10.23.17
In an effort to assist its members and the broadernatural health products industry in improving and maintaining regulatory compliance, the United Natural Products Alliance (UNPA) is now offering onsite education and training courses for food and dietary supplement companies.
UNPA said its onsite education and trainings provide a host of efficient and cost-effective staff trainings that can save companies time, money and travel costs, plus they allow for confidential, proprietary discussions and solutions with staff and trusted suppliers as they develop policies and procedures to ensure regulatory compliance.
“These onsite, in-house trainings allow UNPA to further its mission to help companiesreach and maintain compliance with ever-evolving federal regulatory requirements,”said UNPA President Loren Israelsen. “The onsite trainings have been met with universal approval as a smart, efficient way to accomplish staff education and raise the bar for quality initiatives in the dietary supplement category.”
UNPA’s onsite training program is led by Larisa Pavlick, UNPA’s VP of global regulatory & compliance, a 20–year industry veteran, who most recently served as an investigator for the Food and Drug Administration’s (FDA) Denver district office. As an FDA investigator, Ms. Pavlick has been in more than 200 facilities, and she is a lead instructor for the standardized coursework for Preventive Controls Qualified Individual (PCQI), part of the requirements under the Food Safety Modernization Act (FSMA). She will shortly become a lead instructor to teach standardized training for Foreign Supplier Verification Programs (FSVP), also a requirement of FSMA.
Ms. Pavlick has previously completed onsite training for companies in Oregon, Texas, Italy, Norway and Canada.
UNPA’s onsite training offerings include:
FSMA Executive Overview
This overview will introduce a company’s team to the Food Safety Modernization Act(FSMA). Topics include Preventive Controls Qualified Individual (PCQI), Foreign SupplierVerification Programs (FSVP), the new food current Good Manufacturing Practices(GMP), requirements for a Food Safety Plan, responsibilities of ownership, management and staff and much more.
FSMA: Preventive Controls for Human Food, including Preventive Controls Qualified Individual (PCQI)
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 need this training.
FSMA: Foreign Supplier Verification Programs (FSVP)
If a company imports ingredients, it needs to comply with FSVP. This comprehensive training will help achieve that. UNPA’s Foreign Supplier Verification Programs (FSVP)training is based on the training curriculum created by FSPCA.
Introduction to 21 CFR Part 111 (GMPs)
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.
Advanced 21 CFR Part 111 (GMPs)
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.
Inspection Documents Review
If a company has 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 its documents and provide suggestions and areas of improvement.
Facilities Walkthrough
During a “walkthrough” of a facility, UNPA will strive to provide suggestions regardingareas of improvement in all aspects of the manufacturing process as it relates to compliance with all applicable U.S. regulations.
Mock Facilities Inspection
UNPA will conduct an FDA-style audit of a facility—using the same techniques used byFDA investigators—that includes a specific review of two products. Evaluations include the facility, employee practices, quality system, manufacturing operations and documentation. Included is a summary of potential areas for improvement.
Many of these onsite training courses, especially the overview courses, can be combined during a single visit by UNPA staff, the organization said, making it easier for companies to meet their regulatory obligations. For more complete training session descriptions, including who should attend each session, visit http://www.unpa.com/ABOUT/Education-Training/Onsite-Training.
For more information about the UNPA onsite trainings, contact Kira Olsen, UNPA’s director of membership services and events, 801.474.2572.
UNPA said its onsite education and trainings provide a host of efficient and cost-effective staff trainings that can save companies time, money and travel costs, plus they allow for confidential, proprietary discussions and solutions with staff and trusted suppliers as they develop policies and procedures to ensure regulatory compliance.
“These onsite, in-house trainings allow UNPA to further its mission to help companiesreach and maintain compliance with ever-evolving federal regulatory requirements,”said UNPA President Loren Israelsen. “The onsite trainings have been met with universal approval as a smart, efficient way to accomplish staff education and raise the bar for quality initiatives in the dietary supplement category.”
UNPA’s onsite training program is led by Larisa Pavlick, UNPA’s VP of global regulatory & compliance, a 20–year industry veteran, who most recently served as an investigator for the Food and Drug Administration’s (FDA) Denver district office. As an FDA investigator, Ms. Pavlick has been in more than 200 facilities, and she is a lead instructor for the standardized coursework for Preventive Controls Qualified Individual (PCQI), part of the requirements under the Food Safety Modernization Act (FSMA). She will shortly become a lead instructor to teach standardized training for Foreign Supplier Verification Programs (FSVP), also a requirement of FSMA.
Ms. Pavlick has previously completed onsite training for companies in Oregon, Texas, Italy, Norway and Canada.
UNPA’s onsite training offerings include:
FSMA Executive Overview
This overview will introduce a company’s team to the Food Safety Modernization Act(FSMA). Topics include Preventive Controls Qualified Individual (PCQI), Foreign SupplierVerification Programs (FSVP), the new food current Good Manufacturing Practices(GMP), requirements for a Food Safety Plan, responsibilities of ownership, management and staff and much more.
FSMA: Preventive Controls for Human Food, including Preventive Controls Qualified Individual (PCQI)
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 need this training.
FSMA: Foreign Supplier Verification Programs (FSVP)
If a company imports ingredients, it needs to comply with FSVP. This comprehensive training will help achieve that. UNPA’s Foreign Supplier Verification Programs (FSVP)training is based on the training curriculum created by FSPCA.
Introduction to 21 CFR Part 111 (GMPs)
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.
Advanced 21 CFR Part 111 (GMPs)
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.
Inspection Documents Review
If a company has 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 its documents and provide suggestions and areas of improvement.
Facilities Walkthrough
During a “walkthrough” of a facility, UNPA will strive to provide suggestions regardingareas of improvement in all aspects of the manufacturing process as it relates to compliance with all applicable U.S. regulations.
Mock Facilities Inspection
UNPA will conduct an FDA-style audit of a facility—using the same techniques used byFDA investigators—that includes a specific review of two products. Evaluations include the facility, employee practices, quality system, manufacturing operations and documentation. Included is a summary of potential areas for improvement.
Many of these onsite training courses, especially the overview courses, can be combined during a single visit by UNPA staff, the organization said, making it easier for companies to meet their regulatory obligations. For more complete training session descriptions, including who should attend each session, visit http://www.unpa.com/ABOUT/Education-Training/Onsite-Training.
For more information about the UNPA onsite trainings, contact Kira Olsen, UNPA’s director of membership services and events, 801.474.2572.
