3 Hours Webinar : How to Survive an FDA Food Facility Inspection ?

12:00 PM EDT | 9:00 AM PDT | 11:00 PM CDT Duration 210 Minutes

Webinar Includes : All the training handouts , certificate ,Q/A and 210 mins Live Webinar

"Listen From Angela Bazigos who recently quoted in Wall Street Journal for using training to bring regulatory compliance to the Boardroom"

About 48 million people (1 in 6 Americans) get sick, 128,000 are hospitalized, and 3,000 die each year from foodborne diseases, according to recent data from the Centers for Disease Control and Prevention. This is a significant public health burden that is largely preventable. The FDA Food Safety Modernization Act (FSMA), enables FDA to better protect public health by strengthening the food safety system. It recognizes that preventive control standards improve food safety only to the extent that producers and processors comply with them. Therefore, it will be necessary for FDA to provide oversight, ensure compliance with requirements and respond effectively when problems emerge

Description

About 48 million people (1 in 6 Americans) get sick, 128,000 are hospitalized, and 3,000 die each year from foodborne diseases, according to recent data from the Centers for Disease Control and Prevention. This is a significant public health burden that is largely preventable.

The FDA Food Safety Modernization Act (FSMA), enables FDA to better protect public health by strengthening the food safety system. It recognizes that preventive control standards improve food safety only to the extent that producers and processors comply with them. Therefore, it will be necessary for FDA to provide oversight, ensure compliance with requirements and respond effectively when problems emerge.

Why should you attend 

The Food and Drug Administration (FDA) considers establishment inspection one of its prime enforcement tools. Clearly, this is an important way of determining whether or not food firms are in compliance with the FDA's law and regulations. Many of the regulatory actions FDA takes against food firms are based on FDA's findings during inspections. 

During this webinars you will learn:

        •  Food Safety Basics

        •  Basics of Food Inspections and how they are conducted

        •  The problem areas

        •  Food Inspection Checklist used by the FDA to prepare for inspection

        •  Foreign Food Facility Inspection Program 

        •  How to prepare for a successful inspection

How to respond to any inspection citations and prevent future ones

Areas Covered

Session 1: FDA Food Inspection Basics – 

Length: 90minutes | Time: 12:00 PM ET to 1:30 PM ET

FDA may conduct an inspection of your operation for a variety of reasons, such as a routinely scheduled investigation, a survey, or a response to a reported problem. The investigator will present credentials and "Notice of Inspection" (FDA Form 482) upon arriving at your plant. A knowledgeable person in your firm, such as the plant or production manager, preferably designated ahead of time, should accompany the investigator at all times. It is in your best interest to fully understand FDA's inspection procedures. When you are unsure of certain actions taken by the investigator, don't hesitate to ask questions.

Usually, the investigator will examine your production process, look at certain records and collect samples. At the conclusion of the inspection, the investigator will discuss with your firm's management any significant findings and concerns; and leave with your management a written report of any conditions or practices, which, in the investigator’s judgment, indicate objectionable conditions, or practices. This list of "Inspectional Observations," also called an FDA Form 483, can be used by your firm's management as a guide for corrective action, since the FDA representative will not usually recommend specific corrective measures. Your firm can and should respond to the FDA-483 during the discussion with the investigator. In fact, corrective actions or procedural changes that were accomplished immediately in the presence of the investigator are regarded as positive indications of your concern and desire to voluntarily correct discrepancies.

This session will walk you through this sometimes confusing process and apply it to Food Facility Inspections. It will begin with an overview of the FDA inspection program, followed by outlining inspection goals, inspection process and how the inspection is conducted.  

