 The UNPA January/February virtual training courses have been scheduled. We’re excited to announce a two day GMP Inspection Training course and the addition of a February Preventive Controls for Human Food blended course. Both courses 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.  January 27-28, 2021 COURSE DESCRIPTION The GMP 111 two-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. Over the course of these two 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:
Register today by contacting Linda O’Dea, Regulatory and Event Coordinator, linda@unpa.com. Registration: Regular Price $1,799. UNPA Member: $1,499  February 23-25, 2021 COURSE DESCRIPTION The Preventive Controls for Human Food (PCQI) virtual blended course, presented by United Natural Products Alliance, is scheduled for February 23-25, 2021. This three day/four hours per day course is intended to ensure safe manufacturing/processing, packing and holding of food products for human consumption in the United States. The regulation requires that certain activities must be completed by a Preventive Controls Qualified Individual (PCQI) who has successfully completed training in the development and application of risk-based preventive controls. This course developed by the FSPCA is the “standardized curriculum” recognized by the FDA and meets the requirements for a “preventive controls qualified individual” (PCQI). “A Preventive controls qualified individual “means a qualified individual who has successfully completed training in the development and application of risk-based preventive controls at least equivalent to that received under a standardized curriculum recognized as adequate by FDA or is otherwise qualified through job experience to develop and apply a food safety system.” This is the definition is from Current Good Manufacturing Practice, Hazard Analysis, and Risk-based Preventive Controls for Human Food regulation § 117.3 and the Current Good Manufacturing Practice, Hazard Analysis, and Risk-based Preventive Controls for Food for Animals regulation § 507.3.” Food Safety Preventive Controls Alliance “Under the Preventive Controls for Human Food rule, the responsibilities of a “preventive controls qualified individual” include to oversee or perform 1) preparation of the Food Safety Plan, 2) validation of the preventive controls, 3) records review, 4) reanalysis of the Food Safety Plan, and other activities as appropriate to the food. See § 117.180 and 507.53 for more details.” Food Safety Preventive Controls Alliance The PCHF rule applies to dietary supplement and natural products if:
Upon successful completion of this FSPCA course you will receive your PCQI certificate. This UNPA course will provide tools and insight to help you to interpret and implement this new Food Safety Modernization Act (FSMA) rule within your dietary supplement business. Upon completion you will have the skills and knowledge to:
VIRTUAL BLENDED COURSE The course is designed as a two-part course. Part 1 Part 1 is an online eLearning including 16 self-paced modules of FSPCA curriculum.
Part 2 The February 23-25, 2021 course will run from 8:00 am to 12:30 pm MST. As a participant you will receive Ms. Pavlick’s vast knowledge of the natural products industry. At the end of the course you will be able to:
Register today by contacting Linda O’Dea, Regulatory and Event Coordinator, linda@unpa.com. Registration: Regular Price $1,799. UNPA Member: $1,499 Comments are closed.
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