Entering the Dietary Supplement Market as a Start-up – Facility Design for GMP Compliance
About This Course
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.
Our experts will discuss facility design for GMP compliance, sources of contamination and how to prevent them.
Key Learning Objectives and Course Outline
Key topics covered on this dietary Supplement facility design training includes:
Facility Design
- Sources of contamination
- Distinct hygienic zones
- Site
- Building envelope
- Personnel and material flows
- Interior spatial design
- Building components and construction
- Utility systems
- Water management
- Room temperature and humidity
- Room air quality and flow
Equipment Design
- Cleanable to a microbiological level
- Made of compatible materials
- Accessible for inspection, maintenance, cleaning, and sanitation
- No product or liquid collection
- Hermetically sealed hollow areas
- No niches
- Sanitary operational performance
- Hygienic design of maintenance enclosures
- Hygienic compatibility with other plant systems
- Verified cleaning and sanitizing procedures
Types of Water
Types of Cleaning
- Clean-in-Place (CIP)
- Clean-Out-of-Place (COP)
- Manual
- Dry
- Flush
- None
Who Should Attend?
This dietary supplement facility design training is suitable for:
- Entrepreneurs
- Management
- Manufacturing
- Quality control/assurance
- Packaging
- Marketing
- Laboratory operations
- Auditing
- Suppliers and distributors
- Regulatory affairs
Instructors
Course instructors will be selected from the following:
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.