Onsite Education and Training

In addition to regularly scheduled conferences, education and trainings, the United Natural Products Alliance offers onsite education and training courses for natural and organic foods and dietary supplement companies. UNPA’s Larisa Pavlick, VP, Global Regulatory & Compliance, who is a former Food and Drug Administration (FDA) investigator, leads a team of highly experienced Instructors that are available to provide certified in-house training to help meet all your compliance obligations.

Onsite training offers a number of benefits for companies, including the ability to train multiple team members and/or supply chain partners at once, while in many cases eliminating travel and lodging expenses. It also provides attendees with an opportunity to confidentially compare notes, share ideas, collectively work through case studies and learn from business-specific, question-and-answer sessions as a team.

Many of these onsite-training courses, especially the overview courses, can be combined during a single visit by UNPA staff.

 

UNPA ONSITE TRAININGS

Food Safety Modernization Act (FSMA)

    FSMA Executive Overview

    Preventive Controls for Human Food, including Preventive Controls Qualified Individual (PCQI)

    Foreign Supplier Verification Programs (FSVP)

Good Manufacturing Practices (GMPs)

    Introduction to 21 CFR Part 111 (GMPs)

    Advanced 21 CFR Part 111 (GMPs)

    Inspection Documents Review

    Facilities Inspections

    Facilities Walkthrough

    Mock Inspections

 

Download a PDF of the onsite education and training courses offered by UNPA.


FSMA Executive Overview

Course: UNPA FSMA-EO

Time: 1-2 hours

Class Size: open

Location: TBD by client

Description: This overview will introduce your team to the Food Safety Modernization Act (FSMA). Topics include Preventive Controls Qualified Individual (PCQI), Foreign Supplier Verification Programs (FSVP), the new food current Good Manufacturing Practices, requirements for a Food Safety Plan, responsibilities of ownership, management and staff and much more.

During this overview, UNPA will explain the genesis and reach of the new law for food and finished dietary supplement manufacturers and ingredient suppliers and how it applies to brand holders, distributors, warehouses and contract manufacturing services.

 

Topics include:

  • New definitions, including qualified individuals, Preventive Controls Qualified Individuals (PCQI), Foreign Supplier Verification Programs (FSVP) and their unique responsibilities
  • FDA expectations in the new food current Good Manufacturing Practices under 21 CFR Part 117 (FSMA)
  • How 21 CFR Part 117 is different from 21 CFR Part 110 (which will become obsolete as compliance dates are reached)
  • The requirements for a Food Safety Plan
  • The responsibilities of ownership, management and staff
  • Hazard analysis and the basics of preventive controls
  • An introduction to the records requirements and the supply chain management requirements of 21 CFR Part 117 

Who should attend? This course is designed for executive management or new staff members, who need to understand the basics of these important new regulations, but without the “nitty-gritty” details required for daily operations staff. This overview is appropriate and recommended for all staff within dietary supplement, dietary ingredient and food facilities, including office, manufacturing, operations, quality, regulatory and executive personnel.

Fee: Contact Kira Olsen, 801.474.2572, so that we can design and customize a training program that best fits your needs.

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Preventive Controls for Human Food, including Preventive Controls Qualified Individual (PCQI)

Course: UNPA FSMA-PCQI

Time: 2.5 days

Class Size: Limited to 15 per instructor, with a cap of 30

Location: TBD by client

Description: UNPA’s PCQI training is the “standardized curriculum” referred to in the U.S. regulations and includes examples and teaching models’ specific to the dietary supplement industry. Most food companies and all dietary ingredient companies require this training or equivalent training.

Preventive Controls for Human Food (21 CFR Part 117) is one of the seven foundational rules of FSMA. PCQI training is based on the training curriculum created by the Food Safety Preventive Controls Alliance (FSPCA).

Our UNPA PCQI courses cover the entire FSPCA curriculum, plus examples and teaching models’ specific to the dietary supplement industry. Our goal is to ensure you understand how FSMA and PCQI apply to our industry.  For in-house/on-site training we can add training materials and teaching examples to customize the course around your products.

With the successful completion of the course and the required exercises, a certificate will be issued. Staff must participate in the full 20 hours of training and complete the exercises successfully to receive a certificate of completion issued by FSPCA. Training materials will be provided including a manual, workbook and handouts. 

For more information about PCQI, see “Who’s Your PCQI?” and PCQI FAQs

Raw material and dietary ingredient suppliers, anyone marketing food products with a Nutritional Facts label, including functional foods (shakes, bars, greens, gummies, etc.) for consumption in the United States, and anyone seeking training as a PCQI.

