Regulatory Affairs, Assessments, and Quality Management

  • Level of Education

    5 years of post-secondary education

  • ECTS

    4 credits

  • Training Structure

    College of Sciences

Description

Overview of European legislation and its hierarchy: regulations, directives, decisions, resolutions, national laws, and the institutions and authorities responsible for the regulatory system.

Overview of Key Regulations Around the World and a General View of Progress

 

Institutions and Authorities Responsible for the Regulatory System

Regulatory Framework for Cosmetic Packaging

The Process of Ensuring Compliance for Cosmetic Packaging and Its Main Challenges

New Requirements for Cosmetic Packaging Under European and French Laws on the Circular Economy

 

The course will cover Good Manufacturing Practices (GMP) designed to ensure the reproducibility and quality of cosmetic manufacturing.

It will help identify the measures to be taken regarding production, quality control, storage, and shipping processes, and ensure that cosmetic products comply with applicable regulations (Regulation (EC) No. 1223/2009, ISO 22716, etc.).

Hourly volumes*:

            CM: 15

            TD: 15

            Lot: 10

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Objectives

Knowledge of key regulations:

  • Authorities
  • Main Texts
  • Raw Material Regulations
  • Product Classification (and Overview of Border Regulations)
  • Comparison with European regulations.

Knowledge of certifications and standards in organic and natural cosmetics.

Understand and know how to apply international regulations (raw materials, products, packaging) and specific standards.

Understand and know how to comply with certifications and standards in organic and natural cosmetics

Understand, know how to apply, and know how to organize GMPs for all stages of a cosmetic product’s life cycle.

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Class Hours

  • Regulatory Affairs, Assessments, and Quality Management - CMLecture3:00 p.m.
  • Regulatory Affairs, Assessments, and Quality Management - TutorialTutorials3:00 p.m.

Mandatory Prerequisites

Knowledge of European Regulation (EC) No. 1223/2009

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Knowledge Assessment

Continuous Integral Control

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Course Outline

Courses taught by industry professionals and faculty members specializing in the relevant field. This module may be supplemented by lectures.

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Additional Information

Administrative contact(s):

Master's in Chemistry Office

https://master-chimie.edu.umontpellier.fr/

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