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