Fee: Contact Kira Olsen, 801.474.2572, so that we can design and customize a training program that best fits your needs.

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FSMA: Foreign Supplier Verification Programs (FSVP)

Course: UNPA FSMA-FSVP

Time: 2 days

Class Size: Limited to 15 per instructor, with a cap of 30

Location: TBD by client

Description: Foreign Supplier Verification Programs (FSVP) is one of the seven foundational rules of the Food Safety Modernization Act (FSMA). FSVP is a program that importers of foods and dietary ingredients must have in place to verify that their foreign suppliers are producing food and food products, including dietary ingredients, in a manner that provides the same level of public health protection as the preventive controls or produce safety regulations, as appropriate, and to ensure that the foreign supplier’s product is not adulterated and is not misbranded with respect to allergen labeling.

If you import ingredients, you need to comply with FSVP. This comprehensive training will help you do that. UNPA’s Foreign Supplier Verification Programs (FSVP) training is based on the training curriculum created by FSPCA. Unlike PCQI training, it is not required to adhere to a “standardized curriculum,” but upon completion of this course, your staff will understand the regulations and obligations to meet all of the FSVP requirements. 

Importers of food and dietary ingredients are responsible for:

  • Determining known or reasonably foreseeable hazards with each food
  • Evaluating the risk posed by a food, based on the hazard analysis, and the foreign supplier’s performance
  • Using that evaluation of the risk posed by an imported food and the supplier’s performance to approve suppliers and determine appropriate supplier verification activities
  • Conducting supplier verification activities
  • Conducting corrective actions

The UNPA FSVP training includes the FSPCA curriculum, plus examples and teaching models specific to the dietary supplement industry. Our goal is to ensure you understand how FSMA and FSVP apply to the dietary supplement industry and your company. For in-house/onsite training, UNPA can add training materials and teaching examples to customize the course around your product categories.

With the successful completion of the course and the required exercises, a certificate will be issued. Staff must participate in the full training and complete the exercises successfully to receive a certificate of completion issued by FSPCA. Training materials will be provided including a manual, workbook and handouts. 

Who should attend? For the purposes of FSVP, an importer is the U.S. owner or consignee of a food or dietary ingredient offered for import into the United States. If there is no U.S. owner or consignee, the importer is the U.S. agency or representative of the foreign owner of consignee at the time of entry, as confirmed in a signed statement of consent. Additionally, anyone that has an interest in ensuring that the requirements of the FSVP rule are met, including business owners, suppliers, exporters and brokers, are encouraged to attend this training. 

Fee: Contact Kira Olsen, 801.474.2572, so that we can design and customize a training program that best fits your needs.

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Introduction to 21 CFR Part 111 (GMPs)

Course: UNPA GMP-INTRO

Time: 1-2 hours

Class Size: Open


Location: TBD by client

Description: This training is an introduction to the concepts and expectations of Good Manufacturing Practices (GMPs) in 21 CFR Part 111. Topics include the general requirements, resources to help understand the elements of and what to expect during an FDA inspection, plus much more.

Topics include:

  • The general requirements of 21 CFR Part 111
  • Resources to help understand the elements of and what to expect during an FDA inspection
  • How to effectively and successfully work with the FDA investigator
  • How to avoid common investigation pitfalls

Who should attend? This course is for anyone working in the dietary supplement industry, including staff working at companies manufacturing, packaging, distributing or holding finished goods, including office, manufacturing, operations, quality and regulatory personnel, plus the executive team. This course can also be used as an annual GMP training for all staff.

Fee: Contact Kira Olsen, 801.474.2572, so that we can design and customize a training program that best fits your needs.

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Advanced 21 CFR Part 111 (GMPs)

Course: UNPA GMP-ADV

Time: 2 days

Class Size: open

Location: TBD by client

Description: This training is a comprehensive, in-depth course designed to help companies fully understand their responsibilities under the regulations and to help them be prepared for their next FDA inspection. This course may help meet the requirements of 21 CFR Part 111.12 for qualified employees within a dietary supplement firm. This course includes the FSMA 21 CFR Part 117 requirement for training in the principles for food hygiene and food safety, plus employee health and hygiene.

Attendees will receive a full understanding of the dietary supplement regulations, laws and regulatory guides, including the Food, Drug and Cosmetic Act, 21 CFR Part 111, cGMP for dietary supplements, as well as public FDA references and resources used extensively by FDA investigators.

