.Doyle@fda.hhs.gov

 

02/7-11/11                     San Antonio, TX                        Nancy Doyle                 Nancy Doyle

                                                                        503-671-9711-14                       503-671-9711-14

                                                                        Nancy.Doyle@fda.hhs.gov         Nancy.Doyle@fda.hhs.gov

 

02/28-03/04                   Detroit, MI                     Nancy Doyle                             Nancy Doyle

                                                                        503-671-9711-14                       503-671-9711-14

                                                                        Nancy.Doyle@fda.hhs.gov         Nancy.Doyle@fda.hhs.gov

 

04/4-8/11                       Portland, OR                 Nancy Doyle                             Nancy Doyle

                                                                        503-671-9711-14                       503-671-9711-14

                                                                        Nancy.Doyle@fda.hhs.gov         Nancy.Doyle@fda.hhs.gov

 

07/11-15/11                   Albany, NY                   Nancy Doyle                             Nancy Doyle

                                                                        503-671-9711-14                       503-671-9711-14

                                                                        Nancy.Doyle@fda.hhs.gov         Nancy.Doyle@fda.hhs.gov

 

 

FD303 Advanced Low Acid Canned Food

 

Course Description:  This course focuses on the principles and concepts of LACF thermal process establishment, temperature distribution, process documentation, advanced retort systems and container technology.  Instruction on conducting intensive inspections of canning operations for compliance with the Food, Drug and Cosmetic Act, 21 CFR 108, 113 and 114 and other applicable regulations.  In addition to classroom lectures, the students will be required to participate in a series of workshops and exercises designed to reinforce their understanding of the subject matter. 

 

Objectives:  Upon completion of this course, participants will be able to:

·         Apply the principles and concepts of thermal processing to assigned inspections both foreign and domestic

·         Determine process deviations during record review

·         Calculate thermal processing values for retort processing

·         Evaluate metal can seams, glass container closures and flexible packaging defects

 

Target Audience: FDA investigators, state Inspectors, supervisors, and compliance officers, responsible for conducting complex LACF inspections or review or take compliance action on complex LACF inspection reports.

 

Prerequisites: 

·         Completion of new hire training curriculum prior to attending

(FDA: Level I; State: Basic Food Inspection Training Curriculum as referenced in Standard 2, Manufactured Food Regulatory Program Standards)

·         Completion of Foods GMPs 110 Course (FD150), Food Inspection Techniques and Evidence Development Course (FD151), and Food Processing and Technology Course (FD152); or have at least 2 years manufactured food inspection experience prior to attending.

·         Conducting Low Acid Canned Food Inspections FD203.

 

CEU Credits:  Pending                          Course duration: 2 weeks                     Enrollment is limited to 30

 

Dates                Locations                                             Registration Contact & FDA/ORA Trainer

                       

TBD                  TBD                                                                  Jody Robinson

                                                                                                Jody.Robinson@fda.hhs.gov

                                                                                                301-796-4525

 

TBD                  TBD                                                                  Jody Robinson

                                                                                                Jody.Robinson@fda.hhs.gov

                                                                                                301-796-4525

 

 

FD320 State Food Contract Auditing

 

 

Course Description:  This course will provide background information and a historical perspective of the state contract auditing process.  Classes will include lectures and exercises that introduce draft audits forms, as well as, instructions on how to prepare for and conduct audits. 

 

Objectives:  At the conclusion of this course, attendees will be able to:

·         Identify the procedures that are followed to conduct audits of State inspectors, who conduct inspections under FDA’s food contract

·         Apply the audit principles to identify and assess issues encountered during the State contract inspections

·         Identify the responsibilities and roles of both the auditor and the auditee

 

Target Audience:  FDA co-project officers, Consumer Safety Officers (i.e. investigators), and/or state personnel who will have the lead in auditing state inspectors and/or the program under state food inspection contracts. Courses are scheduled by their primary audience as related to the audit: state personnel or FDA personnel.

