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SQF Edition 8 and FSMA: A Balancing Act

This two-day workshop focuses on SQF Edition 8 food safety fundamentals and their intersection with the Food Safety Modernization Act (FSMA). This course also addresses changes to the divisions between food safety and quality auditing requirements in SQF Edition 8 and how best to integrate these with a FSMA-compliant Food Safety Plan. Attendees will receive a detailed understanding of SQF Edition 8, including the most up-to-date vocabulary and Food Sector Categories and techniques for merging SQF-based food safety and quality management systems with FDA statutory and regulatory requirements. Participants will even receive an overview of auditing and certification of SQF systems and learn how to perform internal audits of the SQF management system.

YOU WILL LEARN

  • Develop, verify, validate and maintain the various elements of SQF Edition 8 and FSMA Food Safety & Quality Management Systems
  • Thorough review of HACCP Plans and their place in SQF Edition 8 and FSMA.
  • Understand SQF Edition 8, including Food Sector Categories & SQF vocabulary
  • Identify the SQF Edition 8 and FSMA System elements and mandatory requirements
  • How to develop, implement and maintain systems compliant with both SQF Edition 8 and FSMA
  • Comparison and contrast of SQF Edition 8 and FSMA requirements
  • Value-added internal audit techniques applicable to any organization
  • Learn the certification requirements of SQF Edition 8
  • Prepare for an SQF Edition 8 Certification Audit and/or FDA regulatory inspection

WHO WILL BENEFIT

A must for suppliers, consultants, food processors, packaging manufacturers, trainers and anyone else interested in learning about how to integrate SQF Edition 8 and FSMA requirements into a single Food Safety and Quality Management System.

REGISTRATION INFORMATION

Course instructional materials, professional certificates, lunch and snacks are included. Please contact us if you have questions, or would like information on available discounts. We can also design a workshop specifically for your organization and present it at our training center or at your site

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Foreign Supplier Verification Programs (FSVP)

The Foreign Supplier Verification Program, or FSVP, is one part of the Food Safety Modernization Act (FSMA) (2011). Published on November 27, 2015, this portion of FSMA deals with the requirements surrounding food safety of imported goods intended for human consumption in the US. Historically, the Food & Drug Administration (FDA) has been responsible for certifying imported foods and ensuring their safety through sampling and testing programs, supplier registrations and on-site audits. Now, the burden of assurance is being shifted to the importer, but the FDA definition of “importer” is not necessarily the same as the colloquial definition – these important distinctions will be discussed in the course.

Why D.L. Newslow & Associates, Inc.? Our workshop is based on the FSPCA’s curriculum, which is the ONLY curriculum recognized as adequate by FDA for the FSVP. This course is offered as a two-day program. We will delve into the requirements of the FSVP, including the definitions of terms such as “importer” and “supplier”, the responsibilities of each party in the food chain, and actions that foreign suppliers will need to take to ensure their products are considered safe and acceptable for distribution in the US food chain.

What are the specific requirements? In a nutshell, the supplier must provide foods that are manufactured and stored under conditions that provide the same level of public health protection as the Preventive Controls for Human Food regulation. The food must also be compliant with allergen labeling requirements and not be considered “adulterated” in the official meaning of the word. We will explain what each of these requirements means, the implications of the law and how your suppliers or importers can expect to comply.

This is a new day in food safety in the United States. The FDA now has expanded enforcement abilities related to food safety in the US, and it is expected they will take advantage of this fact by regulating strictly and ensuring compliance. It will be crucial that importers and suppliers fully understand all the implications of this legislation, which parts apply, and how to demonstrate compliance and maintain the appropriate records to ensure successful continuation of business activities in the US.

WHO WILL BENEFIT?

Any individual or corporation who is involved in the supply, transportation or purchase of food that is imported and intended for consumption in the United States. This course can also be combined with our Sanitary Transportation course, which brings added benefits to entities such as wholesalers, distributers and brokers. Quality Assurance and 

Regulatory personnel must educate themselves to ensure they are passing only the highest caliber of information on to their support networks and clients (internal and external).