 

This course includes the FSMA 21 CFR Part 117 requirement for training in the principles for food hygiene and food safety, plus employee health and hygiene.

 

Topics include:

  • The state of the industry, including trends and recent regulatory actions
  • A review of new and evolving regulations and current events
  • What FDA is looking at during the course of an inspection
  • How to efficiently and effectively coordinate and prepare staff for and during the inspection
  • The top ten FDA citations
  • How to implement solutions for the top citations

Attendees will receive a full review of the complete inspection, including:

  • The walkthrough
  • Manufacturing operations
  • Document review
  • Product review
  • How an inspector evaluates compliance
  • The requirement for written procedures
  • How to write and implement scientifically valid specifications
  • The regulatory classifications of investigations
  • The close-out meeting
  • ·Post-inspectional activities, including a voluntary written response to a form FDA-483 (Inspectional Observations)

Who should attend? This training session has been designed for anyone working in the dietary supplement industry, including companies manufacturing, packaging, distributing or holding finished goods, and is especially pertinent for manufacturing, operations, quality and regulatory personnel, as well as owners and executives.

This course can also be used as an annual GMP training for all staff.

Fee: Contact Kira Olsen, 801.474.2572, so that we can design and customize a training program that best fits your needs.

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Inspection Documents Review

Course: UNPA GMP-DOCS

Time: 1 hour, or as needed

Location: Onsite or remote

Description: Do you have questions regarding compliance with dietary supplement regulations related to specific “written procedures” or record-keeping requirements that are part of an FDA facilities inspection? UNPA can review your documents and provide suggestions and areas of improvement, based on the background and experience of a former FDA investigator with more than 200 facilities inspections.

Fee: Contact Kira Olsen, 801.474.2572, so that we can design and customize a training program that best fits your needs.

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Facilities Walkthrough

Course: UNPA GMP-WALK

Time: 1-2 hours

Description: During a “walkthrough” of your facility, UNPA will strive to provide suggestions regarding areas of improvement in all aspects of your manufacturing process as they relate to compliance with all applicable U.S. regulations. We will share with you what an investigator might be looking for and areas of concern. This walkthrough is designed to help your staff be more prepared for an FDA audit. If requested, during this walk through, we will provide a summary of the regulatory requirements related to facility, employee practice, plant and grounds, manufacturing observation, storage and allergen controls.

Who should attend? This walkthrough of your facility is designed for anyone working in the dietary supplement industry, including brand holders and companies manufacturing, packaging, distributing or holding finished goods.

Fee: Contact Kira Olsen, 801.474.2572, so that we can design and customize a training program that best fits your needs.

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Mock Facilities Inspection

Course: UNPA GMP-MOCK

Time: approximately 2-3 days depending on the level of detail desired

Location: TBD by client

Description: UNPA will conduct an FDA-style audit of your facility—using the same techniques used by FDA investigators—that includes a review of two products. Evaluations include the facility, employee practices, quality system, manufacturing operations, documentation and a full product review. Included is a summary of potential areas for improvement.

During a mock facilities inspection, UNPA will conduct an FDA-style audit of your facility that includes a review of at least two dietary supplement products. The mock audit will be conducted using 21 CFR Part 111, current good manufacturing practice for dietary supplements.

Product review will begin with supplier qualification, raw material receipt, specifications, testing and monitoring, batch records and master manufacturing record review and finished product-release criteria. You will also receive a summary of potential areas for improvement to help with compliance.

Who should attend? The UNPA mock facilities inspection is designed to help brand owners, manufacturers of dietary supplements or foods, contract manufacturers or packaging companies for the dietary supplement and natural products industry be fully prepared for the successful completion of a “real” FDA inspection.

Fee: Contact Kira Olsen, 801.474.2572, so that we can design and customize a training program that best fits your needs.

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More courses will be added in the near future.








 


Larisa-in-Norway-adj-72dpi

UNPA’s Larisa Pavlick recently conducted onsite PCQI training for a client in Norway.

Indena attendees considered this FSMA/PCQI training very useful as a highly convenient way to understand the key points of this new law and regulations. Particularly, working together as an internal team on practical examples, we had the benefit of discussing and clarifying the questions relevant to our business that are unavoidable with any new regulation. It was also important for us to be trained by a person that is an expert in this specialized field of botanical extracts, who also has expertise from her work at FDA.

Ernesto Marco Martinelli,
Group-QA Manager & Regulatory for Indena