InstructorRoyed Training
TypeOnline Course
Student Enrolled1
(1 ratings)
Price$530/ 47700 INR.
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Cosmetic Regulatory Affairs Course by Royed Training

Introduction

Features

Related Courses

About Cosmetic RA

Cometic Regulatory Affairs Courses

The Cosmetic Regulatory Affairs Training course is designed to provide a comprehensive understanding of the regulations and requirements governing the discovery, development and regulatory aspects of cosmetic products. Participants will gain the knowledge and skills needed to navigate the intricate landscape of cosmetic regulations, ensuring compliance with national and international standards. This course is an essential resource for professionals in the cosmetics industry, including regulatory affairs specialists, product developers, quality control experts, and even marketers.

Moreover, this online cosmetic regulatory affairs course provides hands on exposure on practical aspects of cosmetic regulation documentation registration process.

Major focus is on learning how cosmetic R&D, process development, manufacturing takes place. Further, it covers regulation and registration strategic management processes. Hence, this is a comprehensive training program that provides detailed understanding of the cosmetic dossier preparation process and CMC writing. Overall, the participants will get the real life understanding in the steps of the cosmetic R&D, process development, and commercialization process. Hence this course provides real life training on cosmetic regulatory strategic management processes.

From R&D to Global Market Access, this hands-on course is your complete guide to regulatory excellence in the cosmetics industry!

Online Interactive Training on Cosmetic Regulatory Affairs

This online cosmetic regulatory affairs training course is self paced. Therefore the course can be accessed 24×7 across anywhere.

The unique interactive learning tools are used in this course to guide each participant through the process of cosmetic regulation and registration process. In addition, the course challenges students and professionals to apply what they have learned through the use of interactive exercises, marketing simulation, reflection questions, expert live chat and a final assessment at the end of the course. Most importantly these advanced tools are very effective for providing insight on how to prepare submission dossier for cosmetic products. 

Snapshot of the Cosmetic Regulatory Affairs course

The course is self paced learning. Therefore, the course can be accessed 24×7, allowing the user to stop and start at their leisure. Hence, it is quite convenient to learn on the go.

  • Course Code: RYD-112
  • Course Title: Advanced Certification in Cosmetic Regulatory Affairs (ACCRA)
  • Nature of the course: Online distance learning course. Therefore the course can be accessed online across anywhere 24×7.
  • Duration: Maximum duration of the course is 1 Month.
  • Course Certificate: Certificate will be provided at the end of the successful completion of the course.
  • Eligibility: Graduation in any discipline. Even final year graduation students can apply.

Features of the Cosmetic Regulatory Affairs Course

This Cosmetic Regulatory Affairs online course utilizes interactive e-learning tools. Hence, this provides seamless practical learning experience.

This online cosmetic training course will focus on understanding regulatory affairs and strategic management skills which are required for effective functioning as regulatory personnel who are planning to join already working in cosmetic manufacturing and marketing companies. Indeed, advanced simulation in the course will challenge students to apply what they have learned from the course. In addition, there are advanced learning tools like interactive exercises, reflection questions, and expert live chat which makes the course very interesting.

Key features of the course

  • 24×7 Online Access. Therefore, access the course anytime from anywhere across the globe.
  • Students can download the course materials from the dashboard. Hence, it helps them to study offline even after completion of the course.
  • Access the e-lectures, case studies, self assessment modules and practical sessions through personalized web pages.
  • Moreover, the final examination is online. Hence students can attend the final examination at their own convenient date and time.

Some related courses

About Cosmetic Regulatory Affairs

Cosmetic regulatory affairs refer to the set of laws, regulations, and processes that govern the manufacturing, labeling, marketing, and sale of cosmetic products.  Here are some key areas of training regarding cosmetic regulatory affairs:

Product Safety

Regulatory agencies, such as the FDA (Food and Drug Administration) in the United States and the European Commission in Europe, set safety standards for cosmetic ingredients. Manufacturers must ensure that their products do not contain harmful or banned substances and that they undergo safety testing.

Ingredient Labeling

Cosmetic products must accurately list all ingredients on their labels. This helps consumers make informed choices and is crucial for individuals with allergies or sensitivities.