1. FDA Inspection Program Overview

2. How FDA Conducts Inspections

3. Types of FDA Inspections

4. Possible FDA Inspection Outcomes and how to handle them

5. Food Safety

        a. Food Safety Basics

        b. Consumer Survey on Food Safety

6. Food Inspection Basics

        a. Food Inspection Goals

        b. Communications with Food Facility before, during and after inspection

How the inspection is conducted

 

Session 2: How to Prepare for a Successful Inspection – 

Length: 60 minutes | Time: 1:30 PM ET to 2:30 PM ET

About 48 million people (1 in 6 Americans) get sick, 128,000 are hospitalized, and 3,000 die each year from foodborne diseases, according to recent data from the Centers for Disease Control and Prevention. This is a significant public health burden that is largely preventable.

The FDA Food Safety Modernization Act (FSMA), signed into law by President Obama on Jan. 4, enables FDA to better protect public health by strengthening the food safety system. It recognizes that preventive control standards improve food safety only to the extent that producers and processors comply with them. Therefore, it will be necessary for FDA to provide oversight, ensure compliance with requirements and respond effectively when problems emerge.

This session will explain the key factors for preparing for a successful inspection and will provide attendees with a checklist that FDA would use when inspecting your food facility. Attendees can also use this checklist to ensure inspection readiness in their plant.

1. Key Factors for a Successful Inspection

2. How to prepare for a successful inspection

        a. Rodents

        b. Birds

        c. Insects

        d. Bacteria

        e. Parasites

        f. Molds

        g. Chemical Contaminants

FDA Approved Food Inspection Checklist and How to Use It Session Details

 

Session 3: Foreign Food Facility Inspection Program – 

Length: 60 minutes | Time: 2:30 PM ET to 3:30 PM ET

 

FDA is increasing the number of routine inspections worldwide of foreign food facilities under the jurisdiction of the FDA that export to the United States (processors/manufacturers, packers/repackers, and holders of foods). This increase is mandated based on new requirements included in the FDA Food Safety Modernization Act (FSMA), as enacted by the U.S. Congress and signed into law by the President on January 4, 2011. FDA is also taking similar efforts with regard to domestic facilities to ensure that the U.S. food supply is safe.

Foreign food facility inspections are designed to:

 

• Identify potential food safety problems before products arrive in the United States

• Determine the compliance status of facilities to FDA’s requirements and food safety standards

• Help the agency make admissibility decisions when food products are offered for importation into the United States

• Help ensure that food products under FDA’s jurisdiction meet U.S. requirements under the Federal Food, Drug, and Cosmetic Act

 

This session will explain FDA’s program for foreign food facility inspections, from selection of facilities for inspection to how FDA works with local authorities to what to expect if an inspection has problems.

 

1. Foreign Food Facility Inspection Program

        a. Selecting foreign food facilities for inspection

        b. Notification of foreign Embassies and Competent Authorities

2. How to respond to any inspection citations and prevent future onesFuture Trends in Food Facility Inspections

Q&A

Who will Benefit

• Anyone in a food manufacturer including:

        o Operations

        o Safety officers

        o Compliance and QA

        o Shop floor

        o Washers

        o Microbiologists

        o Etc

        o FDA Food Inspectors

Industries who can attend

This 210-minute online course is intended for professionals in the Food manufacturers Industry. Although not presently stated in the draft , the same guide could be used by FDA Regulated Industries personnel


Speaker Profile

Angela Bazigos

Angela Bazigos.CEO of Touchstone Technologies Inc. She has 40 years of experience in the Life Sciences & Healthcare Industries. Experience combines Quality Assurance, Regulatory Compliance, Business Administration, Information Technology, Project Management, Clinical Lab Science, Microbiology, Food Safety, Turnarounds and Business Development. Past employers / clients include Roche, Novartis, Genentech & PriceWaterhouseCoopers. Positions include Chief Compliance Officer at Morf Media. Co-authored & prototyped 21 CFR 11 guidance with FDA.  Co-authored Computerized Systems in Clinical Research w/ FDA. Patent on speeding up software compliance. Recently quoted in Wall Street Journal for using training to bring regulatory compliance to the Boardroom. National Trainer for Society of Quality Assurance. Comments / collaborates with FDA on new guidance documents. Former President of Pacific Regional Chapter of Society of Quality Assurance. Stanford’s Who’s Who for Life Sciences.

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