Industries: Pharma / BiotechSkin & Cosmetics

GMPs for OTC & Cosmetic Products - US and Global Requirements

Course Director: Wen Schroeder

Course Fee: $2150.00 Regular Registration / $1950.00 Early Bird (30 Days in Advance)

Course Description -

Personal care products in the US often fall into two regulatory product categories regulated by the FDA: the cosmetic and the OTC products. Both are regulated under the Federal Food, Drug and Cosmetic Act (FFD&C Act). As is required under Section 501(a)(2)(B) of this act, drugs manufactured in the US must conform to current good manufacturing practices (cGMPs), prescription and OTC alike. GMPs outline regulatory requirements for the manufacturing, processing and packaging of pharmaceutical products to ensure their safety and effectiveness. The act further stipulates that cosmetics introduced into interstate commerce should not be adulterated or misbranded.

The cosmetic good manufacturing practice is a set of manufacturing guidelines to ensure the safety and quality of cosmetic products. Rigorous adherence to good manufacturing practice minimizes the risk of adulteration or misbranding of cosmetics. This course outlines the international development and harmonization of GMPs relevant to cosmetic and OTC products with detailed discussion in key areas of concern ranging from the facilities to personnel to material control to corrective/preventative measures and recordkeeping.

Who Should Attend

This OTC certification program focuses on the regulatory requirements of good manufacturing practices for OTC and cosmetic products in the US while also referencing key international counterpart to provide a well rounded world view for the participants. It is designed for professionals in the personal care, cosmetic, chemical application and pharmaceutical industries engaged in all aspects of personal care product development, including the raw material suppliers, in the following areas:

  • Research & Development
  • Technology, Formulation & Product Development
  • Marketing & Technical Sales
  • Regulatory Affairs
  • QA & QC Professionals
  • Business Decision Makers

Course Agenda

First Day

Introductions & Agenda Review

Session 1. Global Cosmetic & Toiletry Market

  • Market trends & consumer behavior
  • Current affairs

Session 2. Regulatory Review of the Control of Personal Care Products in the World

  • Definition & classification: drug vs. cosmetic
  • Global regulatory comparison & contrast
  • Other relevant legislation

Session 3. Introduction to Pharmaceutical cGMPs

  • Global quality system overview
    • Historical background
    • International legal basis
    • Global GMP trend watch
    • International harmonization
  • Pharmaceutical quality system framework in the US
    • Quality system overview
    • Legal basis
    • Guidance to the industry

Session 4. Cosmetic GMPs – A Trip around the World

  • Historical background
  • Global regulatory framework concerning cosmetic GMPs
  • International standards & harmonization
    • ISO 22716
    • USFDA
    • Others

Second Day

Session 5. Global Current Affairs

  • Existing & emerging issues
    • Quality, authenticity & counterfeit
    • Sourcing & supply
    • Tracking & inventory
    • Efficiency management
    • Relevant chemical control & management

Session 6. Workshop

  • GMP comparison & contrast: Cosmetics vs. Pharmaceuticals
  • Case studies
  • Recap, questions and answers

Session 7. The Dreaded FDA Inspection

  • Definition
    • Self-audit vs. regulatory inspection
  • Self audit essentials
  • Preparing for an FDA inspection
  • Post FDA inspection measures

Session 8. Workshop - The Dreaded FDA Inspection

  • Case studies
  • Group exercise: FDA field inspector vs. the manufacturer
  • Discussion, review, recap, questions & answers

Learning Objectives

Upon completion of this course, the participants will be able to:

  • Describe the legal basis & industrial standards regulating the manufacture of personal care products including OTC and cosmetic products
  • Compare and contrast regional specifics concerning GMPs requirements and industrial best practices for personal care product in a global market
  • Describe specific regulatory requirements pertaining to good quality management / manufacturing practices of personal care products
  • Outline steps and tools to establish and implement an effective GMP/quality management system
  • Design a self-audit program and/or preparation plan for an FDA inspection


"Compared to courses by other providers this was much better and more comprehensive. The supporting case studies kept the audience fully engaged. The course director was very experienced and delivered interesting real-life examples." Ruben C., Director of Quality, Universal Beauty Products
"The experience of the Course Director was critical to this great course! She added excellent insight. The case studies were very enjoyable." Carl R., Supplier Quality Compliance Manager, Clorox
"The Course Director took time to answer questions throughout the course. The discussion opportunity this provided was very beneficial." Tammy V., OTC QE, Dow Corning Corporation
"A well-organized, thorough, well-paced overview of VMP, cGMP and validation requirements presented in a manner that anyone could understand. Well done!" Kirk J., Corporate Engineering Manager, Alberto Culver
"The Course Director kept the course interesting. She was extremely knowledgeable and answered all questions to the point." Shiv R., Sr. Scientist, J&J
"The Course Director was knowledgeable and presented the material well." Eileen M., QA/QC Manager, Arkema, Inc.