InstructorRoyed Training
TypeOnline Course
Student Enrolled1
Price$690 USD / 48300 INR.
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Food regulatory affairs course

Introduction

Course Outline

Who should attend

Course Type

Course Duration

Eligibility

Certification

Features

Related Courses

About RA

Food regulatory affairs course

This online food regulatory affairs course provides understanding of food regulation, safety, registration and compliance process.

Advance Certification is designed to create an effective Regulatory Affairs Manager for Food, Food Supplement and Nutraceutical Industry. Food 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 1 month advanced certificate course in Food Regulatory Affairs.

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 novel food development, regulatory approval, compliance management process will be covered in phased manner for easy understanding. Moreover, Course covers fundamentals to advance learning on food development, regulation, registration and strategic management process. Above all, this course features regulatory affairs strategic planning.

Course Code: RYD-097

Course Title: PG Certification in Food Regulatory Affairs 

Nature of course: Online, self paced learning

  • Overview of the Food Industry. Introduction to Food Regulatory Affairs. Classification of Foods. Regulatory authorities for the food industry.
  • Development and Commercialization of Food. Understanding of the Food Regulatory Cycle.   
  • Food Good Manufacturing Practices. All different sections and modules. Detailed understanding on food manufacturing standard development. Audit of plants. Data Integrity and Warning Letter handling training. Recall Management Process. 
  • Food safety Management Process. 
  • Documentation for launch of a new food product and regulatory filing in US, Europe, UK, India, Canada, Japan, GCC, African Region. 
  • Novel Food Product Dossier preparation – Specific Formats for Regulatory Bodies 
  • Food Industry Intellectual Property Right Management. IPR, Patents, Copyrights and Trademarking Process. 
  • Food 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 food regulatory affairs and related departments.
  • Professionals from food product marketing organizations .
  • Food scientist who requires detailed understanding of the food regulatory and management process.
  • Fresher or beginners, Those who want to make a career in the food regulatory department.

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

1 Year.

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

Career in Food Regulatory Affairs

A career in Food Regulatory Affairs is very challenging, but highly rewarding. In fact, it opens up lot of opportunities for professionals. But the regulatory job covers a variety of disciplines. For instance, regulatory professional involved involved in novel food product’s regulatory submission, compliance, testing of the food products, quality assurance, safety, vigilance process. Hence, they should have comprehensive knowledge on various topics. For example, novel food development process, regulatory approval process, quality assurance, quality control, formulation, etc. In fact, more the knowledge, it will be more beneficial, which will help them to reach a greater height in organization hierarchy.

Safety of the food is a concern in food business

The Food, food supplement and nutraceutical industry is growing at a rapid pace. But there is a rising concern over the safety and efficacy. Major objective of the regulatory department to maintain safety and efficacy of the foods products which are in market. Therefore in order to  maintain safety and efficacy of foods, regulatory agencies all over the world are imposing number of regulations. These regulations are evolving and changing every other day. Hence, regulatory professionals must have thorough knowledge about the updated regulations. Sound regulatory knowledge helps them to take strategic decision effectively.  Therefore, this has resulted in creation of regulatory department with certified regulatory affairs professionals. Above all, it help companies to meet these requirements with ease.