Claims and Advertising

Companies must be truthful in their marketing and advertising. They cannot make false claims about the benefits or effectiveness of their products. Regulatory agencies monitor and regulate these claims.

Good Manufacturing Practices (GMPs)

Manufacturers must adhere to GMPs to ensure the quality and consistency of their products. This includes maintaining proper hygiene, quality control, and record-keeping.

Registration and Notification

In some countries, manufacturer must register the cosmetic formulations to the regulatory authority before they starts marketing. This allows the regulatory agency to track products and ingredients on the market.

Packaging and Labeling

Labeling is one of the key component of cosmetic branding and marketing. In fact cosmetic formulation packaging and labeling must be as per regulatory guideline. This includes requirements for language, font size, and placement of essential information on the product label.

Cosmetic Ingredients

Certain ingredients, such as color additives, sunscreens, and active pharmaceutical ingredients, may have specific regulations and require approval before use in cosmetics.

Cosmetic Claims and Classification

Products may be classified as cosmetics, drugs, or both, depending on their intended use and claims. Hence, this classification can affect the regulatory requirements they must meet.

International Harmonization

In some cases, there are efforts to harmonize cosmetic regulations internationally to facilitate the global trade of cosmetic products. For example, the International Cooperation on Cosmetics Regulation (ICCR) brings together regulatory authorities from different countries to work on harmonizing regulations.

Post-Market Surveillance

Above all, Regulatory agencies monitor the safety of cosmetic products on the market. And agencies may take action if safety concerns arise. This can include recalls, warnings, or further testing.

It’s important for companies in the cosmetic industry to stay informed about the specific regulations in the regions where they sell their products and to ensure compliance with these regulations. Failure to do so can result in legal consequences and damage to a company’s reputation. Therefore, cosmetic regulatory affairs play a vital role in the cosmetics industry to ensure the safety and integrity of products.

