OTC Drug and Personal Care Product GMP & FDA Regulation
Course Director
Course Fee
$2650.00 Regular Registration
$2450.00 Early Bird Pricing (Register 30 Days in Advance)
Course Brochure
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Future Live Stream Sessions (click to register)
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). This course focuses on two main categories: OTC drug and personal care products.
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.
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 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 20-hour course focuses on the regulatory control and GMP compliance requirements for various over-the-counter drugs and personal care products in the US, while also referencing key relevant 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
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.