Cosmetics - How Are they Regulated?

Why Should You Attend:

Being unaware of the regulations that apply to the cosmetics industry is a tenuous position to be in. Should your products come under scrutiny, will you be able to pass FDA and state inspections or will your business be in jeopardy?

This presentation will help the management and staff of cosmetics companies to understand the regulations and how they apply to their products. It will help attendees gain a strong understanding of what is involved in becoming compliant in manufacturing, labeling and advertising of cosmetic products. Attendees will learn the importance of documenting and following up on consumer complaints, the marketing errors to avoid, the value of tracking lots, maintaining retention samples, having a quarantine area and its purpose, the necessity in using good manufacturing practices (GMP) in the manufacturing of cosmetics and the possibility of needing a quality testing program.

Whether you are a contract manufacturer or make your own products, compliance with GMPs will ensure quality production, and minimize corporate risk. Safeguarding consumer health is a key priority. Compliance will also ensure successful FDA and state inspections. This session will include the key principles of GMP as defined by FDA as well as incorporate FDA regulatory inspection strategy to identify areas of common deficiency.

Areas Covered in the Webinar:

• Differences between drugs and cosmetics.
• Good Manufacturing Practice (GMP).
• Role of quality Assurance in the manufacturing process.
• Responsibilities of management in FDA compliance.
• Importance of a good product surveillance program.
• Education of employees on GMPs and complaint handling.
• Activities that are common to manufacturing processes.
• Linking responsibility to these activities.
• State Health Departments and their relationship with FDA.
• Case study on the manufacture of a cosmetic from raw materials to sale.

Who Will Benefit:

This webinar will provide valuable assistance to the following personnel:

• Business owners
• Managers in manufacturing and customer service
• New staff in manufacturing
• Quality Assurance
• Administrative managers in charge of operations
• Regulatory Compliance Associates and Managers

Instructor Profile:

Susan Augello-Vaisey,M.S. is the owner and Senior Consultant at Pharma Consulting Solutions, LLC. She is a consultant in the cosmetic and pharmaceutical industry and is the author and presenter of multiple GMP and GCP compliance related courses and programs. She has successfully led small cosmetic firms through the metamorphosis from total non-compliance with imminent shut-down through system development and company education to regulatory compliance. These changes resulted in improved company compliance and increased market value.

Topic Background:

The Food and Drug Administration (FDA) is responsible for regulating not only foods and drugs, but also cosmetics under the Federal Food, Drug, and Cosmetics Act (FD&C Act). The laws governing drugs and cosmetics differ and knowing the difference can be critical to your cosmetics business. Registration of your business with FDA is voluntary, but compliance with the regulations is not. It is extremely common for cosmetics companies to be unaware of the manufacturing, labeling and promotion requirements and find themselves in violation without a clear understanding of what is required. Documentation failures and lapses in good manufacturing practices amongst other issues can impact regulatory compliance and ultimately consumer health.

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