InstructorRoyed Training
TypeOnline Course
Price$390 USD / 21500 INR.
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dietary supplement regulatory affairs

Introduction

Course Outline

Who should attend

Course Type

Course Duration

Eligibility

Certification

Features

About Dietary Supplement

Related Courses

dietary supplement regulation

This online dietary supplement regulatory affairs course provides understanding of dietary supplement regulation, safety, new dietary ingredient notification and compliance process.

Advance Certification is designed to create an effective Regulatory Affairs Manager for Dietary Supplement, Food Supplement and Nutraceutical Industry. Dietary Supplement Regulatory Affairs training gives practical knowledge and real life job simulation. Course focuses on how regulatory professionals work in a company and understanding of key responsibilities and job functions.

At Royed, we also have advanced certification in food regulatory affairs, which covers dietary supplement regulatory affairs training.

In these online self-paced modules, participants will be understanding about the food regulation and commercialization process in detail. Therefore, it is easy and convenient to access. Course can be accessed 24×7, across anywhere.

The course trains the candidate on new dietary ingredient premarket notification, safety and compliance management process. Moreover, Course covers fundamentals to advance learning on dietary supplement regulation, registration and strategic management process. Above all, this course features regulatory affairs strategic planning for dietary supplement.

  • Course Code: RYD-107
  • Course Title: Advanced Certification in Dietary Supplement Regulatory Affairs (ACDSRA)
  • Nature of course: Online, self paced learning
  • Overview of the Food Industry. Introduction to dietary supplement regulation and registration requirements. 
  • Development and Commercialization of new dietary ingredient. Understanding of the dietary supplement Regulatory Cycle.   
  • Dietary supplement Good Manufacturing Practices. All different sections and modules. Detailed understanding on food manufacturing standard development. Audit of dietary supplement manufacturing plants. Data Integrity and Warning Letter handling training. Recall Management Process. 
  • Food safety Management Process. 
  • Documentation for launch of a dietary supplement and regulatory filing in US, Europe, UK, India, Canada, Japan, GCC, African Region. 
  • New Dietary Ingredient Master File Preparation – Specific Formats for Regulatory Bodies. 
  • Dietary Supplements and Regulations | Premarket activities | labeling requirements | Claims, Approval requirements | Manufacturing Requirements
  • Dietary Supplement Product International Business Management, export documentation. 
  • Launching commercialization process and involvement of regulatory works. 

Who should attend this Food Regulatory Affairs Certification Course? 

  • Those who are in dietary supplement regulatory affairs and related departments.
  • Professionals from dietary supplement product marketing organizations .
  • Food scientist who requires detailed understanding of the dietary supplement regulatory and management process.
  • Fresher or beginners, Those who want to make a career in the dietary supplement makers and marketer’s regulatory department.

Online distance learning course. So, course can be accessed online across anywhere 24×7.

1 Month.

Any body who wants to acquire food regulatory affairs competency should attend the course.

Certificate will be provided at the end of the successful completion of the course

  • Orientation to job related practical aspects of the food regulatory managers, is covered in this course extensively.
  • Simulation to real life working in the regulatory affairs department. Hence it helps to enhance the regulatory strategic decision making.
  • Advance training on food registration requirements for various regulatory bodies.
  • Access to Case Studies to learn about food regulation and registration.

Few of the similar courses

What is dietary supplement?

A dietary supplement is a product that is intended to supplement the diet and provide nutrients that may be missing or insufficient in a person’s daily food intake. Dietary supplements can come in various forms, such as capsules, tablets, powders, liquids, and gummies. They may contain vitamins, minerals, amino acids, herbs, botanicals, or other substances that are intended to promote health or improve nutritional status.

It is important to note that dietary supplements are not meant to replace a healthy and balanced diet, but rather to supplement it. They are also not intended to treat, cure, or prevent any disease, and should not be used as a substitute for prescribed medication without consulting a healthcare provider. It is always recommended to speak with a healthcare professional before starting any new dietary supplement.

Who regulates dietary supplement in US ?

FDA regulates both finished dietary supplement products and dietary ingredients. FDA regulates dietary supplements under a different set of regulations than those covering “conventional” foods and drug products. Under the Dietary Supplement Health and Education Act of 1994 (DSHEA):

