The Preventive Controls Rule of the Food Safety Modernization Act (FSMA) requires all food companies to develop a food safety plan in which they identify risks and then implement preventive controls to mitigate risk. Pathogens such as Salmonella are important for the spice industry to consider as they evaluate hazards and ASTA has issued guidance recommending the use of validated microbial reduction processes. FSMA now requires companies to validate these processes.
The series will open with a look at the regulatory requirements. Maile Hermida with Hogan Lovells will provide an overview of the new requirements under the FSMA Preventive Controls rule. She will also review relevant aspects of FSIS’s validation guidance in the absence of guidance from FDA and detail her experience with FDA’s expectations. Dr. James Dickson of Iowa State University will present the remainder of the three part series, beginning with an an explanation of validation and its principles geared to spice industry professionals with no technical expertise. The next two webinars will then move through the more complex issues of designing and conducting a validation study and understanding the results. Below is pricing, schedule and complete outline of each session for the series.
Dr. Dickson previously presented the ASTA webinar series on Microbiology of Spices which serves as the foundation for this series. The Microbiology of Spices series was recorded and is available as background information in preparation for this new information.
Part I – What is validation and why do we care?
a. Intro and overview on FSMA with Maile Hermida of Hogan Lovalls
b. General concepts
c. Regulatory requirements
d. Other guidance: ISO, GFSI
e. Customer expectations
f. Value to operations
Part II – Designing a validation study a. Objective of the study
b. Choice of organism – surrogates vs. naturally occurring
c. Choice of analysis methods
d. Designing the validation study
e. Conducting the study
Part III – Understanding the results and preparing the report a. Interpreting the results
b. Basic considerations of data analysis
c. Drawing appropriate conclusions
d. Preparing the report
e. Next steps
To purchase any part or the series, which can be shown at your convenience…
Purchase Webinars as a download:
Download Registration Form For check payments only
About the Speaker:
James S. Dickson (Jim), Professor
Iowa State University
Department of Animal Science, Inter-Departmental Program in Microbiology
Dr. Dickson is currently a Professor in the Department of Animal Science and the Inter-Departmental Program in Microbiology at Iowa State University. Dr. Dickson’s research focuses on the control of bacteria of public health significance in foods of animal origin. Prior to his appointment at Iowa State University in 1993, he was employed by USDA-ARS as a Research Food Technologist and lead scientist of the Meat Safety Assurance Program, located at the Roman L. Hruska U.S. Meat Animal Research Center, Clay Center, NE. Dr. Dickson was employed in the food industry for three years before joining USDA-ARS.
He is a Fellow in the American Academy of Microbiology, and is a Past President of the International Association for Food Protection. He is also active in the American Society for Microbiology and the Institute of Food Technologists. On behalf of ASTA, Dr. Dickson conducted a scientific review of the FDA’s Draft Risk Profile on Pathogens and Filth in Spices and presented his perspective at the 2014 ASTA Annual Meeting.