UNITED NATURAL PRODUCT ALLIANCE

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    • UNPA Members >
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      • Political Advisors
    • Policies & Endorsements
    • Education and Training
    • Photo Galleries >
      • Members' Retreat 2019
      • China Delegation 2018
      • UNPA 2019 Staff Retreat
    • UNPA Headquarters
    • Testimonials
  • News
    • UNPA News
    • UNPA In the News
    • Media Releases
    • Member/MOU Partner News
    • Employment Opportunities
  • Member Resources
    • Regulatory Resources >
      • GMPs >
        • Regulatory Dietary Supplements
      • FSMA >
        • PCQI
        • FSVP
      • Organics
      • Labeling/Claims >
        • Nutrition Facts label
      • Guidelines/Best Practices >
        • Monographs
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      • Global >
        • Canada
    • Member Memos
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    • Expert Insights Webinars
    • Education Archive
    • Exclusive Member Offers
    • Member Logos
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    • 2021 Training Schedule >
      • PCQI Training
      • GMP Inspection Training
      • FSVP Training
    • 2020 DSRS Speakers
    • Industry Calendar of Events
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UNPA tRAINING

​GMP Inspection Training - June 8-10, 2021

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COURSE DESCRIPTION
The GMP 111 three 1/2 day virtual training is a comprehensive course designed for owners, operators, operations staff to help you understand your responsibilities under the law. This course may help you to meet the requirements of 21 CFR Part 111.12 for qualified employees within a dietary supplement firm.  During these intense two days, Larisa will explain what the FDA is looking at during the course of an inspection with the objective of helping you to be more prepared.  She will share with you the top ten FDA citations and provide information to help you implement solutions for each.  

The course will summarize the state of the industry including trends and recent regulation regulatory action, discuss new and evolving regulations, and current events. You will get a full understanding of dietary supplement regulation, laws, and regulatory guides including the Food, Drug and Cosmetic Act, 21 CFR Part 111- cGMP for Dietary Supplements, and public FDA reference and resources used extensively by the FDA investigators. 

Date: June 8 - 10, 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.Finally, Larisa will discuss the regulatory classifications of investigations, the close-out meeting, and discuss post-inspectional activities including a voluntary written response to a form FDA-483 (Inspectional Observations).

Over the course of these three days, we will go through a full dietary supplement GMP investigation from Larisa's perspective as a former FDA investigator and will share with you her experience and how she would evaluate compliance from the general walk through, to observing manufacturing operations, document review, and most importantly- product review.  This course will also demystify the requirement for “written procedures” and help you to write and implement specifications which are scientifically valid and help you to understand the regulatory requirements.

​Finally, Larisa will discuss the regulatory classifications of investigations, the close-out meeting, and discuss post-inspectional activities including a voluntary written response to a form FDA-483 (Inspectional Observations).


You’ll learn:
  • We will focus on how to be prepared when the FDA returns, how to audit your suppliers virtually, what have we learned about supply chain and managing adulteration during this new era, and COVID-19 refreshers for sanitation and personnel practices.
  • Your responsibilities under the law
  • The top 483 - Inspectional Observations and how to avoid them
  •  How to prep for an FDA Establishment Inspection 
  • A step-by-step review of the inspection process and the new Compliance Program for dietary supplements
  • A review of the Food Safety Modernization Act, including PCQI and FSVP


“The Three day training will include the following topics:

State of the Industry
  • Statistics
  • Trends and regulatory actions
  • Top FDA 483 Observations
  • New and evolving regulations
Covid Overview in the Dietary Supplements Industry
The DS Regulations
  • Food, Drug, and Cosmetic Act
  • Investigations Operations Manual
  • 21 CFR Part 111 (GMPs)
  • Compliance Program
  • Online references
Prepping for the Establishment Inspection (EI)
Pre-inspection activities
FDA 482 and credentials
Attachment E and raw materials of special interest
Facility Registration

The Establishment Inspection
  • History of the company with FDA
  • Interstate and jurisdiction
  • Marketing, including labels, labeling, website and finished product literature review
  • Claims (FDA & FTC)
  • Individual responsibilities
  • Training and training documents
​The Establishment Inspection (con't)
  • Manufacturing, including plant and grounds, equipment, personnel, quarantine & storage
  • Request for “Written Procedures”
  • Manufacturing: Identifying risks, process controls, employee practices, water systems and manufacturing codes
  • Individual responsibilities
  • Training and training documents
  • Manufacturing, including plant and grounds, equipment, personnel, quarantine & storage
  • Understanding the quality control section in the Compliance Program
  • Pest Control Programs
  • Complaints
  • Recall procedures
  • FDA Product Review: Documentation, specs and release criteria
  • End of the Establishment Inspection and Close-out Meeting
Preparing a Written Response to an FDA 483
FDA Establishment Inspection classifications and post-EI activities
Food Safety Modernization Act (FSMA)
Foreign Supplier Verification Program (FSVP)
Preventive Control Qualified Individuals (PCQI)
Register today by contacting Linda O’Dea, Regulatory and Event Coordinator, linda@unpa.com. ​
Registration: Regular Price $1,799. UNPA Member: $1,499 (Discounts available for multiple participants)

​Check out the full schedule of courses.  
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