Batch Control and Inventory Management for Dietary Supplements

Why Should You Attend:

In the manufacture of dietary supplements, the FDA, under 21 CFR, Part 111, requires that Master Manufacturing and Batch Production Records be created and maintained. Proper inventory management of raw materials and components has a direct impact on the development and maintenance of master and batch production records.

This webinar explains the proper way to create FDA required Master Manufacturing and Batch Production records. FDA 21CFR Part 111 requires that Master Manufacturing and Batch Production records be created. This webinar will define what each of these requirements is and how to apply them in a production environment to the satisfaction of the FDA. The webinar will also discuss how inventory control techniques have an impact on the process of creating and managing these records.

Areas Covered in the Webinar:

This webinar will cover the following;

• Define what a Master Manufacturing Record is
• Define what a Batch Production Record is
• Explain when Master Manufacturing Records need to be created
• Explain how to manage Master Manufacturing Records
• Explain how to manage Batch Productions Records
• Discuss inventory management processes for making the development and management of Master and Batch records efficient and easy
• Show examples of Master Manufacturing and Batch Production records
• Discuss electronic records management versus paper driven systems
• Show examples of electronic and paper driven systems

Who Will Benefit:

This webinar will benefit those who have production and quality control responsibilities in a Dietary Supplements manufacturing plant.

• 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.

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