On a personal note. On Wednesday evening, April 16, I'll be speaking at the joint dinner meeting of APICS Orange County and ASQ on the subject of "Enterprise Systems in an FDA-Regulated Environment." Here's the abstract.

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Manufacturing firms in all industries use computer systems, such as ERP, Product Data Management, Supply Chain Management, and Quality Management to meet requirements for managing resources and ensuring product quality. But companies in regulated industries, such as the life sciences (pharmaceuticals, biotech, medical devices, etc.), must comply with additional governmental requirements to ensure the integrity and trustworthiness of such systems.

In this fast-moving presentation, Frank Scavo will outline how FDA regulations affect the use of computer systems in the design, manufacture, and distribution of medical devices, drugs, and biologic products. Specifically:

1. How FDA regulations for Good Manufacturing Practices (GMP) and Quality Systems affect use of computer applications such as such as ERP, Supply Chain Management, and Product Data Management



2. What FDA expects you to do to validate a computer system "for its intended use"



3. New FDA draft guidance regarding use of electronic records and electronic signatures (21 CFR Part 11)

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Reservations are due by noon, April 14, and may be made by calling APICS Orange County at (949) 863-7625. Or, contact me if you would like more information.