Orlando Lopez

Orlando, E-records Integrity SME, has worked for the past twenty-five years in the areas of worldwide pharmaceutical and medical devices computer compliance in the production and quality control systems relevant to the manufacture of products. He has regulatory experience with direct participation in US FDA agency remedial action plans, regulatory inspections, response activities, and consent decree remediation related verifications. Orlando has over forty publications, including eight (8) computer compliance related books, amazon.com/author/orlandolopez. The most recent titles are EU Annex 11 Guide to Computer Validation Compliance for the Worldwide Health Agency GMP, CRC Press, http://www.crcpress.com/product/isbn/9781482243628 and Best Practices Guide to Electronic Records Compliance, CRC Press, https://www.routledge.com/Data-Integrity-in-Pharmaceutical-and-Medical-Devices-Regulation-Operations/Lopez/p/book/9781498773249

He can be contacted via email.


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