 

Prerequisite:

·         Completion of new hire training curriculum prior to attending

(FDA: Level I; State: Basic Food Inspection Training Curriculum as referenced in Standard 2, Manufactured Food Regulatory Program Standards)

·         Previous experience conducting independent manufactured food inspections

 

CEU Credits:   Pending                         Course duration: 1 ½ days         Enrollment is limited to 30

 

Dates                            Location                                               Registration Contact & FDA/ORA Trainer

 

07/13-14/11                   Nashville, TN                                         Deena D’Addario

                                                                                                301-796-4538

                                                                                                Deena.DAddario@fda.hhs.gov

 

 

 

 

FD340  Dietary Supplement Good Manufacturing Practices (GMP)

 

 

Course Description:  This course is designed to prepare investigators to conduct inspections of dietary supplement manufacturing and packaging operations.  The course will focus on current Good Manufacturing Practices (GMP) for manufacturers including personnel, control of facilities, laboratory, quality control, product content and labeling, and other requirements of the GMP regulations.  The course content will include lectures, exercises, group discussions, and review of  dietary supplement products.

 

Objectives:  Upon completion of the course, participants will be able to:

·         Recognize the requirements of the Dietary Supplement cGMP regulations

·         Identify violations of the regulations that may require regulatory action

·         Recommend corrective actions necessary to comply with the cGMP regulations

 

Target Audience:  Participants will be limited to those field investigators who are actively engaged in the inspection/investigation of dietary supplement manufacturing, supervisors of staff conducting these inspections, or compliance officers who will be actively reviewing cases.

 

Prerequisites:  Prior to attending the training course, each course participant must carefully review:

·         the published regulations, including the preamble, for Dietary Supplement GMP, available at:

 

http://www.cfsan.fda.gov/~lrd/fr07625a.html

 

·         the webcast archive of the October 24, 2007 satellite broadcast entitled,  “Overview of the Implementation of the Current Good Manufacturing Practices for Dietary Supplements Guidance for Industry,” available at:

 

http://fda.yorkmedia.com/fda/Catalog/Front.aspx?cid=4b6163c8-e9ec-4b54-b6ae-6560c1c86fda

 

 

 

CEU credits:  Pending               Course Duration: 4 ½ days                   Enrollment: Limited to 40

 

Dates                            Location                                   Registration Contact & FDA/ORA Trainer

 

05/17-20/11                   Memphis, TN                               Allen Gelfius

                                                                                      Allen.Gelfius@fda.hhs.gov

                                                                                      301-796-4517

                                   

 

FD405 Aseptic Processing for Food

 

 

Course Description:  This course focuses on the principles and concepts of aseptic thermal processes. This course will cover the advanced technology and techniques involved with aseptic systems and will focus on the thermal process establishment, temperature distribution, process documentation, advanced aseptic systems and container technology.  Instruction on conducting intensive inspections of aseptic canning operations for compliance with the Food, Drug and Cosmetic Act, 21 CFR 108, 113 and 114 and other applicable regulations.  In addition to classroom lectures, the students will be required to participate in a series of workshops and exercises designed to reinforce their understanding of the subject mater.

 

Objectives:  Upon completion of this course, participants will be able to:

·         Apply the principles and concepts of aseptic thermal processing to assigned inspections both foreign and domestic

·         Determine process deviations during record review

·         Calculate thermal processing values for aseptic retort processing

·         Evaluate aseptic processing equipment

 

Target Audience: FDA investigators, state inspectors, compliance officers, and supervisors who are actively engaged in inspections of  aseptic food firms or review or take compliance action on these inspection reports pertaining to LACF regulations, Parts 108, 113 and 114.

 

Prerequisites: 

·         Completion of new hire training curriculum prior to attending

(FDA: Level I; State: Basic Food Inspection Training Curriculum as referenced in Standard 2, Manufactured Food Regulatory Program Standards)

·         Completion of Foods GMPs 110 Course (FD150), Food Inspection Techniques and Evidence Development Course (FD151), and Food Processing and Technology Course (FD152); or have at least 2 years manufactured food inspection experience prior to attending.

·         Completion of the Food Microbiology web course series, MIC 01-12 (States will have completed this web course series as part of their new hire training curriculum)

·         Conducting Low Acid Canned Food Inspections FD203

·         Advanced Low Acid Canned Foods FD303

·         Must have participated in at least one joint aseptic processing inspection.

 

CEU Credits: 3.5           Course duration:  4 ½ days                              Enrollment is limited to 30

 

Dates                Location                       Registration Contact                 FDA/ORA Trainer                     

 

TBA                  TBA                              Jody Robinson                           Jody Robinson

                                                            Jody.Robinson@fda.hhs.gov        Jody.Robinson@fda.hhs.gov

                                                            301-796-4525                             301-796-4525