The course will provide information on what is involved in getting an International Nomenclature Chemical name assignment (INCI), why there is a need to proper back-labeling, and how to utilize the INCI dictionary as a valuable resource tool.
INCI is a harmonized global process, and this course will delve into the relationship between US and other global area for labeling and ingredient nomenclature. After completion of this 90-minute presentation, you should be able to understand how to use the INCI dictionary and handbook, understand the requirement and interpretation of USA FDA Fair Package and Labeling Act, and how other countries approach labeling.
Areas Covered in the Seminar:
- Who is INC.
- How to submit a Tradename application for INC monograph assignment.
- Rules to Personal Care Cosmetic back labeling.
- The symbiotic relationship between DMFs and current Good Manufacturing Practices (cGMPs).
- Common DMF errors - how to avoid them.
- How to deal with deficiency letters and their origins.
- Effective change control strategies.
- Ramifications of inadequate preparation and/or maintenance and recent enforcement actions and inspectional trends.
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Enhancing global compliance, creating a world where quality and compliance professionals, regulators, and government agencies come together to help the world comply with the intent and the spirit of laws, policies and mandates.