Good Manufacturing Practices (GMP) Inspection Training

Dates:
June 15-16, 2022 (Virtual)

Daily Virtual Schedule:
Day 1: 9am-1:30pm MST
Day 2: 9am-1:30pm MST

Price:
UNPA Member Rate: $1,550
Regular Rate: $1,850
Discounts available for multiple participants

Register:
Contact Linda O’Dea, Regulatory and Event Coordinator, Linda@unpa.com

 

Course Description

The GMP 111 two1/2 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.​

larisa pavlick unpa united natural products alliance staff photo headshot bioAbout 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 one of the only instructors 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).

View Larisa’s full bio >>

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 two 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
  • 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:
Contact Linda O’Dea, Regulatory and Event Coordinator, linda@unpa.com

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