About regulatory affairs job>> Learn here

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 
Section 2Intellectual Property Management for Food Industry
Lecture 12Introduction to intellectual Property Management
Lecture 13Introduction to Patent 
Lecture 14Understanding on Patent System
Lecture 15Patent Grant and Managing Patent Filing Procedure
Lecture 16Scope of Patentability 
Lecture 17Patent Grant and Handling Process in India 
Lecture 18Stages of Patent Grant Procedure
Lecture 19Patent search in Indian Patent Office
Lecture 20Differences in US and European Patent
Lecture 21Patent Claim | Types of Patent Claims 
Lecture 22Terminologies related to patent, trademark, copyright and licensing 
Lecture 23Patent Infringement
Lecture 24Introduction to Trademark | Trademark filing procedure
Lecture 25Trademark Searching Process | EUIPO Searching | USPTO Searching | IPINDIA Searching 
Lecture 26Trademark Infringement | Passing off | Practical Cases
Lecture 27Trademark Classes | How to search the right trademark class for for filing trademark application
Section 3Food Good Manufacturing Practices
Lecture 28Premises & Plant Layout Designing
Lecture 29Sanitation and Hygiene
Lecture 30Equipment Module
Lecture 31Production Module
Lecture 32Documentation
Lecture 33Quality Control
Lecture 34Product Complaint
Lecture 35Storage Module
Section 4Quality Management System of Food Plant
Lecture 36Food Product - Risk Management - Introduction 
Lecture 37ISO Certification and audits
Lecture 38BRCGS Standards | Importance | Different BRCGS Standards | Certification Steps 
Lecture 39ISO 22000 
Lecture 40FSSC 22000
Lecture 41PrimusGFS
Lecture 42NON GMO
Lecture 43The Plant-Based Certification Program - PBS
Lecture 44HALAL Certifications
Lecture 45Certification for Nutraceutical, Food, Dietary Supplement Plants
Lecture 46Other quality Certifications for Food Businesses 
Section 5Registration and Regulation of Food Supplement | Dietary Supplement | Nutraceutical Regulation
Lecture 47Introduction to Nutraceutical | Functional Food | Dietary Supplement | Health Food | Regulation and Approval Process
Lecture 48Dietary Supplement (DS) | Nutraceutical | NHPs | Functional Food | Phytochemicals | Multivitamin - Mineral Supplement - Differentiations, Similarities, Regulation requirement assessment 
Lecture 49Dietary Supplement Vs. Nutraceuticals | Analysis of terms
Lecture 50Nutraceutical / Dietary Supplement Market Insight | Overall Market Size, dietary supplement market segmentation,  Ingredient wise market share, Dosage Form, Usage and Application Segmentation, End user outlook, distribution channel 
Lecture 51Functional Foods | Definition | Characteristics | Categories | Examples with usages
Lecture 52Functional Foods Master Classification: Understanding of various nutraceutical ingredients, classifications, unique selling points, positioning statements
Lecture 53Nutra Disease Matrix
Lecture 54Nutraceutical Ingredient Master Database
Lecture 55Key Activities for Nutraceutical Product Manufacturing | Checklist | Step by step process planning
Lecture 56Dietary Supplements and Regulations | Premarket activities | labeling requirements | Claims, Approval requirements | Manufacturing Requirements 
Lecture 57Introduction to Nutraceutical | Functional Food | Dietary Supplement | Health Food | Regulation and Approval Process
Lecture 58Nutraceutical Registration in India | FASSI guidelines | Process of FASSI licensing | FAQs 
Lecture 59FASSI Nutraceutical Registration Pathway | Step By Step Planning  
Lecture 60FASSI Novel Food Approval Pathways | Step By Step Planning | Key considerations for novel food designation
Lecture 61FASSI Nutraceutical Class Designation | Practical Examples with reasoning 
Lecture 62Dietary Supplement Products & Ingredients | New Dietary Ingredients (NDIs) 
Lecture 63NDIs Premarket notification 
Lecture 64Case Studies - NDI designation Process
Lecture 65NDI – Notification Requirements and Adulteration Standard
Lecture 66Developing Safety Profile for New Dietary Ingredient | Dietary Supplement Safety Narratives | common error about margin of safety in NDI notifications
Lecture 67NOEL | NOAEL 
