Introduction
Course Outline
Who should attend
Course Type
Course Duration
Eligibility
Certification
Features
Related Courses
About RA
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.
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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
Lecture 12Introduction to Global Food Regulatory Affairs | RCSQ Framework
Lecture 13Food Classification – Decision Tree Approach (Global Perspective)
Lecture 14Food Categories & Classification
Lecture 15Food Classification Cases [Real World Examples] | 60 Cases
Lecture 16Medical Foods / FSMP | Novel Foods | Infant and Other Specialized Foods - Classification Exercise
Lecture 17Regulatory vs Compliance vs Quality vs Safety For Food Market Access) | Case Based Understanding
Lecture 18Key Global Regulatory Frameworks Overview | C-W-R-N-P Model
Lecture 19Food Categories & Classification for Regulatory Strategy, Claims & Market Access
Lecture 20Review Test on Food Regulatory Affairs
Lecture 21Global Food Regulatory Landscape Mapping (Region-wise Regulatory Architecture, Authority Roles, and Market Access Logic) | M-A-P-S Framework
Lecture 22Codex Alimentarius Framework - Architecture, Structure, Standards & Operational Logic | S-T-E-P Codex Framework
Lecture 23Decision Matrix: Global vs Local Regulatory Strategy (Food Industry) | Strategic Framework for Multi-Country Food Market Access | S-C-A-L-E Model
Lecture 24Case Study: Regulatory Strategy for Multi-Country Food Product Launch | Regulatory Strategic Planning
Section 2Intellectual Property Management for Food Industry
Lecture 25Introduction to intellectual Property Management
Lecture 26Introduction to Patent
Lecture 27Understanding on Patent System
Lecture 28Patent Grant and Managing Patent Filing Procedure
Lecture 29Scope of Patentability
Lecture 30Patent Grant and Handling Process in India
Lecture 31Stages of Patent Grant Procedure
Lecture 32Patent search in Indian Patent Office
Lecture 33Differences in US and European Patent
Lecture 34Patent Claim | Types of Patent Claims
Lecture 35Terminologies related to patent, trademark, copyright and licensing
Lecture 36Patent Infringement
Lecture 37Introduction to Trademark | Trademark filing procedure
Lecture 38Trademark Searching Process | EUIPO Searching | USPTO Searching | IPINDIA Searching
Lecture 39Trademark Infringement | Passing off | Practical Cases
Lecture 40Trademark Classes | How to search the right trademark class for for filing trademark application
Section 3Food Good Manufacturing Practices
Lecture 41Premises & Plant Layout Designing
Lecture 42Sanitation and Hygiene
Lecture 43Equipment Module
Lecture 44Production Module
Lecture 45Documentation
Lecture 46Quality Control
Lecture 47Product Complaint
Lecture 48Storage Module
Section 4Quality Management System of Food Plant
Lecture 49Food Product - Risk Management - Introduction
Lecture 50Risk-Based Approach in Food Regulation | H-E-R-E Model
Lecture 51BRCGS Standards | Importance | Different BRCGS Standards | Certification Steps
Lecture 52ISO 22000
Lecture 53FSSC 22000
Lecture 54PrimusGFS
Lecture 55NON GMO
Lecture 56The Plant-Based Certification Program - PBS
Lecture 57HALAL Certifications
Lecture 58Certification for Nutraceutical, Food, Dietary Supplement Plants
Lecture 59Other quality Certifications for Food Businesses
Lecture 60ISO and ISO Audits
Section 5Registration and Regulation of Food Supplement | Dietary Supplement | Nutraceutical Regulation
Lecture 61Introduction to Nutraceutical | Functional Food | Dietary Supplement | Health Food | Regulation and Approval Process
Lecture 62Dietary Supplement (DS) | Nutraceutical | NHPs | Functional Food | Phytochemicals | Multivitamin - Mineral Supplement - Differentiations, Similarities, Regulation requirement assessment
Lecture 63Dietary Supplement Vs. Nutraceuticals | Analysis of terms
Lecture 64Nutraceutical / 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 65Functional Foods | Definition | Characteristics | Categories | Examples with usages
Lecture 66Functional Foods Master Classification: Understanding of various nutraceutical ingredients, classifications, unique selling points, positioning statements
Lecture 67Nutra Disease Matrix
Lecture 68Nutraceutical Ingredient Master Database
Lecture 69Key Activities for Nutraceutical Product Manufacturing | Checklist | Step by step process planning
Lecture 70Dietary Supplements and Regulations | Premarket activities | labeling requirements | Claims, Approval requirements | Manufacturing Requirements
Lecture 71Introduction to Nutraceutical | Functional Food | Dietary Supplement | Health Food | Regulation and Approval Process
Lecture 72Nutraceutical Registration in India | FASSI guidelines | Process of FASSI licensing | FAQs
Lecture 73FASSI Nutraceutical Registration Pathway | Step By Step Planning
