Regulatory affairs, assessments, and quality management

  • Level of education

    Master's degree

  • ECTS

    4 credits

  • Training structure

    Faculty of Science

Description

Reminder of European legislation and its hierarchy: regulations, directives, decisions, resolutions, national laws, institutions, and authorities in charge of the regulatory system.

Description of key regulations around the world and overview of progress

 

Institutions and authorities responsible for the regulatory system

Regulatory framework applicable to cosmetic packaging

The process of ensuring cosmetic packaging compliance and its main challenges

New requirements applicable to cosmetic packaging under European and French circular economy laws

 

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

It will enable you to identify the measures to be taken with regard to production, control, storage, and shipping processes and to ensure the compliance of cosmetic products with current regulations (EC 1223/2009, ISO 22716 standard, etc.).

Hourly volumes:

            CM: 15

            TD: 15

            Land: 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.

Know and be able to apply international regulations (raw materials, products, packaging) and specific standards.

Understanding and responding to certifications and standards in organic and natural cosmetics

Knowing, applying, and organizing GMPs for all stages of a cosmetic product's life cycle.

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Teaching hours

  • Regulatory Affairs, Assessments, and Quality Management - CMLecture3 p.m.
  • Regulatory affairs, assessments, and quality management - TutorialTutorials3 p.m.

Mandatory prerequisites

Knowledge of European Regulation EC 1223/2009

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Knowledge assessment

Continuous assessment

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Syllabus

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

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Additional information

Administrative contact(s):

Master's Program in Chemistry Secretariat

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

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