Manufactured Foods FY2009

ORAU State Training Classroom Course Schedule 
FY09 & FY10
MANUFACTURED FOODS

FD103 - Conducting Low Acid Canned Food Inspections (previously Basic LACF)

Course Description:  This course prepares FDA investigators to conduct Low Acid Canned Food inspections in their district. The course provides information on the LACF regulations and their interpretation. 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, 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 1113.
  • 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:  This course is being offered to field investigators, compliance officers and state investigators who are actively engaged in the inspection of LACF manufacturing facilities, and supervisors whose staff conducts LACF inspections.  This course will be a prerequisite for all advanced LACF and Acidified Food (AF) courses.

• • Prerequisite: N/A
  • Post assessment:  student must complete an LACF inspection within 90 days after course completion
  • CEU Credits:  3.3
  • Course Duration: 4 ½ days

Dates	Location	Registration Contact	FDA/ORA Trainer
06/08-12/09	Atlanta, GA		Timothy Weigner 301-796-4536 Timothy.Weigner@fda.hhs.gov
08/10-14/09	Denver, CO		Timothy Weigner 301-796-4536 Timothy.Weigner@fda.hhs.gov

 

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FD150 - Food GMPs 110 (New course, offered consecutively with FD151)

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 result in an increased protection of the public health.

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: Those that inspect food manufacturing plants or review or take action on these inspection reports such as investigators, supervisors, or compliance officers.  This course will be a prerequisite for all advanced food courses will be required for those seeking level II food certification.

• • Prerequisite:  Completion of New Hire Training prior to attending.
  • CEU Credits:  3.5
  • Course Duration: 5 days
  • Enrollment is limited to 25

Dates	Location	Registration Contact	FDA/ORA Trainer
02/02-06/09	Rockville, MD		Jody Robinson 301-796-4525 Jody.Robinson@fda.hhs.gov
03/23-27/09	Rockville, MD		Jody Robinson 301-796-4525 Jody.Robinson@fda.hhs.gov
04/20-24/09	Rockville, MD		Jody Robinson 301-796-4525 Jody.Robinson@fda.hhs.gov
06/15-19/09	Newport Beach, CA		Jody Robinson 301-796-4525 Jody.Robinson@fda.hhs.gov
07/27-08/01/09	Minneapolis, MN		Jody Robinson 301-796-4525 Jody.Robinson@fda.hhs.gov

 

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FD151 - Food Inspection Techniques and Evidence Development (New Course offered consecutively with FD150)

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 result in increased protection of the public health.

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: Those that inspect food manufacturing plants or review or take action on these inspection reports such as investigators, analysts, supervisors, or compliance officers.  This course will be a prerequisite for all advanced food courses will be required for those seeking level II food certification.

• • Prerequisite:  Completion of New Hire Training prior to attending.
  • CEU Credits:  3.3
  • Course duration: 4 ½ days
  • Enrollment is limited to 25

Dates	Location	Registration Contact	FDA/ORA Trainer
02/09-13/09	Rockville, MD		Jody Robinson 301-796-4525 Jody.Robinson@fda.hhs.gov
03/30-04/03/09	Rockville, MD		Jody Robinson 301-796-4525 Jody.Robinson@fda.hhs.gov
04/27-05/01/09	Rockville, MD		Jody Robinson 301-796-4525 Jody.Robinson@fda.hhs.gov
06/22-26/09	Newport Beach, CA		Jody Robinson 301-796-4525 Jody.Robinson@fda.hhs.gov
08/03-07/09	Minneapolis, MN		Jody Robinson 301-796-4525 Jody.Robinson@fda.hhs.gov

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FD152  Food Processing and Technology (NEW)

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 result in an increased protection of the public health.

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: Those that inspect food manufacturing plants or review or take action on these inspection reports such as investigators, analysts, supervisors, or compliance officers.  This course will be a prerequisite for all advanced food courses will be required for those seeking level II food certification.

• • CEU Credits:  Pending
  • Course duration: 4 ½ days
  • Enrollment is limited to 25

Dates	Location	Registration Contact	FDA/ORA Trainer
03/16-20/09	West Lafayette, IN		Timothy Weigner 301-796-4536 Timothy.Weigner@fda.hhs.gov
05/04-08/09	West Lafayette, IN		Timothy Weigner 301-796-4536 Timothy.Weigner@fda.hhs.gov
006/01-05/09	West Lafayette, IN		Timothy Weigner 301-796-4536 Timothy.Weigner@fda.hhs.gov
07/13-17/09	West Lafayette, IN		Timothy Weigner 301-796-4536 Timothy.Weigner@fda.hhs.gov
08/03-07/09	West Lafayette, IN		Timothy Weigner 301-796-4536 Timothy.Weigner@fda.hhs.gov

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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: Sanitarians, investigators, inspectors, extension agents and other regulators involved in inspecting or advising the acidified food industry.

