InstructorRoyed Training
TypeOnline Course
Student Enrolled1
Price$490 USD / 27500 INR.
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dietary supplement regulatory affairs course

Introduction

Course Outline

Who should attend

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 Snapshot

  • Course Code: RYD-107
  • Course Title: Advanced Certification in Dietary Supplement Regulatory Affairs (ACDSRA)
  • Nature of course: Online, self paced learning. So, course can be accessed online across anywhere 24×7.
  • Duration of the course : 1 Month
  • Eligibility: Any body who wants to acquire dietary supplement regulatory affairs competency should attend the course.
  • Course Certification: Certificate will be provided at the end of the successful completion of the course.
  • 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.
  • 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 Law | Overview of EU regulations 
Lecture 10Regulatory Agencies of different countries 
Lecture 11Dietary Supplements and Regulations | Premarket activities | labeling requirements | Claims, Approval requirements | Manufacturing Requirements 
Lecture 12Introduction to Nutraceutical | Functional Food | Dietary Supplement | Health Food | Regulation and Approval Process
Lecture 13Dietary Supplement Vs. Nutraceuticals | Analysis of terms
Lecture 14Nutraceutical Product Classification | Nutraceutical Product Portfolio Management
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 | EDI | ADI | Calculations | Case Studies
Lecture 24PKPD - ADME Study | PK-PD trial | Understanding PKPD from regulatory perspective
Lecture 25NDI notification and  generally recognized as safe (GRAS)
Lecture 26NDIN Dossier | Notification Documentation | Different Sections 
Lecture 27NDIN Safety Information Package | Documentation | Different Sections | Templates 
Lecture 28FDA response to NDIN | Post submission action plan 
Lecture 29NDIN Case Studies and Discussion 
Lecture 30NDIN Master File
Section 3Good Manufacturing Practices for Dietary Supplement Manufacturer
Lecture 31Premises & Plant Layout Designing
Lecture 32Sanitation and Hygiene
Lecture 33Equipment Module
Lecture 34Production Module
Lecture 35Documentation
Lecture 36Quality Control
Lecture 37Product Complaint
Lecture 38Storage Module
Section 4Quality Management System of Dietary Supplement Manufacturer
Lecture 39Food Product - Risk Management - Introduction 
Lecture 40ISO Certification and audits
Lecture 41BRCGS
Lecture 42ISO 22000 
Lecture 43FSSC 22000
Lecture 44PrimusGFS
Lecture 45NON GMO
Lecture 46The Plant-Based Certification Program - PBS
Lecture 47HALAL Certifications
Lecture 48Other Feed Safety Certifications
Section 5Documentation for launch of dietary supplement
Lecture 49Food Dossier
Lecture 50Novel Food Approval Process in India
Lecture 51EU Food Authorization
Lecture 52Novel Food
Lecture 53Pre-Market Submission Management Process for Food Additives, Infant Formulas and Novel Foods
Section 6Food / Dietary Supplement Labeling
Lecture 54Introduction to Food Labeling 
Lecture 55FDA Labeling Requirements
Lecture 56Label claim for conventional food and dietary supplement
Lecture 57Food Label | PDP | Information Panel designing | Compliance from Regulatory Perspective
Lecture 58Net Quantity of content statement 
Lecture 59Expiration Dating | Best Before | Use By | Sell By Dates
Lecture 60Gluten Free Labeling of Foods
Lecture 61Traffic Light Labels | How to design | Reference Intake 
Lecture 62Daily Value (DV) | % Daily Value (% DV)
Section 7Shelf Life Stability Testing for Dietary Supplement
Lecture 63Food Shelf Life Stability Testing | Stability Studies | Expiration Dating
Lecture 64Stability Study of Processed Food  
Lecture 65Health Supplement - Stability Study | Study Design - Batch Selection | Testing Frequency | Reduced Batches | Storage Condition | Container Closure System 
Lecture 66Climate Zone
Lecture 67Stability Zone Finder
Lecture 68Accelerated and intermediate testing conditions
Lecture 69Long Term Stability Study
Lecture 70Stability Data Sheet
Lecture 71Testing Frequency
Lecture 72Bracketing
Lecture 73Matrixing
Section 8Export Documentation and International Business
Lecture 74Introduction of Export Documentation | Understanding of important terminologies
Lecture 75Proforma Invoice - Detailed understanding how to prepare Proforma Invoice
Lecture 76Export Contract | Importance | Considerations | Things to include in Export Contract
Lecture 77Commercial Invoice | Importance | Differences with Proforma Invoice 
Lecture 78Custom House Agent | Role, Responsibilities, How they work | Freight Forwarder - Difference with CHA | Case Study
Lecture 79Letter of Credit | How it works | Different types of LC | LC terms and conditions | Sight LC | Case Studies
Lecture 80Bank Guarantee (BG) | How BG works | Differences between BG and LC | Applicability of BG
Lecture 81LC Discounting | How it works | How to calculate the LC discounting
Lecture 82Packing List | Importance | Things to include in packing list
Lecture 83Incoterms | 2020 Incoterms | Practical understanding on different types of Incoterms | Choosing the right incoterm
Lecture 84Logical selection of Incoterms | Landing in right incoterms for your business
Lecture 85Pre-shipment Certificate | COO |CVO| Fumigation Certificate | Preshipment Inspection Certificate | Certificate of Health
Lecture 86Transport Documents | Bill of Lading | Different Types of Bill of Lading | Airway Bill
Lecture 87Airfreight calculation | Gross Weight | Tare Weight | New Weight | Volumetric Calculation | Freight rate calculation
Lecture 88Dietary Supplement Export Documentation Checklist
Section 9Inspection and Audit of Dietary Supplement Manufacturing Plant
Lecture 89Establishment Inspection Report | 483 Observations | USFDA Warning Letter | Handling of FDA inspection | Closing of Warning Letter 
Lecture 90Data Integrity
Lecture 91Electronic Batch Record for effective compliance management | Key Understanding | Functionalities | Importance in managing data integrity
Lecture 92RTQs | Response to Queries | How to handle Regulatory Queries  
Section 10Request for Course Certificate