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:
- Sources of contamination
- Distinct hygienic zones
- 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
- 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)
Who Should Attend?
This dietary supplement facility design training is suitable for:
- Quality control/assurance
- Laboratory operations
- Suppliers and distributors
- Regulatory affairs
Course instructors 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.