Section 1Global Cosmetic Regulation - Fundamental to advance understanding
Lecture 1Cosmetic Global Legal Perspective | Concepts | Understanding definition | Classification System | Boderline Evaluation
Lecture 2Cosmetic Boderline Determination Classification | Misclassification | Reclassification
Lecture 3Cosmetic Risk Philosophy | Risk Structuring | Product Safety Responsibility Model | Practical Case Analysis 
Lecture 4Simulation - Risk Based Regulatory System for Cosmetics
Lecture 5Risk-based safety classification table for cosmetic product types (RA working model)
Lecture 6Risk-Based Cosmetic Safety Classification & RA Intake Template
Lecture 7Concept of Claim Reframing
Lecture 8Claim Reframing Matrix
Lecture 9Case Study : Reclassification of a Skin Brightening Serum
Lecture 10Strategic Management of Cosmetic Claim in Question
Lecture 11How Marketing Claims Trigger Reclassification
Section 2EU Cosmetic Regulation
Lecture 12EU Cosmetic Regulation | Framework | CPNP | PIF | CPSP
Lecture 13CPNP Pathway & Framework 
Lecture 14Structured Training on PIF Documentation
Lecture 15EU Product Information File (PIF) - Master Template Structure
Lecture 16EINECS Number | ELINCS Number | EC Number
Lecture 17CAS Number | Importance in Sourcing | Case study
Lecture 18NLP Number | Cosmetic Identifier Strategic Significance
Lecture 19REACH Compliance Verification
Lecture 20Cosmetic Product Safety Report (CPSR) : Writing Guidance Module
Lecture 21Sample CPSR | MOS Calculation
Lecture 22Fundamental Understanding on Annex II
Lecture 23Annex II Categorization
Lecture 24Detailed understanding on Annex III
Lecture 25Annex III Master List
Lecture 26Colorant in Cosmetic Formulation | Annex IV
Lecture 27CI Numbers – Detailed Regulatory Understanding
Lecture 28Annex IV Master CI
Lecture 29Preservative in Cosmetic Formulation | Annex V
Lecture 30Preservative Annex V Master List
Lecture 31Annex VI – UV Filters | Classification of UV Filters | Strategic Regulatory Considerations
Lecture 32UV Filters Master List | Annex VI Positive List
Lecture 33Simulation : Sunscreen Regulatory Evaluation Simulation
Lecture 34EU Cosmetic Regulation - Review Test 
Lecture 35EU Cosmetic Regulation - Case Studies
Section 3US Cosmetic Regulation
Lecture 36US Cosmetic Regulation | Introduction
Lecture 37Voluntary Cosmetic Registration Program (VCRP)
Lecture 38VCRP Filing Process and Checklist | Checklist for FDA VCRP Registration and Product Filing Process
Lecture 39Modernization of Cosmetics Regulation Act (MoCRA)
Lecture 40Transitioning from MoCRA to VCRP
Lecture 41MoCRA Exemptions | Exemption Calculation | Exemption templates | Scenario based case studies | Declaration | Open format Template
Lecture 42MoCRA Compliance Checklist
Lecture 43MoCRA Advanced Case Study | Regulatory Strategic Planning 
Lecture 44MoCRA Regulation Decision Tree | Action Plans
Lecture 45MoCRA Case Based Assignment
Lecture 46MoCRA Forms 
Lecture 47Global Cosmetic Regulation - Review Test 1 
Lecture 48US Cosmetic Regulation - At A Glance | Compliance Snapshots
Lecture 49Strategic Pathway for US Cosmetic Formulation Market Access
Lecture 50Cosmetic vs Drug Claim - Decision Tree
Lecture 51US Cosmetic vs OTC Drug Claim Risk Scoring Matrix
Lecture 52Cosmetic Claim Rewriting Guide
Section 4Fundamental Understanding on Cosmetics
Lecture 53Definition and Classification of the Cosmetics | Various Types of Classification | Classification based on ingredients, intended use | Regulatory Requirements
Lecture 54Cosmetic R&D Cycle | Development to commercialization process | NPD process | Understanding Key Responsibility Areas | Product Prototype Development | Compliance and Regulatory requirements for market launch
Lecture 55Cosmetic Categories and Type
Lecture 56Commonly available cosmetic formulation in market
Lecture 57Premarket Steps to consider before launching cosmetic brand in market
Lecture 58Eye makeup cosmetic | Mascara | Eyeliner | Eye color | Eye makeup remover | Eyeshadow
Lecture 59Facial makeup cosmetic | Lip colors | Foundation | Concealers | Face Powder | Primers | Lipsticks and various classes | Lip gloss | Cheek colors
Lecture 60Bath Products | bath capsules, bath oils, tablets and salts, and bubble baths | Body Wash | Body Soap | Shower Gel | Skin Type | Usage based positioning based on Skin Type
Lecture 61Perfumes | Types | Ingredients | Manufacturing Process 
Lecture 62Baby Care Cosmetic | Baby Shampoo | Baby creams | Others
Lecture 63Nail range of cosmetics
Lecture 64Hair Products | Types of hairs | Hair tonic, dressing | Hair rinse | Hair shampoo | Conditioners | Hair color products | Hair Straighteners and Relaxers | Hair Sprays 
Lecture 65Personal cleanliness | Soap | Feminine Deodorants | Douches | Antiperspirants and Deodorants
Lecture 66Skin Care Range of Cosmetics
Lecture 67Shaving products