WHAT YOU WILL LEARN

  • Definition of terms such as supplier and importer as they relate to the FSVP
  • The intricacies and implications of the law, as well as assistance with determining appropriate compliance activities for your business
  • Best practices and practical applications related to the regulation
  • Dates and requirements for records to demonstrate compliance

 

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Sanitary Transportation

Sanitary Transportation 

This one-day professional workshop covers the new FDA requirements for Sanitary Transportation of Human and Animal Food under the 2011 Food Safety Modernization Act (FSMA). The new regulations include vehicles and transportation equipment, transportation operations, training and records. Most companies are required to be compliant by April 2017. Industry professionals must keep abreast of the changes and be aware of the implications to their sector of the food industry.

Learn how to apply the requirements to your current management system, and improve the safety and quality of overall operations as a result. With a focus on practical techniques and risk assessment, we will discuss the implications of the final rule and what it means to shippers, carriers and receivers involved in the transportation of food at any level. This course is a general overview that is not intended to replace the FSPCA/FDA recognized curriculum.  we are offering this course as an option for those who need to be compliant now and need practical knowledge and techniques for designing systems.

Our uniquely qualified instructors have decades of experience in the food safety industry between them. Debby Newslow is a published author and well-known food safety professional who has had her own training and consulting firm since 1997. Ron Schmidt, Ph.D. is Professor Emeritus at the University of Florida Department of Food Science and Human Nutrition. Each is qualified to teach this course, through years of experience in many industries and a complete understanding of both HACCP and FSMA.

Upon completion of this course, you will have a complete understanding of the new requirements and how they relate to your individual situation. The Food Safety Modernization Act, or FSMA, is completely changing the way we think about the transportation and distribution of human and animal food. Many professionals across the industry are concerned about the changes this rule will require in their day-to-day operations as well as new requirements for management systems. This course will explain the applicability of the requirements and how to tailor your food safety system to meet them. Training materials include a comprehensive manual, slides, explanations of key terms and concepts, and reference materials to help you communicate requirements to your staff. Participants will receive a professional certificate upon completion.

Who Must Comply with the Hazard Analysis and Preventive Controls Rule? The final rule applies to shippers, receivers, loaders and carriers who transport food in the United States by motor or rail vehicle, whether or not the food is offered for or enters interstate commerce.

 

WHO WILL BENEFIT?

Quality, Food Safety, and HACCP managers; food safety HACCP team leaders and team members; those responsible for compliance, warehouse and shipping managers, system implementation associates (i.e. ISO, FSSC, SQF, BRC, IFS, etc.), regulatory managers; associates of firms that ship, receive, or transport food in any capacity; and any associates responsible for shipping and transportation in the food industry. Even experienced food safety managers should take this course as it covers new information never before available in any course or workshop.

WHAT YOU WILL LEARN

  • An understanding of the requirements of FSMA requirements for Sanitary Transportation of Human and Animal Food and how these requirements apply to your organization and industry sector
  • Criteria used to identify and implement specific quality and food safety controls for your organization
  • Requirements for shippers, carriers, and receivers at any stage from farm to table and how these can be integrated into your current Food Safety and Quality Management System
  • Practical applications, common challenges, and pitfalls

REGISTRATION INFORMATION

Refer to the registration descriptions for locations, dates and times. If you are interested in having us present a workshop specifically designed for your organization at your site, please call us at (407) 290-2754.

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FSMA : Putting It All Together

The Food Safety Modernization Act consists of 3 cornerstone rules:

1. Current Good Manufacturing Practice and Hazard Analysis and Risk-based Preventive Controls for Human Food

2. Current Good Manufacturing Practice and Hazard Analysis and Risk-based Preventive Controls for Animal Food

3. The Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption 

As well as 4 companion regulations:

1. Foreign Supplier Verification for Importers

2. Accredited Third Party Certification

3. Mitigation Strategies to Protect Food Against Intentional Adulteration (Food Defense)

4. Sanitary Transportation for Human and Animal Food

This workshop focuses on these Final Rules and their intersection with and relevance to your food safety programs. These are all parts of FSMA that are not expressly covered in a Preventive Controls Qualified Individual (PCQI) certification course. We also include an overview of the Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption.

