Orlando Lopez

Orlando Lopez is a seasoned professional with global pharmaceutical and medical device computer systems compliance experience for companies such as J&J, Allergan, Lilly, Novartis, Pfizer, and Catalent. Orlando published "Data Integrity in Pharmaceutical and Medical Device Regulation Operations," a book about best practices in e-records integrity. https://www.routledge.com/Data-Integrity-in-Pharmaceutical-and-Medical-Devices-Regulation-Operations/Lopez/p/book/9781498773249. Orlando also possesses e-compliance experience within system quality and compliance of GxP regulations/guidelines (21 CFR Parts 211.68 and 11, EU Annex 11, MHRA, PIC/S, and data integrity), as well as detailed knowledge of the SLC, software and e-records QA, and infrastructure qualification. Orlando has vast experience with risk management practices, and provides expert knowledge of industry best practices such as GAMP5, ANSI standards (S-95, S-88), and ASTM (E2500).


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