Raw Material Identification, Specifications and Vendor Qualifications
Instructor:
Chris Stefanadis
Product ID: 705596
- Duration: 60 Min
Why Should You Attend:
FDA CFR Part 111 requires identify testing of dietary components that are to be used to manufacture dietary supplements. Identify testing is only part of the FDA requirement. Specifications must also be properly set up, documented and used correctly. When purchasing dietary components for use in dietary supplements the FDA has requirements for vendor qualification that tie into the specification requirements.
This webinar will define identity testing. It will also show how to set up proper specifications and how-to qualify the vendors that the material is purchased from.
Areas Covered in the Webinar:
- Define identity testing versus specification requirements
- Define which dietary components need to undergo identity testing and how that can be done.
- Present identity testing examples
- Discuss in house testing versus use of external labs
- Discuss how to set up and use component specifications
- Discuss testing requirements for component specifications
- Discuss how to qualify dietary component vendors and what it means for a vendor to be qualified
Who Will Benefit:
- QA Managers
- Lab Managers
- Lab Technicians
- Purchasing Managers
- Receiving clerks
- Production Operators
- Plant Managers
- Company Owners
Chris Stefanadis
Regulatory Affairs Professional, Centric Consulting
Chris Stefanadis has over 20 years of Quality Management systems and process improvement experience and is Six Sigma Black Belt certified.
His Quality Management Systems experience includes the development, implementation and management in manufacturing plants and service organizations of ISO 9001, ISO 13485, TS 16949, ISO 14001, GMP, FDA 21 CFR Part 111 and Part 820.
A strong manufacturing background with Nutraceuticals, Medical Devices, Plastic Extrusion & Compression Molding, Acrylic Latex and Chemical Manufacturing has also given him experience with Lean Manufacturing and Process Improvements.
Topic Background:
Improper identification of dietary components exposes nutraceutical manufacturers to unnecessary risk. Identity testing of dietary components is required by the FDA as per CFR part 111.
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