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FSPCA Preventive Controls for Animal Food (PCQI)

The Food Safety Preventive Controls Alliance (FSPCA) designed this 2.5 day (20 hours) workshop in collaboration with the FDA. It is presently the ONLY FDA-recognized curriculum for the Current Good Manufacturing Practice and Risk-based Preventive Controls for Animal Food requirements. This course is taught by a certified FSPCA Lead Instructor who also has many years of experience as a food safety professional working within this sector.  Successful completion meets the FDA requirements for a FSPCA Preventive Controls Qualified Individual (PCQI) in accordance with the FSMA rule as defined in 21CFR507.  A PCQI is a professional who can manage a Food Safety Plan at a facility in accordance with FSMA requirements. Participants receive an official “FSPCA Preventive Controls Qualified Individual for Animal Food” certificate upon completion.  Lead Instructor: Debby Newslow (lead instructor); a second instructor to be announced. 

The Food Safety Modernization Act, or FSMA, is completely changing the way we think about the manufacture, transportation, distribution and storage of animal food. Many professionals working with animal food (including ingredients, mixed animal feed, pet food, or those who supply the feed) and pet food industries, through either primary products or by-products, are concerned about the changes this rule may require in their day-to-day operations. This course explains these requirements, as well as, provides application examples and decision-making logics. Training materials include: FSPCA comprehensive manual, key terms, concepts, and reference materials to aid in communication tasks.

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FSMA vs. GFSI: Changes Necessary for Compliance

This one day workshop focuses on the Food Safety Modernization Act (FSMA) and how this new regulation relates to current approved Global Food Safety Initiative (GFSI) benchmarked food safety schemes such as FSSC 22000, SQF, BRC, IFS, and GlobalGap. You should take this workshop as a follow-up to the Food Safety Preventive Controls Alliance (FSPCA) Hazard Analysis and Risk-Based Preventive Controls Course.

Our instructors have experience guiding clients in the creation of food safety management programs compliant with both regulatory and voluntary food safety requirements. We always prioritize the needs of attendees when designing the content for each workshop. Customized, small interactive workshops separate us from the competition – come see why our classes are known as the gold standard in food safety and management system education!

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Internal Auditor

The focus of this two-day workshop is on reviewing fundamentals and basic steps critical for internal auditors. This includes forming and asking questions, opening and closing meetings, writing non-conformances, preparing reports and an introduction to process auditing. Auditing concepts are applicable to numerous internal and external auditing approaches, including those compliant with HACCP, GFSI approved schemes (i.e. FSSC, IFS, BRC, SQF, etc.), ISO standards, and specific company second party (i.e. suppliers, corporate programs, etc.) standards and protocols. Class content and specifics are adapted based on the needs of our workshop attendees, as well as, case studies discussed are focused on their particular industries. The standard currently used by the company or the future standard to be implemented is also discussed during this workshop. Debby Newslow, primary instructor, shares her insights based on her first-hand experience and information gleaned from her latest book, a CRC Press publication: Food Safety Management Programs: Applications, Best Practices, and Compliance.

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FSPCA Preventive Controls for Human Food (PCQI)

PCQI: Preventive Controls Qualified Individual Workshop – FDA Recognized Course Curriculum by FSPCA

Our one-of-a-kind 21 CFR 117 training allows the individual to gain a complete understanding of the new requirements and how they apply to your organization. The Food Safety Preventative Controls Alliance (FSPCA) designed this 2.5-day course in collaboration with the FDA. It is the ONLY PCQI course presently recognized by the FDA as meeting the new requirements. Our course is taught by Lead Instructors for the FSPCA who have successfully completed the “Train the Trainer” curriculum required to be an official instructor. Upon completing the course, you will meet the requirements as a FSPCA Preventive Controls Qualified Individual (PCQI) who can manage a food safety preventive controls program in accordance with the Hazard-Analysis and Preventive Controls Rule of the US Food and Drug Administration (21 CFR 117).

Requirements of the new regulations include distinctive characteristics that differ from HACCP and from GFSI protocols (SQF, BRC, FSSC 22000) in important ways. Many activities required by the final rule must be conducted or overseen by a Preventive Controls Qualified Individual, or PCQI. This person is defined as “…someone that has successfully completed training in the development and application of risk-based preventive controls as defined by FDA…” 21 CFR 117 training materials include a comprehensive manual, slides, explanations of key PCQI terms and concepts, and example model Food Safety Plans and reference material to help you communicate requirements to your staff. Participants receive an official FSPCA PCQI certificate upon completion.

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Why Should I Attend FSSC 22000 Implementation and Awareness?

