The Leader in Quality Life Science Training

OTC Drug and Personal Care Product GMP & FDA Regulation

  • Slide title

    "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

  • Slide title

    "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

  • Slide title

    "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.

Course Director

Course Fee

$2150.00 Regular Registration

$1950.00 Early Bird Pricing (Register 30 Days in Advance)

Course Description

Personal care consumer products in the US encompass a broad spectrum of categories, ranging from food/supplements to cosmetics to OTC drug products. They are mainly regulated by the FDA 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 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. 


Both finished dietary supplement products and dietary ingredients are regulated by the FDA as stipulated by the Dietary Supplement Health and Education Act of 1994. Dietary supplements cGMP compliance, such as manufacturing, packaging, labeling and marketing, is required under 21 CFR part 111.



This course aims to provide the participants with a useful, step-by-step guide in setting up a comprehensive GMP program. It outlines the international development and harmonization of GMPs relevant to these over-the-counter consumer personal care 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 15 hour course focuses on the regulatory requirements of good manufacturing practices for various over-the-counter drugs and consumer/personal care products in the US while also referencing key international counterpart. It is designed for professionals in the personal care (e.g., drugs, cosmetic, and consumer products) industries engaged in all aspects of product development including

 

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

  • Agenda


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

    Session 4. Cosmetic GMPs – A Trip around the World

    • Historical background
    • Global regulatory framework concerning cosmetic GMPs
    • International standards & harmonization
    1. ISO 22716
    2. COLIPA & ASEAN
    3. USFDA
    4. Others

    Session 5. Global Current Affairs

    • Existing & emerging issues
    1. Quality, authenticity & counterfeit
    2. Sourcing & supply
    3. Tracking & inventory
    4. Efficiency management
    5. 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
    1. 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

  • Testimonials

    "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.

Registrant Information:

Each person attending a course will be asked to set up an Attendee Profile Account during the registration process. Creating an Account helps you view your order history and manage your training programs. If you are registering for others, please set up an Account in the Attendee’s name. If you are registering more than one person, you’ll need to set up a separate account for each Attendee.

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