Producers of handcrafted cosmetics products have become more popular over the past ten years. Cosmetics offer higher margins, less risky production, and less FDA regulatory scrutiny than food manufacturing. Or do they? The Modernization of Cosmetics Manufacturing Act (MoCRA) is the most significant expansion of the FDA’s authority to regulate cosmetics since the Food, Drug, and Cosmetics Act of 1938. This new regulation gives the FDA expanded authority, including access to records and mandatory recall authority. This new regulation includes adverse event reporting, facility registration, product listing, and safety substantiation. This overview will discuss some of the most critical topics, including good manufacturing practices, label claims, quality management, and the new regulations posed for cosmetics producers.
Cosmetics quality assurance professionals, regulatory affairs personnel, auditors, and anyone involved in implementing or managing food, beverage, and natural product manufacturing facilities.
- Cosmetics manufacturing
- Lab testing
- Quality
- Product Safety
- GMPs
- Recognize the requirements for Modernization of Cosmetics Manufacturing Act (MoCRA)
- Explain how the regulation affects them
- Identify good manufacturing practices, safety and quality management systems, lab testing
- Understand the draft guidance for cosmetics manufacturers
Group exercises include:
- Let’s play GMP Candyland.
- Colored squares are associated with each P.
- Pull a card to find what square you will move to and answer the question on the card, if correct stay on the square, if wrong move back to previous space.
- Special squares trigger special events.
- Roll a die to determine the number of points you get
- Hold a card on your head.
- Have your partner describe the card which has a picture of someone violating a GMP (they cannot state the regulation).
- Guess which GMP standard is being violated You get points for a correct answer, negative points for a wrong answer.
- Most points wins.
- YEAH or Nah lab practices.
- Read aloud best practices.
- If you are already doing them, it’s a YEAH.
- You get one point and get to pick a card for the chance to win potential bonus points (some of the cards give points, and some take away points.
- If you’re not already doing them, it’s a NAH.
- You don’t get a point unless you choose a card from the NAH deck, which requires you to do something to earn your point
Delivered online with a live instructor at a scheduled date and time.
Intermediate