  • Manufacturers and distributors of dietary supplements and dietary ingredients are prohibited from marketing products that are adulterated or misbranded.  That means that these firms are responsible for evaluating the safety and labeling of their products before marketing to ensure that they meet all the requirements of the Federal Food, Drug, and Cosmetic Act as amended by DSHEA and FDA regulations.
  • FDA has the authority to take action against any adulterated or misbranded dietary supplement product after it reaches the market.
Section 1R&D, Commercialization of Food.
Lecture 1Introduction to Food Regulations 
Lecture 2Certifications for Food Business | Understanding on various types of certification
Lecture 3Regulatory Affairs functions in food business 
Lecture 4New Food Product Development | Food Commercialization Process | NPD and Regulatory Activities 
Lecture 5Introduction to Food Hygiene and Safety
Lecture 6Food | Definition| Classification| Unsafe and Hazardous foods 
Lecture 7Principle of Safe Food Preparation 
Lecture 8Food Control | Important Principles | Component of food control system | Responsibility for food controls 
Lecture 9Food Control - Communication and Educations 
Lecture 10Food Law | Overview of EU regulations 
Lecture 11Regulatory Agencies of different countries 
Lecture 12Dietary Supplements and Regulations | Premarket activities | labeling requirements | Claims, Approval requirements | Manufacturing Requirements 
Lecture 13Dietary Supplement is Food?
Lecture 14Nutritional Supplement | Key Facts Regarding Nutrition Supplement
Section 2Registration and Regulation of Food Supplement | Dietary Supplement | Nutraceutical Regulation
Lecture 15Dietary Supplement (DS) | Nutraceutical | NHPs | Functional Food | Phytochemicals | Multivitamin - Mineral Supplement - Differentiations, Similarities, Regulation requirement assessment
Lecture 16Dietary Supplement Products & Ingredients | New Dietary Ingredients (NDIs) 
Lecture 17NDIs Premarket notification 
Lecture 18Case Studies - NDI designation Process
Lecture 19NDI – Notification Requirements and Adulteration Standard
Lecture 20Developing Safety Profile for New Dietary Ingredient | Dietary Supplement Safety Narratives | common error about margin of safety in NDI notifications
Lecture 21NOEL | NOAEL 
Lecture 22Safety Factor Determination based on Animal Toxicity Study 
Lecture 23Margin of Safety | Safety factor | Safety Discussion in NDI notification
Lecture 24EDI | ADI 
Lecture 25Case Study: NDI notification and   generally recognized as safe (GRAS)
Lecture 2675 Day Premarket NDI Notification Documentation | Review from Real Life Submission | Different Sections | Hands on Documentation Training
Lecture 2775 Day Premarket NDIN Submission List
Lecture 28FDA response letter - 75 Day Premarket NDI Notification | Actions
Section 3Good Manufacturing Practices for Dietary Supplement Manufacturer
Lecture 29Premises & Plant Layout Designing
Lecture 30Sanitation and Hygiene
Lecture 31Equipment Module
Lecture 32Production Module
Lecture 33Documentation
Lecture 34Quality Control
Lecture 35Product Complaint
Lecture 36Storage Module
Section 4Quality Management System of Dietary Supplement Manufacturer
Lecture 37Food Product - Risk Management - Introduction 
Lecture 38ISO Certification and audits
Lecture 39BRCGS
Lecture 40ISO 22000 
Lecture 41FSSC 22000
Lecture 42PrimusGFS
Lecture 43NON GMO
Lecture 44The Plant-Based Certification Program - PBS
Lecture 45HALAL Certifications
Lecture 46Other Feed Safety Certifications
Section 5Documentation for launch of dietary supplement
Lecture 47Food Dossier
Lecture 48Novel Food Approval Process in India
Lecture 49EU Food Authorization
Lecture 50Novel Food
Lecture 51Pre-Market Submission Management Process for Food Additives, Infant Formulas and Novel Foods
Section 6Food / Dietary Supplement Labeling
Lecture 52Introduction to Food Labeling 
Lecture 53FDA Labeling Requirements
Lecture 54Label claim for conventional food and dietary supplement
Lecture 55Food Label | PDP | Information Panel designing | Compliance from Regulatory Perspective
Lecture 56Net Quantity of content statement 
Lecture 57Expiration Dating | Best Before | Use By | Sell By Dates
Lecture 58Gluten Free Labeling of Foods
Lecture 59Traffic Light Labels | How to design | Reference Intake 
Lecture 60Daily Value (DV) | % Daily Value (% DV)
Section 7Shelf Life Stability Testing for Dietary Supplement
Lecture 61Food Shelf Life Stability Testing | Stability Studies | Expiration Dating
Lecture 62Stability Study of Processed Food  
Lecture 63Health Supplement - Stability Study | Study Design - Batch Selection | Testing Frequency | Reduced Batches | Storage Condition | Container Closure System 
Lecture 64Climate Zone
Lecture 65Stability Zone Finder
Lecture 66Accelerated and intermediate testing conditions
Lecture 67Long Term Stability Study
Lecture 68Stability Data Sheet
Lecture 69Testing Frequency
Lecture 70Bracketing
Lecture 71Matrixing
Section 8Export Documentation and International Business
Lecture 72Introduction of Export Documentation | Understanding of important terminologies
Lecture 73Proforma Invoice - Detailed understanding how to prepare Proforma Invoice
Lecture 74Export Contract | Importance | Considerations | Things to include in Export Contract
Lecture 75Commercial Invoice | Importance | Differences with Proforma Invoice 
Lecture 76Custom House Agent | Role, Responsibilities, How they work | Freight Forwarder - Difference with CHA | Case Study
Lecture 77Letter of Credit | How it works | Different types of LC | LC terms and conditions | Sight LC | Case Studies
Lecture 78Bank Guarantee (BG) | How BG works | Differences between BG and LC | Applicability of BG
Lecture 79LC Discounting | How it works | How to calculate the LC discounting
Lecture 80Packing List | Importance | Things to include in packing list
Lecture 81Incoterms | 2020 Incoterms | Practical understanding on different types of Incoterms | Choosing the right incoterm
Lecture 82Logical selection of Incoterms | Landing in right incoterms for your business
Lecture 83Pre-shipment Certificate | COO |CVO| Fumigation Certificate | Preshipment Inspection Certificate | Certificate of Health
Lecture 84Transport Documents | Bill of Lading | Different Types of Bill of Lading | Airway Bill
Lecture 85Airfreight calculation | Gross Weight | Tare Weight | New Weight | Volumetric Calculation | Freight rate calculation
Section 9Inspection and Audit of Dietary Supplement Manufacturing Plant
Lecture 86Establishment Inspection Report | 483 Observations | USFDA Warning Letter | Handling of FDA inspection | Closing of Warning Letter 
Lecture 87Data Integrity
Lecture 88Electronic Batch Record for effective compliance management | Key Understanding | Functionalities | Importance in managing data integrity
Lecture 89RTQs | Response to Queries | How to handle Regulatory Queries