  1. FSSC 22000 is growing in popularity as a GFSI Certified Program Owner (CPO). It is a well-defined food safety management standard that allows companies flexibility in deciding how to integrate specific requirements into established organizational system activities.  Understanding the process of adapting current company policies and procedures to meet the value-added requirements of the standard is critical for success.
  2. FSSC 22000 version 4.1 went into effect on January 1, 2018. All current FSSC 22000-compliant facilities need to understand the changes and update their systems to ensure they are compliant with Version 4.1.
  3. Even if currently approved to an alternate GFSI-approved CPO (formally referred to as a food safety management scheme) such as SQF or BRC, it is important to understand industry best practices, which are highlighted in this training. It may also be necessary to evaluate suppliers that choose FSSC 22000; this training will explain what they must do to achieve and maintain this certification, which will help with Supplier Evaluation and Approval under FSMA.
  4. The current revision (4.1) emphasizes new requirements for food defense and food fraud. Although we recommend attending our Food Defense workshop* to truly understand vulnerability and risk, it is still necessary to clearly define what must be changed. To understand and ensure compliance, it is necessary to first understand what is being asked of us.
  5. If currently certified to FSSC 22000, then companies must comply with the many updated requirements of Ver 4.1 in their 2018 calendar year upgrade audits. As with any audit, the company must define, implement and provide at least 90 days’ evidence (records) that it is maintaining compliance on an on-going basis. The sooner this training is received, the sooner this documentation process can proceed.
  6. Debby Newslow is the primary instructor for both this class and the Internal Auditing workshop being presented after this course. Drawing from her experience as an FSSC 22000 Lead Auditor, Debby will explain best practices, both for those implementing a new system and for those involved in the on-going maintenance of a compliant, sustainable and effective management system.
  7. While many companies have one or two people who have attended a formal training, Murphy’s Law (and the new requirement for unannounced audits) dictates that the auditor will likely arrive when those persons are on vacation, or out sick. It is critical that we train enough back-ups to feel confident that we can welcome an auditor any day, any time, and on any shift.

*Combination discounts are always available for attendees wishing to sign up for multiple workshops. Call us at (407) 290-2754 to find out how much you can save.

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FSMA Compliance Information for the Intentional Adulteration Rule

Strategies to Protect Food Against Intentional Adulteration (FSMA) Compliance Information:

Compliance dates for the FSMA Food Defense Rule (Mitigation Strategies to Protect Food Against Intentional Adulteration, 21 CFR 11 and 121) are on the horizon, with the first date arriving three years after the effective date of the rule, or July 26, 2019.

Who must comply, and with which portions of the rule?

Exemptions have been granted to the following industry sectors (from the Federal Register Number 2016-12373, retrieved December 27, 2017):

  • The rule does not apply to a very small business (e., a business, including any subsidiaries or affiliates, averaging less than $10,000,000, adjusted for inflation, per year, during the 3-year period preceding the applicable calendar year in both sales of human food plus the market value of human food manufactured, processed, packed, or held without sale, e.g., held for a fee), except that the facility is required to provide for official review, upon request, documentation sufficient to show that the facility qualifies for this exemption.
  • This rule does not apply to the holding of food, except the holding of food in liquid storage tanks.
  • This rule does not apply to the packing, re-packing, labeling, or re-labeling of food where the container that directly contacts the food remains intact.
  • This rule does not apply to activities of a farm that are subject to section 419 of the Federal Food, Drug, and Cosmetic Act (Standards for Produce Safety).
  • This rule does not apply with respect to alcoholic beverages at a facility that meets certain conditions.
  • This rule does not apply to the manufacturing, processing, packing, or holding of food for animals other than man.
  • This rule does not apply to on-farm manufacturing, processing, packing, or holding by a small or very small business of certain foods identified as having low-risk production practices if such activities are the only activities conducted by the business subject to section 418 of the FD&C Act.

Compliance dates for businesses subject to the rule, from the Federal Register Number 2016-12373 (information retrieved December 27, 2017):

  • Facilities, other than small and very small businesses, have 3 years after the effective date to comply with part 121. (July 26, 2019)
  • Small businesses (e., those employing fewer than 500 full-time equivalent employees) have 4 years after the effective date to comply with part 121. (July 27, 2020)
  • Very small businesses (e., businesses that have less than $10,000,000, adjusted for inflation, per year, during the 3-year period preceding the applicable calendar year in both sales of human food plus the market value of human food manufactured, processed, packed, or held without sale) have 5 years after the effective date to comply with § 121.5(a). (July 26, 2021)