foreign supplier verification program training
November 9-11, 2021
Do you import ingredients?
This course is designed to help participants understand the role of food importers under the new Foreign Supplier Verification Programs (FSVP) rule, part of the Food Safety Modernization Act (FSMA).
Foods covered under the new rule include dietary ingredients, raw materials used in dietary supplements and natural products marketed with a Nutrition Facts panel as a food product.
The training covers the FSVP requirements for dietary supplements, including for raw materials distributors, manufacturers/processors importing components, and for those importing finished products from foreign suppliers.
Many importers are already outside of compliance with this law!
This regulation imposes sweeping new changes on food importers and requires the review and assessment of the food safety practices of foreign suppliers and their compliance history. Foreign suppliers must be approved by importers pursuant to a written program before sourcing. FDA’s regulation also requires new information to be submitted for customs entries: the FSVP importer—the person responsible for FSVP compliance—must now be declared for each importation of FDA-regulated food (including dietary supplements) unless exempt.
Date: November 9-11, 2021
Price: Regular Price $1,799. UNPA Member: $1,499 (Discounts available for multiple participants)
Register: Contact Linda O’Dea, Regulatory and Event Coordinator, linda@unpa.com
About the Instructor
Course will be taught by Larisa Pavlick, UNPA’s Vice President Global Regulatory and Compliance. With over 25 years in the dietary supplement and natural products industry, Larisa is the ONLY instructor who has worked for the Food and Drug Administration. Her primary responsibility was to conduct inspections and investigations for dietary supplement firms and ingredient suppliers. She also has extensive industry knowledge in product development, quality, regulatory affairs, daily operations and technical purchasing. Her experience in the full product life cycle from development purchasing through manufacturing. She is a FSMA Preventive Controls for Human Foods Lead Instructor and is FDA trained and qualified to conduct GMP training. Her unique perspective will provide invaluable insight into the world of FDA audits.
This course will provide participants with the knowledge to implement the requirements of the FSVP regulation. including:
Who or what falls under the FSVP requirement?
For the purposes of FSVP, an importer is the U.S. owner or consignee of a food 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. See Am I Subject to FSVP? for more information.
About the Course
Part 1
Part 1 is an online eLearning including 12 module self-paced modules of FSPCA curriculum.
Part 2
This 3-1/2 day sessions FSVP training course is designed to explain the FSVP rule and the requirements, including hazard analysis, evaluation and approval of a foreign supplier, importer identification, records and FDA oversight. The Food Safety Preventive Controls Alliance (FSPCA) developed this course in consultation with FDA, and therefore training is consistent with the intent of the rule. The rule states a “qualified individual” must perform your FSVP activities. This training is one way to meet the requirement.
At the end of this training program, participants will be able to:
This course meets FDA’s FSVP training requirements. Participants will receive an official FSPCA Foreign Supplier Verification Program certificate issued after attending this training program.
FSVP Qualified Individual Agenda:
Chapter 1: Context: FSMA and FSVP
Chapter 2: Setting the Stage : Building the Foundation for the FSVP Process
Chapter 3: Overview of Requirements
Chapter 4: Hazard Analysis
Chapter 5: Evaluation and Approval of Foreign Supplier
Chapter 6: Foreign Supplier Verification
Chapter 7: Reevaluation of Foreign Supplier
Chapter 8: Importer Identification
Chapter 9: Records
Chapter 10: FDA Oversight
Date: November 9-11, 2021
Price: Regular Price $1,799. UNPA Member: $1,499 (Discounts available for multiple participants)
Register: Contact Linda O’Dea, Regulatory and Event Coordinator, linda@unpa.com
This course is designed to help participants understand the role of food importers under the new Foreign Supplier Verification Programs (FSVP) rule, part of the Food Safety Modernization Act (FSMA).
Foods covered under the new rule include dietary ingredients, raw materials used in dietary supplements and natural products marketed with a Nutrition Facts panel as a food product.
The training covers the FSVP requirements for dietary supplements, including for raw materials distributors, manufacturers/processors importing components, and for those importing finished products from foreign suppliers.
Many importers are already outside of compliance with this law!
