The target audience is new members of the risk analysis community. It provides a generic overview of risk analysis. It serves as a contextual primer for anyone interested in or involved with a broad range of risk analysis activities, regardless of application.

Prerequisites: None

Overview of Topics

Introduction to Risk Management, Risk Assessment, and Risk Communication terms, concepts and uses.

Learning Objectives

• Language of risk analysis
• Risk Management Decision-Making Principles
• How risk analysis fits into the WTO
• General principles of food/public health law
• Understanding how risk analysis fits into the US Food Safety /Legal System

This course meets a requirement of the JIFSAN Core Certificate in Food Safety Risk Analysis

Risk Management is the process of weighing policy alternatives to control risks as effectively as possible. Success in risk management means arriving at practical and useful solutions to problems that can be plagued by uncertainty and variability. Risk managers are the decision makers and begin and end all risk analysis activities, they are responsible for the risk analysis process.

This 2-day in classroom course is about getting to the final decision. It is designed not just for decision makers but also for all those who will work with decision makers.

Prerequisite:While not required, it is recommended that this course be taken after you have completed the Introduction to Risk Analysis and the Regulatory Process. That course provides contextual information about risk analysis that is not repeated here.

Overview of Topics

Introduction to Risk Management paradigms, models, evaluating options, and interacting with risk assessor’s terms, concepts and uses.

Learning Objectives

• Paradigms and How We Think About Things
• Risk Management Frameworks and Models
• Getting the Question Right
• Making Sense of Numbers
• Risk Management Options
• Interactions Between Assessors and Managers

This course meets a requirement of the JIFSAN Core Certificate in Food Safety Risk Analysis

The Qualitative Risk Assessments course focuses on the skills needed to predict the likelihood of harm resulting from exposure to chemical, microbial and physical agents in the diet.
Our 2-day in classroom course introduces the range of risk assessment approaches across a wide spectrum of food safety hazards, providing hands-on experience with both qualitative and quantitative techniques.

Prequisite:While not required, it is recommended that this course be taken after you have completed the Introduction to Risk Analysis and the Regulatory Process and the Risk Management course. Those two courses provide contextual information about risk analysis that is not repeated here.

It is strongly recommended that this course be taken after you have completed the Risk Management course. The Risk Management course provides contextual information about risk analysis that is not repeated here.

Overview of Topics

Context of Food Safety Risk Assessment, The Risk Assessor's Toolbox, Applications, and Components>

Learning Objectives

• Fundamental reasons for risk analysis
• Key developments in the role of risk assessment in international food safety
• Demonstrate familiarity with the wide range of formal definitions of risk assessment
• Differentiate variability and uncertainty in risk assessment
• Significance of uncertainty and variability to the Risk Assessor and Risk Manager
• Discuss the role of probability in quantitative risk assessment
• Identify several of the more frequently used probability distributions in risk assessment
• Understanding the differences between chemical and microbial risk assessment

This course meets a requirement of the JIFSAN Core Certificate in Food Safety Risk Analysis

The Risk Communication course focuses on the interactive exchange of information and opinions about hazards and risks, risk-related factors and risk perception to a variety of stakeholders.
This 3-day in classroom course presents the basics of risk communication as it is practiced in the U.S.A. with applications to food safety.

Prerequisite: While not required, it is recommended that this course be taken after you have completed our Introduction to Risk Analysis and the Regulatory Process and Risk Management course. Those two courses provide contextual information about risk analysis that is not repeated here.

Overview of Topics

Principles of Risk Communication, Knowing your Audience, The Messenger and Risk Communication, Message Development, Channel Choices, Dealing with the Media

Learning Objectives

• Understanding the goals of risk communication
• Differentiating between proactive and reactive risk communication
• Recognizing communication competence and communicator credibility
• Understanding how to communicate expertise and trustworthiness
• Recognizing the importance of nonverbal communication in communicating credibility
• Understanding the phases of message design and the research that corresponds with each phase
• Understanding the practical aspects of message design such as message timing and message organization

This course meets a requirement of the JIFSAN Core Certificate in Food Safety Risk Analysis

This two-day course provides a general overview of epidemiologic principles, methods, and approaches as they relate to food safety and risk assessment. There will be case studies focused on foodborne outbreak investigation and epidemiologic study design needed for food safety research hypotheses. The target audience is food safety professionals wanting to understand the different roles and synergies of epidemiology and risk assessment in regulatory decision making.