Lecture 68Safety Factor Determination based on Animal Toxicity Study 
Lecture 69Margin of Safety | Safety factor | Safety Discussion in NDI notification
Lecture 70EDI | ADI 
Lecture 71Case Study: NDI notification and   generally recognized as safe (GRAS)
Lecture 72NDIN Safety Information Package | Documentation | Different Sections | Templates 
Lecture 73FDA response to NDIN | Post submission action plan 
Lecture 74NDIN Case Studies and Discussion 
Lecture 75NDIN Master File
Lecture 76GRAS : Detailed Understanding | Regulatory Significance |  [GRAS 1.1]
Lecture 77GRAS Determination Process [GRAS 1.2]
Lecture 78GRAS Determination Checklist [GRAS 1.3]
Lecture 79GRAS Usage Guidance [GRAS1.5]
Lecture 80GRAS Review Test [GRAS1.4]
Lecture 81If Not GRAS Pathway [GRAS1.6]
Lecture 82FAP Vs. DSHEA-NDI Pathways | Advanced Comparison
Section 6Documentation for launch of a new food product and regulatory filing
Lecture 83Food Dossier
Lecture 84Novel Food Approval Process in India
Lecture 85EU Food Authorization
Lecture 86Novel Food
Lecture 87Pre-Market Submission Management Process for Food Additives, Infant Formulas and Novel Foods
Section 7Food Labeling
Lecture 88Introduction to Food Labeling 
Lecture 89FDA Labeling Requirements
Lecture 90Label claim for conventional food and dietary supplement
Lecture 91Food Label | PDP | Information Panel designing | Compliance from Regulatory Perspective
Lecture 92Net Quantity of content statement 
Lecture 93Expiration Dating | Best Before | Use By | Sell By Dates
Lecture 94Gluten Free Labeling of Foods
Lecture 95Traffic Light Labels | How to design | Reference Intake 
Lecture 96Daily Value (DV) | % Daily Value (% DV)
Section 8Food Shelf Life Stability Testing
Lecture 97Food Shelf Life Stability Testing | Stability Studies | Expiration Dating
Lecture 98Stability Study of Processed Food  
Lecture 99Health Supplement - Stability Study | Study Design - Batch Selection | Testing Frequency | Reduced Batches | Storage Condition | Container Closure System 
Lecture 100Climate Zone
Lecture 101Stability Zone Finder
Lecture 102Accelerated and intermediate testing conditions
Lecture 103Long Term Stability Study
Lecture 104Stability Data Sheet
Lecture 105Testing Frequency
Lecture 106Bracketing
Lecture 107Matrixing
Section 9Export Documentation and International Business
Lecture 108Introduction of Export Documentation | Understanding of important terminologies
Lecture 109Proforma Invoice - Detailed understanding how to prepare Proforma Invoice
Lecture 110Export Contract | Importance | Considerations | Things to include in Export Contract
Lecture 111Commercial Invoice | Importance | Differences with Proforma Invoice 
Lecture 112Custom House Agent | Role, Responsibilities, How they work | Freight Forwarder - Difference with CHA | Case Study
Lecture 113Letter of Credit | How it works | Different types of LC | LC terms and conditions | Sight LC | Case Studies
Lecture 114Bank Guarantee (BG) | How BG works | Differences between BG and LC | Applicability of BG
Lecture 115LC Discounting | How it works | How to calculate the LC discounting
Lecture 116Packing List | Importance | Things to include in packing list
Lecture 117Incoterms | 2020 Incoterms | Practical understanding on different types of Incoterms | Choosing the right incoterm
Lecture 118Logical selection of Incoterms | Landing in right incoterms for your business
Lecture 119Pre-shipment Certificate | COO |CVO| Fumigation Certificate | Preshipment Inspection Certificate | Certificate of Health
Lecture 120Transport Documents | Bill of Lading | Different Types of Bill of Lading | Airway Bill
Lecture 121Airfreight calculation | Gross Weight | Tare Weight | New Weight | Volumetric Calculation | Freight rate calculation
Section 10Inspection and Audit of Food Plant
Lecture 122Establishment Inspection Report | 483 Observations | USFDA Warning Letter | Handling of FDA inspection | Closing of Warning Letter 
Lecture 123Data Integrity
Lecture 124Electronic Batch Record for effective compliance management | Key Understanding | Functionalities | Importance in managing data integrity
Lecture 125RTQs | Response to Queries | How to handle Regulatory Queries Â