Lecture 74FASSI Novel Food Approval Pathways | Step By Step Planning | Key considerations for novel food designation
Lecture 75FASSI Nutraceutical Class Designation | Practical Examples with reasoning
Lecture 76Dietary Supplement Products & Ingredients | New Dietary Ingredients (NDIs)
Lecture 77NDIs Premarket notification
Lecture 78Case Studies - NDI designation Process
Lecture 79NDI – Notification Requirements and Adulteration Standard
Lecture 80Developing Safety Profile for New Dietary Ingredient | Dietary Supplement Safety Narratives | common error about margin of safety in NDI notifications
Lecture 81NOEL | NOAEL
Lecture 82Safety Factor Determination based on Animal Toxicity Study
Lecture 83Margin of Safety | Safety factor | Safety Discussion in NDI notification
Lecture 84EDI | ADI
Lecture 85Case Study: NDI notification and generally recognized as safe (GRAS)
Lecture 86NDIN Safety Information Package | Documentation | Different Sections | Templates
Lecture 87FDA response to NDIN | Post submission action plan
Lecture 88NDIN Case Studies and Discussion
Lecture 89NDIN Master File
Lecture 90GRAS : Detailed Understanding | Regulatory Significance | [GRAS 1.1]
Lecture 91GRAS Determination Process [GRAS 1.2]
Lecture 92GRAS Determination Checklist [GRAS 1.3]
Lecture 93GRAS Usage Guidance [GRAS1.5]
Lecture 94GRAS Review Test [GRAS1.4]
Lecture 95If Not GRAS Pathway [GRAS1.6]
Lecture 96FAP Vs. DSHEA-NDI Pathways | Advanced Comparison
Section 6Documentation for launch of a new food product and regulatory filing
Lecture 97Food Dossier
Lecture 98Novel Food Approval Process in India
Lecture 99EU Food Authorization
Lecture 100Novel Food
Lecture 101Pre-Market Submission Management Process for Food Additives, Infant Formulas and Novel Foods
Section 7Food Labeling
Lecture 102Introduction to Food Labeling
Lecture 103FDA Labeling Requirements
Lecture 104Label claim for conventional food and dietary supplement
Lecture 105Food Label | PDP | Information Panel designing | Compliance from Regulatory Perspective
Lecture 106Net Quantity of content statement
Lecture 107Expiration Dating | Best Before | Use By | Sell By Dates
Lecture 108Gluten Free Labeling of Foods
Lecture 109Traffic Light Labels | How to design | Reference Intake
Lecture 110Daily Value (DV) | % Daily Value (% DV)
Section 8Food Shelf Life Stability Testing
Lecture 111Food Shelf Life Stability Testing | Stability Studies | Expiration Dating
Lecture 112Stability Study of Processed Food
Lecture 113Health Supplement - Stability Study | Study Design - Batch Selection | Testing Frequency | Reduced Batches | Storage Condition | Container Closure System
Lecture 114Climate Zone
Lecture 115Stability Zone Finder
Lecture 116Accelerated and intermediate testing conditions
Lecture 117Long Term Stability Study
Lecture 118Stability Data Sheet
Lecture 119Testing Frequency
Lecture 120Bracketing
Lecture 121Matrixing
Section 9Export Documentation and International Business
Lecture 122Introduction of Export Documentation | Understanding of important terminologies
Lecture 123Proforma Invoice - Detailed understanding how to prepare Proforma Invoice
Lecture 124Export Contract | Importance | Considerations | Things to include in Export Contract
Lecture 125Commercial Invoice | Importance | Differences with Proforma Invoice
Lecture 126Custom House Agent | Role, Responsibilities, How they work | Freight Forwarder - Difference with CHA | Case Study
Lecture 127Letter of Credit | How it works | Different types of LC | LC terms and conditions | Sight LC | Case Studies
Lecture 128Bank Guarantee (BG) | How BG works | Differences between BG and LC | Applicability of BG
Lecture 129LC Discounting | How it works | How to calculate the LC discounting
Lecture 130Packing List | Importance | Things to include in packing list
Lecture 131Incoterms | 2020 Incoterms | Practical understanding on different types of Incoterms | Choosing the right incoterm
Lecture 132Logical selection of Incoterms | Landing in right incoterms for your business
Lecture 133Pre-shipment Certificate | COO |CVO| Fumigation Certificate | Preshipment Inspection Certificate | Certificate of Health
Lecture 134Transport Documents | Bill of Lading | Different Types of Bill of Lading | Airway Bill
Lecture 135Airfreight calculation | Gross Weight | Tare Weight | New Weight | Volumetric Calculation | Freight rate calculation
Section 10Inspection and Audit of Food Plant
Lecture 136Establishment Inspection Report | 483 Observations | USFDA Warning Letter | Handling of FDA inspection | Closing of Warning Letter
Lecture 137Data Integrity
Lecture 138Electronic Batch Record for effective compliance management | Key Understanding | Functionalities | Importance in managing data integrity
Lecture 139RTQs | Response to Queries | How to handle Regulatory Queries
Section 11Introduction to AI in Regulatory Affairs
Lecture 140Introduction to AI
Lecture 141Basics of AI ML DL | Key Differences | Application in industry
