Entering the Dietary Supplement Market as A Startup - Product development, Planning for Regulatory Compliance

Are you entering the nutritional supplement market as a startup? This instructor-led course focuses on the steps you need to take for product development and planning for regulatory compliance. This comprehensive training delivers extensive industry experience and real-world exercises with networking opportunities to ask questions and learn best practices from colleagues looking to enter the dietary supplement industry.

At the end of this course, you will know and understand:

• • 21 CFR 111 regulatory requirements for dietary supplement products to enter the industry
  • the financials required to develop, manufacturer and launch dietary supplements using cost calculations
  • How to determine and develop product user requirements for use throughout the development process

Physical Form

• Packaging
• Dosage
• Benefits (what health claims will be made)
• User requirements for us
• Projected volume
• Marketing costs

Regulatory Requirements

• Does this product contain a new dietary ingredient (NDI)?
• Health claims

Financial Considerations

• How much will the market pay?
• Can I make this product with existing equipment?
• Is the new product a copy of an existing one?

Cost of Components

• Fixed costs
• Product development cost
• Marketing costs

Preliminary ROI Calculation

• The decision to begin development

Specification Development

• Final product
• Components
• In-process
• Analytical method development
• Process design
• Engineering design
• Cost calculations
• Capital
• Marketing
• Cost of goods sold

Final ROI calculation

• The decision to commence production/sales
• Conclusion
• Resources

This dietary supplement product development training is suitable for:

• Entrepreneurs
• Management
• Manufacturing
• Quality control/assurance
• Packaging
• Marketing
• Laboratory operations
• Auditing
• Suppliers and distributors
• Regulatory affairs

Course tutors will be selected from the following:

Norman Howe - Norman Howe is an experienced quality consultant. Norman has taught a course in quality systems as adjunct faculty at the University of Michigan, Ann Arbor. He serves as an expert witness in FDA-regulated product quality cases.

Previously, Norman was the plant manager of a pharmaceutical plant with BASF and was responsible for manufacturing, quality assurance, engineering, maintenance, contract manufacturing and a small product development group.

Nicole Leitz - Nicole Leitz has more than 20 years of experience in the 21 CFR regulated industries. She has written and presented numerous training sessions on quality system elements and best cGMP practices to corporate clients and at national conventions. Nicole is also an experienced remediation consultant. She has advised, and written documentation such as SOPs and WIs and has completed root cause investigations, CAPAs and complaints for corporate clients.

Nicole has a Master of Science degree in organic chemistry from Bucknell University and a Bachelor of Science in ACS chemistry from Hope College.