Course Description:
This seminar will present an overview of proactive measures that food facilities that manufacture, process, pack or hold human food should take to be audit-ready all the time, such as:
- Performing a hazard analysis
- Developing and implementing adequate and effective HACCP plans and food safety plans (under FSMA)
- Performing end-product and/or environmental sampling
- Auditing suppliers of high risk food ingredients and/or sampling and testing incoming ingredients
It will identify what high risk foods are in relation to food safety and current FDA regulations applicable to the processing and packing of high risk foods. It will give special emphasis to the processing of low acid canned foods (Part 113), seafood (Part 123), juice (Part 120) and dry read to eat (RTE) foods (Part 117 – proposed rule under FSMA).
Further, the course will provide valuable insights into what FDA investigators focus on during FDA high-risk food inspections, the most common types of deficiencies that high-risk food processors have been cited for on FD Form 483 and how to act, especially in response to inspectional observations by investigators and follow-up correspondence with FDA. The seminar will provide insights on what facilities that manufacture, process, pack and hold human food can expect when FDA’s proposed new preventative control regulation (21CFR Part 117) becomes effective as a final rule sometime in 2015. The seminar will conclude with a presentation on the control of salmonella in low moisture foods plus a class exercise pertaining to the development of a food safety plan for a dry ready to eat (RTE) food.
In all, the primary areas covered in the course are:
- What characterizes high risk foods as compared to low risk foods
- Brief overview of FDA high risk food regulations: (a) 21 CFR Part 113 (LACF-HACCP Based), 21CFR Part 114 (Acidified Foods – HACCP Based), 21CFR Part 123 – Seafood (HACCP); 21CFR Part 120 – Juice (HACCP); Preventative Control Regulation – Proposed under FSMA – 21 CFR Part 117
- The importance of being audit-ready all the time
- The importance of well written, effective standard operating procedures
- The importance of conducting a thorough and effective hazard analysis
- The importance of developing and implementing adequate HACCP and food safety plans (FSMA)
- The difference between traditional HACCP plans and food safety plans under Part 117, Subpart B and Subpart C (HARPC)
- What FDA investigators look for during high risk food inspections
- How to act during an FDA inspection and correspond with FDA
- Facility registration and record establishment/maintenance/availability requirements under FSMA
- The Reportable Food Registry (RFR) reporting requirements for facilities that manufacture, process, prepare and pack human food
Learning Objectives:
- What high risk foods are in relation to food safety
- What FDA regulations apply to high risk foods processed at your plant
- The new FDA preventative control regulation under FSMA – 21CFR Part 117
- The importance of SOPs that are effectively written and implemented
- When a hazard analysis and HACCP plan or food safety plan are required
- How to write and manage an acceptable HACCP plan
- How to prepare acceptable monitoring, corrective action and verification records under HACCP and FSMA
- What FDA investigators focus on during FDA high risk inspections
- Examples of FDA deficiencies reported on Form 483 during high risk food inspections
- The importance of being audit ready
- How to act during FDA inspections and correspond with FDA after the inspection, especially in response to deficiencies cited on Form FD483
Who Will benefit:
Manufacturers of food, processors, food packaging companies, warehousing and distribution companies and importers sourcing food and beverages from overseas will benfit from this seminar. The personnel who will benefit include:
- Plant managers
- Quality control managers and employees
- Regulatory affairs
- Documentation
- Production managers and employees
- Microbiologists
- Scientists
- Importers/exporters
- Raw materials and ingredient manufacturers
- Consultants
- Professors of food science
- Sales
Day One (8:30 AM – 4:30 PM) | Day Two (8:30 AM – 4:30 PM) | ||
Registration Process: 8:30 AM – 9:00 AM Session Start Time: 9:00 AM
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Meet Your Instructor
Brian Hendrickson Director, BPHendrickson Consulting LLC; Retired FDA National Food Expert Brian Hendrickson is a retired FDA National Food Expert with more than 35 years’ experience with the agency. As a national expert, he helped develop FDA regulatory policy for high-risk foods and trained FDA and state food inspectors nationwide in food technologies and related hazards, FDA regulations and inspection techniques. He has conducted FDA inspections of food manufactures internationally. Since his retirement in 2011, Mr. Hendrickson has been self-employed as a food industry consultant, served a 3-year appointment as assistant professor of food science at Purdue University and taught food safety courses at Purdue and 4 other universities nationwide. |
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