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  • Manufacturing and Marketing Cosmeceutical* and Homeopathic

  • Hosted By:
  • ComplianceOnline
  • Start:
  • Thursday - Nov 14, 2013 08:30 AM
  • End Time:
  • Friday - Nov 15, 2013 01:00 PM
  • Location:
  • South Beach,
    Florida, United States
  • Course Description:
    This interactive one and a half day seminar is intended to help companies understand the legal definitions of cosmetics, drugs, dietary supplements and why products of similar composition may be defined differently by their labeling and thus have to meet different regulatory requirements. It will also explain differences in the way homeopathic and conventional drugs are regulated.

    It will address such issues as:

    -How the intended use of the product owner defines a product
    -Can a drug contain both allopathic and homeopathic ingredients
    -Information that must appear on the principal display panel
    Type size requirements for label text
    -Understanding OTC Drug Monographs
    Elements of "drug facts" boxed labeling
    -How to label a product that has both OTC drug and cosmetic claims
    Basic requirements for marketing Homeopathic OTC drugs
    GMP requirements for cosmeceuticals that can be met at lower cost

    Learning Objectives:
    -Understand FDA rules and policies regarding manufacturing and labeling of low risk OTC drugs not covered by approved New Drug Applications.
    -Learn the definitions of drug, cosmetic, dietary supplement.
    -Understand how labeling other than labels and advertising can define a product and cause it to be misbranded or considered a new drug.
    -Differentiate cosmetic “puffery" claims from claims that FDA would likely consider drug claims.
    -Understand the differences between allopathic (conventional) drugs and homeopathic drugs.
    -Recognize ways to manufacture low health risk products at minimum cost, yet still meet the intent and basic requirements of GMP regulations.
    -Learn how to minimize the regulatory risk of a Warning Letter or other FDA action.
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