Lecture 142Types of AI
Lecture 143AI Project | Overview
Lecture 144Comprehensive Training on AI Project | Managing Stages | AI Iteration
Lecture 145How machine learning
Lecture 146Understanding Regulatory Affairs – Traditional vs. Digital | 2 Case Study
Lecture 147Basics of AI for Regulatory Professionals | Understanding different models used in RA | Case Study | Simulation
Lecture 148AI Application across drug life cycle | Case Analysis | Model predictions
Lecture 149AI Terms with Regulatory Significance | Regulatory Applications
Lecture 150NLP in Regulatory Affairs | Conceptual understanding | Usage | NLP in Labeling
Lecture 151Data Grouping with Unsupervised Learning | Case Simulation | Hands on Exercise
Lecture 152Quality Data and Bias | Bias in datasets | Different Types of Bias in Pharma Datasets
Lecture 153AI Data Quality Standard | Checklist
Lecture 154Download AI Data Quality Checklist
Lecture 155Case Study: Accelerated Approval Using Real-World Evidence AI
Lecture 156AI Model for Dossier Submission and Filing - Model Selection | Simulation
Lecture 157AI Technologies in RA
Lecture 158Structured Vs. Unstructured Data | Practical Understanding | Explore Patient Datasets
Lecture 159Sample Data Exercise | Data error | Data Refinement and Cleaning of the data
Section 12AI in Regulatory Authoring and CMC Writing
Lecture 160AI-Powered Regulatory Document Authoring and CMC Writing
Lecture 161AI Tools Comparison - Authoring and CMC Writing (Module 2 & 3)
Lecture 162Tips for Selecting AI Tools (CMC Authoring)
Lecture 163CMC - AI Workflow Checklist | Simulation Based Cases
Lecture 164HITL Regulatory Document Authoring
Lecture 165Confidence Score in Regulatory Authoring | Case Simulation in CMC Authoring
Lecture 166Confidence Scores in Data Extract in Regulatory Writing [Case Simulation]
Section 13eCTD v4.0 Training
Lecture 167eCTDV4.0 Fundamental Understanding | Structures | Key Features
Lecture 168eCTDV4.0 Structure | Lifecycle Management
Lecture 169eCTD Validation | Managing Validation | Tool Types | Types of Error | Validation Error Management
Lecture 170eCTD Validation Tools
Lecture 171eCTD Publishing Cycle
Lecture 172HL7 - Structure and Understanding in the context of eCTD V4.0
Lecture 173Tips and Submission Readiness Checklist
Lecture 174eCTD Submission Checklist Format
Section 14AI and Data Integrity | Regulatory Documentation | Case Based Learning | Understanding Data Integrity Principles | Application and Use Cases
Lecture 175AI and Data Integrity | Regulatory Documentation | Case Based Learning | Understanding Data Integrity Principles | Application and Use Cases
Lecture 176Cases of data breaches with explanation
Lecture 177Case Based Discussion : Data Breach in AI-Assisted CMC Drafting
Section 15AI in Regulatory Labelling and Artwork
Lecture 178CCDS Management
Lecture 179CCDS Management Tools - Native, AI Plus | Key Functionalities
Lecture 180AI Augmented Labelling Compliance System
Lecture 181Label Drift in CCDS Management | Simulation Case Study | AI Based Workflow in Label Drift detection and management
Lecture 182AI Review of Labels, PI and SMPC with help of the Case Based Simulation | 4 Case Simulations
Lecture 183CCDS Management Case Study | Pregnancy Warning Upgrade Case Study
Lecture 184CCDS Management Case Study | Case Based Analysis
Lecture 185Centralized Artwork Operation | Mechanism | Operation Step Planning
Lecture 186Case Study on Centralized Artwork Operation [Recall Management]
Lecture 187Artwork Management Terms | Key Understanding on Terminologies | Usage in Artwork Cases
Section 16AI Tools, Ethics and Future Landscape
Lecture 188AI Reg Tools - Review | Understanding Capabilities
Lecture 189Regulatory Authority View on AI Adoption
Lecture 190Data Sensitivity | Levels | Consequences | Management
Lecture 191Governance Flowchart – AI Tools in GxP Environments
Section 17AI Tools
Lecture 192RA Example - Generalist Vs. Specialist AI Tools
Lecture 193AI Generalist Overview (Life Science Focus)
Lecture 194Horizontal vs Vertical AI Tools
Lecture 195AI Tool Assessment Test
Lecture 196Citation Verification Workflow | AI Tools Management | Hallucination and HITL Action Plan
Section 18Prompt Engineering for Regulatory Authoring
Lecture 197Prompt Engineering – Basic Foundations of Prompt Writing | Different Prompt Framework | Case Based Examples
Lecture 198Special Prompting Structure - Case Based Prompt Designing
Lecture 199Special Prompting Structure - Case Based Prompt Designing
Lecture 200Workflow for writing AI Prompts with Life Science Industry Use Cases
Lecture 201PE Parameters | Controlling Creativity, Accuracy, and Output Behavior for Life-Science Applications | Simulation based decision making
Lecture 202How to adjust the parameters | Techniques
Lecture 203Creating A Detailed Regulatory Prompt | Designing Structured Prompt in Code Editor
