InstructorRoyed Training
TypeOnline Course
Price$490 USD / 27500 INR.
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Cosmetic Regulatory Affairs course

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.

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: PG Certification in Cosmetic Regulatory Affairs (PGCRA)
  • 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 can be completed within 1 month anytime.
  • 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

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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 1Fundamental Understanding on Cosmetics
Lecture 1Definition and Classification of the Cosmetics | Various Types of Classification | Classification based on ingredients, intended use | Regulatory Requirements
Lecture 2Cosmetic R&D Cycle | Development to commercialization process | NPD process | Understanding Key Responsibility Areas | Product Prototype Development | Compliance and Regulatory requirements for market launch
Lecture 3Cosmetic Categories and Type
Lecture 4Commonly available cosmetic formulation in market
Lecture 5Premarket Steps to consider before launching cosmetic brand in market
Lecture 6Detailed Understanding on Cosmetic Related Terminologies
Lecture 7Eye makeup cosmetic | Mascara | Eyeliner | Eye color | Eye makeup remover | Eyeshadow
Lecture 8Facial makeup cosmetic | Lip colors | Foundation | Concealers | Face Powder | Primers | Lipsticks and various classes | Lip gloss | Cheek colors
Lecture 9Bath 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 10Perfumes | Types | Ingredients | Manufacturing Process 
Lecture 11Baby Care Cosmetic | Baby Shampoo | Baby creams | Others
Lecture 12Nail range of cosmetics
Lecture 13Hair Products | Types of hairs | Hair tonic, dressing | Hair rinse | Hair shampoo | Conditioners | Hair color products | Hair Straighteners and Relaxers | Hair Sprays 
Lecture 14Personal cleanliness | Soap | Feminine Deodorants | Douches | Antiperspirants and Deodorants
Lecture 15Skin Care Range of Cosmetics
Lecture 16Shaving products
Lecture 17Sunscreens | SPF | Mechanism - Detailed understanding | Regulations | Labeling 
Lecture 18Oral Care Cosmetics
Lecture 19Regulatory classifications and definitions of cosmetic products
Lecture 20 Distinctions between cosmetics, drugs, and medical devices
Lecture 21Case Discussion : Cosmetic with therapeutic claims
Lecture 22Cosmetic Class and Segmentation | Usage | Mechanism | Examples
Section 2Cosmetic - Concepts to Product Development
Lecture 23Introduction to Goods and Products | Classification
Lecture 24FMCG - Overview of Consumer Goods| Types | Characteristics 
Lecture 25FMCG - Consumer | Types | Characteristics 
Lecture 26FMCG - Fast Moving Consumer Goods | Concept | Definition |Characteristic | FMCG Business Planning - Core Operational Area 
Lecture 27Difference between FMCG and OTC products
Lecture 28Pharmaceutical Market Vs FMCG Market
Lecture 29CMG | FMCG Vs. SMCG - Understanding of Small Moving Consumer Goods | Importance of SMCG
Lecture 30Retail Store Classification | Product-Patronage Matrix | MRAB | MRAS | MPB | MPS
Lecture 31ISIC Classification of FMCG Goods
Lecture 32FMCG Market Dynamics and Business Operation Overview
Lecture 33Cosmetic Product Development
Lecture 34Safety assessment and product testing of cosmetic
Section 3Cosmetics as Pharmaceuticals - R&D Process to Commericalization
Lecture 35R&D Cycle - New Drug Approval Process
Lecture 36Investigational New Drug Application
Lecture 37New Drug Application
Lecture 38Generic Drug Approval Process
Lecture 39Abbreviated New Drug Application (ANDA) Filing 
Section 4Clinical Study of Cosmetic Formulations
Lecture 40Explore : Clinical Study - Required?
Lecture 41Understanding on Clinical Trials  and Clinical Research 
Lecture 42Clinical Trial Protocol Writing
Lecture 43Ethics in Clinical Research
Lecture 44Informed Consent | Practical Training on preparing ICF | Ready Templates
Section 5International harmonization efforts in cosmetic regulations
Section 6GMP Requirements for Cosmetic Manufacturing Units
Lecture 46Premises & Plant Layout Designing
Lecture 47Sanitation and Hygiene
Lecture 48Equipment Modules
Lecture 49Production Modules
Lecture 50Documentation
Lecture 51Quality Control
Lecture 52Product Complaint
Lecture 53Storage Module
Lecture 54Quality Risk Management | ICH Q9 | ISO 14971 | Principle of Risk Management 
Lecture 55Data Integrity issues in Pharmaceutical Industry : Detailed Understanding 
Lecture 56Establishment Inspection Report | 483 Observations | USFDA Warning Letter | Handling of FDA inspection | Closing of Warning Letter 
Lecture 57Electronic Batch Record for effective compliance management | Key Understanding | Functionalities | Importance in managing data integrity
Lecture 58RTQs | Response to Queries | How to handle Regulatory Queries  
Section 7Cometic Labeling Requirements and Guidelines
Lecture 59Cometic Labeling Requirements and Guidelines
Lecture 60Claims substantiation for cosmetic products labeling 
Lecture 61Multilingual labeling for cosmetic formulations
Lecture 62Ingredient declarations in cosmetic labeling
Lecture 63The role and structure of the Product Information File (PIF) for cosmetic products
Lecture 64PIF preparation and maintenance
Section 8Cosmetic Product Dossier (CPD)
Lecture 65Fundamental of Cosmetic Product Dossier (CPD)
Lecture 66Key Note Points Regarding CPD