Foreign Supplier Verification Programs Course for Foods and Dietary Supplements
UNPA’s FSVP Qualified Individual Workshop Agenda
Sept. 20-21
Sandy, Utah
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.
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
This UNPA 2-day 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 Faculty*
Larisa Pavlick joins UNPA with 20 years of combined experience working within the dietary supplement industry, plus nearly eight years as an investigator at the U.S. Food and Drug Administration. Through robust scientific research and collaboration with her mentors, she has assisted in the formulation of products designed to support the negative effects of nutritional deficiencies, stress, aging and more. During her career, Larisa has dedicated herself to helping ensure consumers receive the benefits of safe and ethical vitamins, minerals, botanicals and other dietary supplement products.
Kathy Gombas is currently a member of the Food Safety Preventive Controls Alliance Steering Committee and co-chair for the International Subcommittee working on industry training, outreach, and technical assistance programs for food companies worldwide. Formerly Kathy was the Senior Advisor for FSMA Implementation with the U.S. Food and Drug Administration’s Center for Food Safety and Applied Nutrition (CFSAN). While at CFSAN, Kathy supported the Agency’s Food Safety Modernization Act (FSMA) implementation efforts including the Preventive Controls Regulator Training and launch of FDA’s FSMA Technical Assistance Network for industry.
* Larisa Pavlick is UNPA’s lead PCQI instructor. Other instructors will train with Larisa depending on class size.
Media Sponsor: INFORMA
Agenda
Thursday, September 20
8:00am - 5:00pm
Continental breakfast - Registration (8:00 am)
Welcome & Introductions (8:30 am)
Chapter 1: Context: FSMA and FSVP
Chapter 2: Setting the Stage : Building the Foundation for the FSVP Process
Chapter 8: Importer Identification
Chapter 3: Overview of Requirements
Recap: Preventive Controls, Produce Safety Session and Appendix 4
Chapter 4: Hazard Analysis
Wednesday, September 21
8:00am - 3:00pm
Continental breakfast - Sign In (8:00 am)
Chapter 4: Hazard Analysis Continued (if needed) (8:30 am)
Chapter 5: Evaluation and Approval of Foreign Supplier
Chapter 6: Foreign Supplier Verification
Chapter 7: Reevaluation of Foreign Supplier
Chapter 9: Records
Chapter 10: FDA Oversight
*Breakfast, beverages and snacks will be provided.
UNPA Members and MOU Partners: $895
Regular Price: $1,095
Seating is limited to 30 attendees.
Course Materials
All course manuals will be provided.
Please Note: In order to receive your completion certificate, you MUST be present for the ENTIRE training. Please do not book your return flight any earlier than 6:00 pm on September 21st.
Venue
Salt Lake Community College, Miller Campus
Miller Professional Development Center Building, Room 213 (Upstairs)
9750 S. 300 W, Rm. 105
Sandy, UT 84070
Lodging
Hilton Garden Inn
277 West Sego Lily Dr., Sandy UT 84070
801.352.9400
Residence Inn by Marriott
270 W. 10000 S., Sandy UT 84070
801.561.5005
Hampton Inn
10690 S. Holiday Park Dr., Sandy UT 84070
801.571.0800
Courtyard by Marriott
10701 S. Holiday Park Dr., Sandy UT 84070
801.571.3600
Fairfield Inn (Marriott)
12117 S. State St., Draper UT 84020
801.572.1200
Springhill Suites by Marriott
12111 State St., Draper, UT 84020
801.572.1200
There is also an extended stay option:
Hyatt House Salt Lake City / Sandy
9685 South Monroe Street, Sandy, UT 84070
801.304.5700
Airports
Salt Lake International is about 18 miles away.
Provo Municipal Airport is about 32 miles away.
