December 13 – 15, 2023
Part 1: If you’re entering the nutritional supplement market as a start-up, this training on facility design for Good Manufacturing Practice (GMP) compliance will teach you how to create a facility that complies with industry standards and regulatory requirements. The FDA expects that all companies manufacturing, packaging or holding dietary supplement products to adhere to 21 CFR 111, the Dietary Supplement cGMPs.
Part 2: This section of the training focuses on dietary product development and planning for regulatory compliance. The training provides a systematic plan for the development of new dietary supplements. It includes regulatory reviews, user requirements, and the necessary steps needed to ensure that an organization is successful when entering the market as a startup. In addition to looking at the regulatory requirements we will review financial considerations and the decision points in the process.
The target, what does the market want?
· User requirements for the consumer
· Physical form
· Regulatory requirements
· Financial considerations
· How much will the market pay?
· Cost of components?
· Preliminary ROI calculation
· Specification development
· Process design
· Engineering design
· Cost calculations
· Cost of Goods Sold
· Final ROI calculation
· Decision to begin production/sales
Who Should Attend?
• Regulatory Affairs
• Quality Control/Assurance
• Laboratory Operations
• Suppliers and Distributors
General Registration $800.00
December 13, 2023 - 1:00 P.M to 4:30 P.M
December 14, 2023 - 1:00 P.M to 4:30 P.M
Course Prerequisites: None
ISO 13485:2016 Overview and Country-Specific Medical Devices Regulations: Six-Course Bundle
Post-Market Surveillance and Vigilance Requirements for Manufacturers (EU 2017/745)
Deviation Investigations and CAPA