This regulation imposes sweeping new changes on food importers and requires the review and assessment of the food safety practices of foreign suppliers and their compliance history. Foreign suppliers must be approved by importers pursuant to a written program before sourcing. FDA’s regulation also requires new information to be submitted for customs entries: the FSVP importer—the person responsible for FSVP compliance—must now be declared for each importation of FDA-regulated food (including dietary supplements) unless exempt.
Date: November 9-11, 2021
Price: Regular Price $1,799. UNPA Member: $1,499 (Discounts available for multiple participants)
Register: Contact Linda O’Dea, Regulatory and Event Coordinator, linda@unpa.com
About the Instructor
Course will be taught by Larisa Pavlick, UNPA’s Vice President Global Regulatory and Compliance. With over 25 years in the dietary supplement and natural products industry, Larisa is the ONLY instructor who has worked for the Food and Drug Administration. Her primary responsibility was to conduct inspections and investigations for dietary supplement firms and ingredient suppliers. She also has extensive industry knowledge in product development, quality, regulatory affairs, daily operations and technical purchasing. Her experience in the full product life cycle from development purchasing through manufacturing. She is a FSMA Preventive Controls for Human Foods Lead Instructor and is FDA trained and qualified to conduct GMP training. Her unique perspective will provide invaluable insight into the world of FDA audits.
This course will provide participants with the knowledge to implement the requirements of the FSVP regulation. including:
- Determining known or reasonably foreseeable hazards with each food imported
- Evaluating the risk posed by the food (based on a hazard analysis and foreign supplier’s performance)
- Using that evaluation to approve suppliers
- Conducting supplier verification activities
- Maintaining documents that are required to demonstrate compliance with the regulation.
Who or what falls under the FSVP requirement?
For the purposes of FSVP, an importer is the U.S. owner or consignee of a food 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. See Am I Subject to FSVP? for more information.
About the Course
Part 1
Part 1 is an online eLearning including 12 module self-paced modules of FSPCA curriculum.
- Will take approximately 6-12 hours to complete based on background and experience.. However, you have up to six months to complete all 12 modules.
- If you do not participate in Part 2 after six months, you will be required to repeat Part 1. No refunds will be given.
- You have up to 9 months to complete Part 2 after completion of Part 1.
- Course includes skills assessments and exercises.
- Upon completion of Part 1 you will receive a certificate by email allowing you to participate in Part 2.
- Part 1 must be completed prior to attending Part 2
Part 2
This 3-1/2 day sessions FSVP training course is designed to explain the FSVP rule and the requirements, including hazard analysis, evaluation and approval of a foreign supplier, importer identification, records and FDA oversight. The Food Safety Preventive Controls Alliance (FSPCA) developed this course in consultation with FDA, and therefore training is consistent with the intent of the rule. The rule states a “qualified individual” must perform your FSVP activities. This training is one way to meet the requirement.
At the end of this training program, participants will be able to:
- Explain the purpose of FSVP requirements
- Define an FSVP importer and a foreign supplier
- Describe the substances subject to and exempt from FSVP requirements
- Describe the FSVP requirements (standard and modified) and to whom they apply
- Discuss the importance of early communication between importers, foreign suppliers and others in the supply chain in meeting FSVP requirements
- Understand the requirements for dietary supplements
This course meets FDA’s FSVP training requirements. Participants will receive an official FSPCA Foreign Supplier Verification Program certificate issued after attending this training program.
FSVP Qualified Individual Agenda:
Chapter 1: Context: FSMA and FSVP
Chapter 2: Setting the Stage : Building the Foundation for the FSVP Process
Chapter 3: Overview of Requirements
Chapter 4: Hazard Analysis
Chapter 5: Evaluation and Approval of Foreign Supplier
Chapter 6: Foreign Supplier Verification
Chapter 7: Reevaluation of Foreign Supplier
Chapter 8: Importer Identification
Chapter 9: Records
Chapter 10: FDA Oversight
Date: November 9-11, 2021
Price: Regular Price $1,799. UNPA Member: $1,499 (Discounts available for multiple participants)
Register: Contact Linda O’Dea, Regulatory and Event Coordinator, linda@unpa.com
Check out the full schedule of courses.