Prerequisite:While not required, it is recommended that this course be taken after you have completed our Introduction to Risk Analysis and the Regulatory Process and the Risk Management course. Those two provides contextual information about risk analysis that is not repeated here.

Overview of Topics

Introduction to Epidemiology, Patterns and Measures of Disease, Measurements in Epidemiology (Measures of Association and Impact) and Bias in Observational Studies

Learning Objectives

• Dealing with Foodborne Outbreak investigation
• Understanding patterns and measures of disease
• Facilitated group discussions
• Discussion of Topics and Setting the Scene for Breakout Groups
• Understanding Measurements in Epidemiology
• Study designs to provide data for risk assessment
• Associations for continuous outcomes
• Discussion of bias in observational studies
• Singles studies versus synthesis in RA

This is paired with the Introduction of FDA iRisk® and the combined courses are held over one week. The course will cover basic modeling concepts, including both deterministic and probabilistic modeling approaches. Participants will be taught how to build risk assessment models using Excel with one of the more commonly-used commercial software packages (@RISK). This course will provide participants with a strong foundation in stochastic processes, probabilistic risk assessment and Monte Carlo simulation. Participants will gain a deeper understanding of the principles and mechanics of Monte Carlo simulation, build models using these principles, and learn how to analyze probabilistic models in a risk assessment context. The course will also discuss how to use data and expert opinion when building models. Participants can expect to gain hands-on experience in building and analyzing computer-based probabilistic models and experience some techniques and challenges to expect in presenting their results to various audiences. Learning by example, participants will be given exercises involving elements of real world risk assessments that are being used in current policy and risk management.

Prerequisite: None

It is strongly recommended that this course be taken after you have completed the Risk Management and Qualitative Risk Assessment course. These courses provide contextual information about risk analysis that is not repeated here. Participants should also have basic knowledge of probability and statistics and intermediate level skills in using Microsoft Excel 2003.

Resources

Excel: There are web-based resources that provide introductory Excel 2003 training. Many such courses are available - some at no cost - like the one found at www.videoprofessor.com.
Basic Statistics: The quantitative methods course does not require in-depth knowledge of statistics, but an understanding of basic terminology is necessary. There are web-based resources that provide information about basic theory in probability and statistics. Some examples include http://www.robertniles.com/stats and http://www.statsoft.com/textbook.

Overview of Topics

Going beyond terminology, Introduction to modeling, Deterministic modeling, Probability, Monte Carlo simulations, Triangular, Pert and Beta distribution and Bayes’ Theorem
Learning Objectives

• Understand why models are useful
• Understand important tradeoffs in the design of models
• Understand the differences between deterministic and stochastic models
• Gain a strong foundation in basic probability theory and probability distributions
• Be able to build basic probabilistic models using Excel and @RISK
• Simulation principles and techniques
• Stochastic processes
• Scenario and Sensitivity analysis

This course is paired with Quantitative Risk Assessment and held over one week.  As part of the course we will provide attendees a guided, hands-on opportunity to explore the tool and develop food-safety risk scenarios. The course is conducted in a computer teaching laboratory.

Prerequisite:
It is strongly recommended that this course be taken after you have completed the Risk Management and Qualitative Risk Assessment course. These courses provide contextual information about risk analysis that is not repeated here.  Participants should also have basic knowledge of probability and statistics and intermediate level skills in using Microsoft Excel 2003.

RESOURCES

Excel: There are web-based resources that provide introductory Excel 2003 training. Many such courses are available - some at no cost - like the one found at www.videoprofessor.com.
Basic Statistics: The quantitative methods course does not require in-depth knowledge of statistics, but an understanding of basic terminology is necessary. There are web-based resources that provide information about basic theory in probability and statistics. Some examples include http://www.robertniles.com/stats and http://www.statsoft.com/textbook.