• • Prerequisite: N/A
  • CEU Credits: 1.8
  • Course Duration: 3 days
  • Enrollment is limited to 40

Dates	Location	Registration Contact	FDA/ORA Trainer
08/25-27/09	Rockville, MD		Will Bet-Sayad 301-796-4523 Will.Bet-Sayad@fda.hhs.gov

 

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FD249 - Conducting Seafood Inspections (NEW) (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:  Those that inspect seafood processors or review or take action on these inspection reports such as FDA or state investigators, supervisors, or compliance officers. 

• • Prerequisite:FD248 Seafood HACCP Alliance Training Program
  • CEU Credits:  2.6
  • Course Duration:  3 ½  days

Dates	Location	Registration Contact	FDA/ORA Trainer
12/16-19/08	Rockville, MD		Jody Robinson 301-796-4525 Jody.Robinson@fda.hhs.gov
01/27-30/09	Orlando, FL		Jody Robinson 301-796-4525 Jody.Robinson@fda.hhs.gov
03/10-13/09	Seattle, WA		Jody Robinson 301-796-4525 Jody.Robinson@fda.hhs.gov
05/05-08/09	San Antonio, TX		Jody Robinson 301-796-4525 Jody.Robinson@fda.hhs.gov
07/21-24/09	Boston, MA		Jody Robinson 301-796-4525 Jody.Robinson@fda.hhs.gov

 

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Dates	Location	Registration Contact	FDA/ORA Trainer
TBD	Chicago, IL		Timothy Weigner 301-796-4536 Timothy.Weigner@fda.hhs.gov

 

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Dates	Location	Registration Contact	FDA/ORA Trainer
02/03-06/09	Raleigh, NC	Larry Gabriel 919-733-7366 Larry.Gabriel@ncagr.gov	Timothy Weigner 301-796-4536 Timothy.Weigner@fda.hhs.gov
05/19-22/09	Newport Beach, CA		Timothy Weigner 301-796-4536 Timothy.Weigner@fda.hhs.gov
06/02-05/09	San Juan, PR	Mariely Ortiz Cruz Puerto Rico Department of Health Environmental Health Secretariat San Juan, PR  00936-8184 mortiz@salud.gov.pr	Jody Robinson 301-796-4525 Jody.Robinson@fda.hhs.gov
07/06-10/09	Northhampton, MA	Beth Altman MA Dept. of Public Health 308 South St. Jamaica Plain, MA  02130 617-983-6769 Beth.Altman@state.ma.us	Will Bet-Sayad 301-796-4523 Will.Bet-Sayad@fda.hhs.gov
08/25-28/09	Albany, NY	Ernest Clausnitzer 813-228-2671 x22 Ernest.Clausnitzer@fda.hhs.gov	Ernest Clausnitzer 813-228-2671 x22 Ernest.Clausnitzer@fda.hhs.gov

 

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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:  Federal and state regulatory officials who are involved in the audits of state contracts and who have had experience in either oversight or joint inspection with state contractors.

• • Prerequisite: N/A
  • CEU Credits:  2.0
  • Course duration: 2 ½ days
  • Enrollment is limited to 40

 

Dates	Location	Registration Contact	FDA/ORA Trainer
01/20-21/09	Albuquerque, NM	Larry Gabriel 919-733-7366 Larry.Gabriel@ncagr.gov	Deena.D’Addario 301-796-4538 Deena.Daddario@fda.hhs.gov
03/31-04/01/09	Atlanta, GA		Deena.D’Addario 301-796-4538 Deena.Daddario@fda.hhs.gov

 

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FD340  Dietary Supplements (NEW course)

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

Objectives:  Upon completion of the course, participants should 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 of dietary supplement manufacturing, supervisors whose staff conduct these inspections, or compliance officers who will be actively reviewing cases.

Prerequisites:  Participants must read and be familiar with the Dietary Supplement cGMP regulations including the preamble and background, which will be provided to participants prior to attending the course.

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

Dates	Location	Registration Contact	FDA/ORA Trainer
03/24-27/09	Memphis, TN	Larry Gabriel 919-733-7366 Larry.Gabriel@ncagr.gov	Allen Gelfius 301-796-4517 Allen.Gelfius@fda.hhs.gov
05/18-22/09	Memphis, TN		Allen Gelfius 301-796-4517 Allen.Gelfius@fda.hhs.gov
06/22-26/09	Memphis, TN		Allen Gelfius 301-796-4517 Allen.Gelfius@fda.hhs.gov

 

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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 involve4d with an aseptic system.  It 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:

Target Audience:  This is an advanced course designed to enhance the knowledge of investigators/laboratory analysts, compliance officers who have an understanding and working knowledge of the FDA LACF regulationns, Parts 108, 113 and 114.

Prerequisite: 

 

Not currently being offered in FY09

 

 

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