InstructorRoyed Training
TypeOnline Course
(1 ratings)
Price$490 / 34300 INR.
Buy NowBook Now
Loading
Loading
food regulatory affairs training course

Introduction

Course Outline

Who should attend

Features

Related Courses

About Food 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 year PG Certification in Food Regulatory Affair course.

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 Snapshots

  • Course Code: RYD-062
  • Title of the course: Advanced Certification in Food Regulatory Affairs (ACFRA)
  • Nature of course: Online, self paced learning
  • Duration of the course: 1 Month
  • Eligibility: Any body who wants to acquire food regulatory affairs competency should attend the course.
  • Certification: Certificate will be provided at the end of the successful completion of the course.

  • 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. 
  • Dietary Supplements and Regulations | Premarket activities | labeling requirements | Claims, Approval requirements | Manufacturing Requirements
  • 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.
  • 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 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 2Intellectual Property Management for Food Industry
Lecture 15Introduction to intellectual Property Management
Lecture 16Introduction to Patent 
Lecture 17Understanding on Patent System
Lecture 18Patent Grant and Managing Patent Filing Procedure
Lecture 19Scope of Patentability 
Lecture 20Patent Grant and Handling Process in India 
Lecture 21Stages of Patent Grant Procedure
Lecture 22Patent search in Indian Patent Office
Lecture 23Differences in US and European Patent
Lecture 24Patent Claim | Types of Patent Claims 
Lecture 25Terminologies related to patent, trademark, copyright and licensing 
Lecture 26Patent Infringement
Lecture 27Introduction to Trademark | Trademark filing procedure
Lecture 28Trademark Searching Process | EUIPO Searching | USPTO Searching | IPINDIA Searching 
Lecture 29Trademark Infringement | Passing off | Practical Cases
Lecture 30Trademark Classes | How to search the right trademark class for for filing trademark application
Section 3Food Good Manufacturing Practices
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 Food Plant
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 5Registration and Regulation of Food Supplement | Dietary Supplement | Nutraceutical Regulation
Lecture 49Dietary Supplement (DS) | Nutraceutical | NHPs | Functional Food | Phytochemicals | Multivitamin - Mineral Supplement - Differentiations, Similarities, Regulation requirement assessment
Lecture 50Dietary Supplement Products & Ingredients | New Dietary Ingredients (NDIs) 
Lecture 51NDIs Premarket notification 
Lecture 52Case Studies - NDI designation Process
Lecture 53Case Studies - NDI designation Process
Lecture 54Developing Safety Profile for New Dietary Ingredient | Dietary Supplement Safety Narratives | common error about margin of safety in NDI notifications
Lecture 55NOEL | NOAEL 
Lecture 56Safety Factor Determination based on Animal Toxicity Study 
Lecture 57Margin of Safety | Safety factor | Safety Discussion in NDI notification | EDI | ADI | Calculation | Case Studies
Lecture 58PKPD - ADME Study | PK-PD trial | Understanding PKPD from regulatory perspective
Lecture 59NDI notification and generally recognized as safe (GRAS)
Lecture 60NDIN Dossier | Notification Documentation | Different Sections 
Lecture 61NDIN Safety Information Package | Documentation | Different Sections | Templates 
Lecture 62FDA response to NDIN | Post submission action plan 
Lecture 63NDIN Case Studies and Discussion 
Lecture 64NDIN Master File
Section 6Documentation for launch of a new food product and regulatory filing
Section 7Food Labeling
Lecture 66Introduction to Food Labeling 
Lecture 67FDA Labeling Requirements
Lecture 68Label claim for conventional food and dietary supplement
Lecture 69Food Label | PDP | Information Panel designing | Compliance from Regulatory Perspective
Lecture 70Net Quantity of content statement 
Lecture 71Expiration Dating | Best Before | Use By | Sell By Dates
Lecture 72Gluten Free Labeling of Foods
Lecture 73Traffic Light Labels | How to design | Reference Intake 
Lecture 74Daily Value (DV) | % Daily Value (% DV)
Section 8Food Shelf Life Stability Testing
Lecture 75Food Shelf Life Stability Testing | Stability Studies | Expiration Dating
Lecture 76Stability Study of Processed Food  
Lecture 77Health Supplement - Stability Study | Study Design - Batch Selection | Testing Frequency | Reduced Batches | Storage Condition | Container Closure System 
Lecture 78Climate Zone
Lecture 79Stability Zone Finder
Lecture 80Accelerated and intermediate testing conditions
Lecture 81Long Term Stability Study
Lecture 82Stability Data Sheet
Lecture 83Testing Frequency
Lecture 84Bracketing
Lecture 85Matrixing
Section 9Export Documentation and International Business
Lecture 86Introduction of Export Documentation | Understanding of important terminologies
Lecture 87Proforma Invoice - Detailed understanding how to prepare Proforma Invoice
Lecture 88Export Contract | Importance | Considerations | Things to include in Export Contract
Lecture 89Commercial Invoice | Importance | Differences with Proforma Invoice 
Lecture 90Custom House Agent | Role, Responsibilities, How they work | Freight Forwarder - Difference with CHA | Case Study
Lecture 91Letter of Credit | How it works | Different types of LC | LC terms and conditions | Sight LC | Case Studies
Lecture 92Bank Guarantee (BG) | How BG works | Differences between BG and LC | Applicability of BG
Lecture 93LC Discounting | How it works | How to calculate the LC discounting
Lecture 94Packing List | Importance | Things to include in packing list
Lecture 95Incoterms | 2020 Incoterms | Practical understanding on different types of Incoterms | Choosing the right incoterm
Lecture 96Logical selection of Incoterms | Landing in right incoterms for your business
Lecture 97Pre-shipment Certificate | COO |CVO| Fumigation Certificate | Preshipment Inspection Certificate | Certificate of Health
Lecture 98Transport Documents | Bill of Lading | Different Types of Bill of Lading | Airway Bill
Lecture 99Airfreight calculation | Gross Weight | Tare Weight | New Weight | Volumetric Calculation | Freight rate calculation
Section 10Inspection and Audit of Food Plant
Lecture 100Establishment Inspection Report | 483 Observations | USFDA Warning Letter | Handling of FDA inspection | Closing of Warning Letter 
Lecture 101Data Integrity
Lecture 102Electronic Batch Record for effective compliance management | Key Understanding | Functionalities | Importance in managing data integrity
Lecture 103RTQs | Response to Queries | How to handle Regulatory Queries