InstructorRoyed Training
TypeOnline Course
Price$690 USD / 34500 INR.
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pg certification in food regulatory affairs

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
Lecture 39ISO 22000 
Lecture 40FSSC 22000
Lecture 41PrimusGFS
Lecture 42NON GMO
Lecture 43The Plant-Based Certification Program - PBS
Lecture 44HALAL Certifications
Lecture 45Other Feed Safety Certifications
Section 5Registration and Regulation of Food Supplement | Dietary Supplement | Nutraceutical Regulation
Lecture 46Dietary Supplement (DS) | Nutraceutical | NHPs | Functional Food | Phytochemicals | Multivitamin - Mineral Supplement - Differentiations, Similarities, Regulation requirement assessment 
Lecture 47Dietary Supplement Products & Ingredients | New Dietary Ingredients (NDIs) 
Lecture 48NDIs Premarket notification 
Lecture 49Case Studies - NDI designation Process
Lecture 50NDI – Notification Requirements and Adulteration Standard
Lecture 51Developing Safety Profile for New Dietary Ingredient | Dietary Supplement Safety Narratives | common error about margin of safety in NDI notifications
Lecture 52NOEL | NOAEL 
Lecture 53Safety Factor Determination based on Animal Toxicity Study 
Lecture 54Margin of Safety | Safety factor | Safety Discussion in NDI notification
Lecture 55EDI | ADI 
Lecture 56Case Study: NDI notification and   generally recognized as safe (GRAS)
Lecture 5775 Day Premarket NDI Notification Documentation | Review from Real Life Submission | Different Sections | Hands on Documentation Training
Lecture 5875 Day Premarket NDIN Submission List
Lecture 59FDA response letter - 75 Day Premarket NDI Notification | Actions
Section 6Documentation for launch of a new food product and regulatory filing
Lecture 60Food Dossier
Lecture 61Novel Food Approval Process in India
Lecture 62EU Food Authorization
Lecture 63Novel Food
Lecture 64Pre-Market Submission Management Process for Food Additives, Infant Formulas and Novel Foods
Section 7Food Labeling
Lecture 65Introduction to Food Labeling 
Lecture 66FDA Labeling Requirements
Lecture 67Label claim for conventional food and dietary supplement
Lecture 68Food Label | PDP | Information Panel designing | Compliance from Regulatory Perspective
Lecture 69Net Quantity of content statement 
Lecture 70Expiration Dating | Best Before | Use By | Sell By Dates
Lecture 71Gluten Free Labeling of Foods
Lecture 72Traffic Light Labels | How to design | Reference Intake 
Lecture 73Daily Value (DV) | % Daily Value (% DV)
Section 8Food Shelf Life Stability Testing
Lecture 74Food Shelf Life Stability Testing | Stability Studies | Expiration Dating
Lecture 75Stability Study of Processed Food  
Lecture 76Health Supplement - Stability Study | Study Design - Batch Selection | Testing Frequency | Reduced Batches | Storage Condition | Container Closure System 
Lecture 77Climate Zone
Lecture 78Stability Zone Finder
Lecture 79Accelerated and intermediate testing conditions
Lecture 80Long Term Stability Study
Lecture 81Stability Data Sheet
Lecture 82Testing Frequency
Lecture 83Bracketing
Lecture 84Matrixing
Section 9Export Documentation and International Business
Lecture 85Introduction of Export Documentation | Understanding of important terminologies
Lecture 86Proforma Invoice - Detailed understanding how to prepare Proforma Invoice
Lecture 87Export Contract | Importance | Considerations | Things to include in Export Contract
Lecture 88Commercial Invoice | Importance | Differences with Proforma Invoice 
Lecture 89Custom House Agent | Role, Responsibilities, How they work | Freight Forwarder - Difference with CHA | Case Study
Lecture 90Letter of Credit | How it works | Different types of LC | LC terms and conditions | Sight LC | Case Studies
Lecture 91Bank Guarantee (BG) | How BG works | Differences between BG and LC | Applicability of BG
Lecture 92LC Discounting | How it works | How to calculate the LC discounting
Lecture 93Packing List | Importance | Things to include in packing list
Lecture 94Incoterms | 2020 Incoterms | Practical understanding on different types of Incoterms | Choosing the right incoterm
Lecture 95Logical selection of Incoterms | Landing in right incoterms for your business
Lecture 96Pre-shipment Certificate | COO |CVO| Fumigation Certificate | Preshipment Inspection Certificate | Certificate of Health
Lecture 97Transport Documents | Bill of Lading | Different Types of Bill of Lading | Airway Bill
Lecture 98Airfreight calculation | Gross Weight | Tare Weight | New Weight | Volumetric Calculation | Freight rate calculation
Section 10Inspection and Audit of Food Plant
Lecture 99Establishment Inspection Report | 483 Observations | USFDA Warning Letter | Handling of FDA inspection | Closing of Warning Letter 
Lecture 100Data Integrity
Lecture 101Electronic Batch Record for effective compliance management | Key Understanding | Functionalities | Importance in managing data integrity
Lecture 102RTQs | Response to Queries | How to handle Regulatory Queries