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Manufacturing and Marketing Cosmeceutical* and Homeopathic OTCs: Complying with FDA's Rules for Drug Products that do not require FDA Pre-Approval

10 - 11 March 2015, San Diego, United States


Introduction
One and a half day In-person Seminar

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

Note: Use coupon code 232082 and get 10% off on registration
Speakers
  • Bill Schwemer Consultant in Biotechnology, Regulatory Compliance and Aseptic Processing Arena
    Bill Schwemer is an ex-FDA official having more than 50 years’ experience with FDA compliance matters. He has worked as an FDA field Investigator and Compliance Officer, been a senior official with FDA's Office of the Commissioner and was V-P of RA/QA at a Personal Care Products Company. Mr. Schwemer worked in all program areas, but has consulted primarily with pharmaceutical and personal care products companies.

    He has published more than 125 articles and since becoming a consultant has successfully served as a regulatory compliance expert witness in 20 lawsuits., United States

Venue
San Diego, CA

San Diego, CA, San Diego, CA, San Diego, 92093, United States

Committee
Organised by
ComplianceOnline
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