OTC Drug and Personal Care Product GMP & FDA Regulation

  • A white background with a few lines on it

    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

  • A white background with a few lines on it

    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

  • A white background with a few lines on it

    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 white background with a few lines on it

    "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

  • A white background with a few lines on it

    "The Course Director kept the course interesting. She was extremely knowledgeable and answered all questions to the point."


    Shiv R., Sr. Scientist, J&J

  • A white background with a few lines on it

    "The Course Director was knowledgeable and presented the material well."


    Eileen M., QA/QC Manager, Arkema, Inc.

A man in a suit and tie with a plus sign on his chest.

Course Director

A dollar sign in a circle on a white background.

Course Fee

$2650.00 Regular Registration

$2450.00 Early Bird Pricing (Register 30 Days in Advance)

A black and white icon of a calendar on a white background.

Course Description

Personal care consumer products in the U.S. encompass a broad spectrum of categories, ranging from food and supplements to cosmetics to over-the-counter (OTC) drug products. They are mainly regulated by the FDA under the Federal Food, Drug and Cosmetic Act (FFD&C Act). This OTC and cosmetic product good manufacturing practices (GMP) course focuses on drug and personal care products.


As is required under Section 501(a)(2)(B) of this act, drugs manufactured in the U.S. 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. 


Many OTC personal care products fall within the cosmetic product category. 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 global GMP standards for OTC and cosmetic products course also reviews how U.S. requirements compare with international regulatory frameworks for consistent compliance across jurisdictions and supply chains.


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/preventive measures and recordkeeping. During this OTC drug manufacturing GMP training, course director Wen Schroeder will touch on inspection audit preparation and documentation practices essential to the Federal Food, Drug and Cosmetic Act.

Who Should Attend

This 20-hour course focuses on the regulatory control and GMP compliance requirements for various over-the-counter drugs and personal care products in the U.S., while also referencing key relevant international counterparts. As a personal care product GMP requirements training, it is intended for professionals responsible for maintaining quality systems, manufacturing controls and regulatory compliance across product life cycles.


It is professionals in the personal care (e.g., drugs, cosmetics and consumer products) industries engaged in all aspects of product development, including:

  • Research and Development
  • Technology, Formulation and Product Development
  • Marketing and Technical Sales
  • Regulatory Affairs
  • QA and QC professionals
  • Business decision-makers
Register for Live Stream Request On-Site Details

  • Learning Objectives

    Upon completion of this cosmetic product regulations and compliance course, the participants will be able to:


    • Describe the legal basis, regulatory control and industrial standards regulating the manufacture of various over-the-counter drug and personal care products.
    • Compare and contrast GMP requirements and industrial best practices for these products marketed in the U.S.
    • Outline steps and tools to establish and implement an effective GMP/quality management system for these OTC products.
    • Design a self-audit program and/or preparation plan for an FDA inspection.
    • Define and classify a drug, cosmetic or combination product
    • Explain FDA labeling, post-market surveillance, compliant handling, recall and import compliance requirements

  • Agenda


    Introductions & Agenda Review


    Session 1. Introduction to Over-the-Counter Personal Care Consumer Products

    • Terminology
    • Product Types and Regulatory Categories
    • Market trends and consumer behavior  
    • Current affairs 

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

    • Definition and classification:  drug or cosmetic or something else?
    • Regulatory comparison and contrast
    1. Drugs 
    2. Cosmetics
    3. Topical antimicrobials (FDA vs. EPA Perspectives)
    • Relevant chemical control regulations

    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. U.S. OTC Drug Regulation Highlights

    • Historical and Current legislative development
    • Legal definition and distinction
    • Product classification standards
    • Path to regulatory “registration”
    1. OTC monograph
    2. NDA path
    3. What if you are a combination product?
    • Manufacturing requirements
    1. Control of PI
    2. Safety and effectiveness control
    3. Mandatory pharmaceutical cGMP compliance
    4. FDA inspections
    • Labeling/Advertising/Promotion rules
    • Post market surveillance
    1. Complaints and recalls
    2. Roles and responsibilities
    3. Follow-up and reporting responsibilities
    • Import requirements

    Session 5. Select FDA GMP Highlights

    • Cosmetic & Personal Care Products GMP
    • Other Relevant Chemical Control Regulations – A Global Review
    1. TSCA
    2. REACH
    • Summary, Discussion and Case Studies

    Session 6. The Dreaded FDA Inspection

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

    Session 7. FDA GMP Enforcement 

    • Enforcement Statistics, Highlights & Focus
    • Case studies
    • Discussion, review, recap, questions & answers

    Session 8. Global Current Affairs & Case Studies

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

  • 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.