Overview of Topics

Introduction to FDA-iRISK®, Building scenarios in FDA-iRISK®, Guided walk through of working in FDA-iRISK®

Learning Objectives

• Understand usefulness of models and the important tradeoffs in the design of models
• Understand the differences between deterministic and stochastic models
• Gain a strong foundation in basic probability theory and probability distributions
• Be able to build basic probabilistic models using Excel and @RISK
• Case studies: Microbial hazard and Chronic chemical hazard
• Simulation principles and techniques
• Scenario and Sensitivity analysis

Many countries in the world have experienced an exponential increase in the number of food establishments that produce and market food under their jurisdiction. Authorities, however, have experienced a significant decrease in the resources (monetary and personnel) to carry out inspection and surveillance activities. This situation requires countries to optimize and focus their resources to food products and establishments that represent the highest public health risk. This is also true for the private industry where they need to focus their monitoring and verification activities to the hazards, providers and food products that pose the highest risk. This requires the use of risk ranking tools so countries can identify their food safety priorities (biological and chemical) and develop accordingly a risk-based inspection and surveillance. This can also serve as the identification of national food safety issues that will require a risk assessment.

Intended Audience

This course is mainly intended for risk managers at the Ministries of Health and Agriculture in charge of food safety and also quality control and food safety managers from the food industry.

Overview of Topics

WHO Foodborne disease burden online tool, Multi-criteria decision analysis, Decision trees and decision matrices for biological and chemical hazards, Risk ranger and iRisk

Learning Objectives

• Become familiar with risk ranking tools (decision trees, decision matrices, multi-variate decision analysis, online software)
• Develop their own risk ranking tools for a specific situation
• Build a risk-based inspection and surveillance system

Over the last couple of decades the demand for seasonal food year round has dramatically increased outstripping the US’s capacity to meet its own production. In the last ten years, imports to the US have expanded three- fold. The US is having increased dependence on imported foods traveling longer distances than ever for which the production is scattered around the world. At the same time there has been increased demand for safe food due to rising household incomes, technological improvements in measuring contaminants, and the increased media and consumer attention on the risks of food borne illness. In response, many food retailers and food service firms, particularly in developed countries, have adopted private protocols relating to residues, microbial pathogens, field and pack house operation, and traceability. Historically governments have responded with voluntary and occasional mandatory food safety programs yet with extensive changes in demand and increase reliance of products coming from abroad many countries like the US, Canada, EU are revamping their food safety approaches and laws to ensure the food is safe whether produced domestically or abroad.

Intended Audience :

The course is designed for public and private sector stakeholders involved in ensuring products meet domestic and other countries food safety requirements.

Overview of Topics

• Concepts and principles of food/public health policy and law
• US Federal agencies and their involvement in food safety
• The role of the EU European Food Safety Authority (EFSA) in the regulatory process
• Canadian Federal Agencies and their involvement in food safety
• Australian/New Zealand Agencies and their involvement in food safety
• Japanese Agencies and their involvement in food safety

Learning Objectives

• Understand the role of the World Trade Organization
• Discuss the Codex Alimentarius Commission and other intergovernmental organizations involved in food safety
• Understand the role of private standards in food safety
• Understand important concepts in civil liability law

Intended Audience

The course is designed for public and private sector stakeholders involved in ensuring products meet domestic and other countries food safety requirements.

Overview of Topics

Chemical contaminants, Food additives, Pesticides, Veterinary drugs, Safety/Risk Assessment Paradigm

Learning Objectives

• Knowledge of foodborne chemical hazards
• Assessing dietary consumption and exposure of chemicals in food
• Understanding the difference between safety assessments and risk assessments and how to conduct these assessments
• Overview of the types of data and information needed and used to conduct safety and risk assessment for foodborne chemical hazards
• Insight regarding regulatory and international guidance for the conduct of chemical safety and risk assessments