Lecture 68Sunscreens | SPF | Mechanism - Detailed understanding | Regulations | Labeling 
Lecture 69Oral Care Cosmetics
Lecture 70Cosmetic Class and Segmentation | Usage | Mechanism | Examples
Section 5Cosmetic - Concepts to Product Development
Lecture 71Introduction to Goods and Products | Classification
Lecture 72FMCG - Overview of Consumer Goods| Types | Characteristics 
Lecture 73FMCG - Consumer | Types | Characteristics 
Lecture 74FMCG - Fast Moving Consumer Goods | Concept | Definition |Characteristic | FMCG Business Planning - Core Operational Area 
Lecture 75Difference between FMCG and OTC products
Lecture 76Pharmaceutical Market Vs FMCG Market
Lecture 77CMG | FMCG Vs. SMCG - Understanding of Small Moving Consumer Goods | Importance of SMCG
Lecture 78Retail Store Classification | Product-Patronage Matrix | MRAB | MRAS | MPB | MPS
Lecture 79ISIC Classification of FMCG Goods
Lecture 80FMCG Market Dynamics and Business Operation Overview
Lecture 81Cosmetic Product Development
Lecture 82Safety assessment and product testing of cosmetic
Section 6GMP Requirements for Cosmetic Manufacturing Units
Lecture 83Premises & Plant Layout Designing
Lecture 84Sanitation and Hygiene
Lecture 85Equipment Modules
Lecture 86Production Modules
Lecture 87Documentation
Lecture 88Quality Control
Lecture 89Product Complaint
Lecture 90Storage Module
Lecture 91Quality Risk Management | ICH Q9 | ISO 14971 | Principle of Risk Management 
Lecture 92Data Integrity issues in Pharmaceutical Industry : Detailed Understanding 
Lecture 93Establishment Inspection Report | 483 Observations | USFDA Warning Letter | Handling of FDA inspection | Closing of Warning Letter 
Lecture 94Electronic Batch Record for effective compliance management | Key Understanding | Functionalities | Importance in managing data integrity
Lecture 95RTQs | Response to Queries | How to handle Regulatory Queries  
Section 7Cometic Labeling Requirements and Guidelines
Lecture 96Cometic Labeling Requirements and Guidelines
Lecture 97Claims substantiation for cosmetic products labeling 
Lecture 98Multilingual labeling for cosmetic formulations
Lecture 99Ingredient declarations in cosmetic labeling
Lecture 100The role and structure of the Product Information File (PIF) for cosmetic products
Lecture 101PIF preparation and maintenance
Section 8Dermatology Cosmetic Formulations - Drug Class - Regulation, Registration and Strategic Planning
Lecture 102R&D Process & Introduction to drug discovery
Lecture 103Investigational New Drug Application (INDA)
Lecture 104New Drug Application (NDA) 
Lecture 105Basic concept and understanding of the Generic Drug
Lecture 106Abbreviated New Drug Application (ANDA) Filing 
Lecture 107Understanding on Clinical Trials  and Clinical Research 
Lecture 108Chemistry, Manufacturing & Controls 
Lecture 109Fundamental of CMC | Detailed understanding of CMC section writing | Important Points regarding CMC | Drug Product and Drug Substance | Excipient, FP, Analysis and Stability Study Requirements
Lecture 110Common Technical Document (CTD)
Lecture 111CMC Dossier & Compliance Management
Lecture 112Drug Master File Preparation and Submission 
Lecture 113Practical Understanding on Drug Master File Preparation and Submission
Lecture 114Certificate of Analysis
Lecture 115PKPD in Drug Discovery | PK-PD trial | Understanding PKPD from regulatory perspective in drug approval process
Lecture 116Bioequivalence Study | Study design | Different types of BE Studies
Lecture 117Bioequivalence Study | Study design | Parallel Study | Crossover study design | Other alternative study designs | Blood Sampling Planning  | Analyte | Bioanalytical Methods Validation  | Statistical Model  | Ln Transformation  | Dose normalisation | Confidence interval acceptance criteria
Lecture 118Variation Classification | Basis of Classification | US and EU Variation Classification | Other region variation guideline.
Section 9Regulation of OTC cosmeceuticals
Lecture 119OTC Switch 
Lecture 120OTC vs Prescription Labelling | Claim Limitations & Consumer Safety Requirements
Lecture 121OTC vs Prescription (Rx) Label Checklist
Lecture 122OTC Approval Matrix 
Lecture 123OTC Claim Risk Scoring System
Section 10Stability Study - Regulations and Guidelines
Lecture 124Modules on Stability Study : Stability Study - Fundamental Understanding | Interchangebility | Reports | API & FPP Stability Study
Lecture 125Climatic Zone and Stability Study Conditions as per ICH Guidelines 
Lecture 126Stability Zone Finder
Lecture 127Stability Studies Case Discussions
Lecture 128Case Study: Managing Stability Study for Zone IV countries
Lecture 129Accelerated and intermediate testing conditions
Lecture 130Long Term Stability Testing Requirements
Lecture 131Testing Frequency
Lecture 132Bracketing
Lecture 133Matrixing
Section 11Request for Course Certificate