Orlando Lopez
E-records Integrity SME, USA
Biography
Orlando Lopez works for the past twenty five years works in the areas of worldwide pharmaceutical compliance, Part 11 remediation, and EMA Annex 11 in the production and quality control systems relevant to the manufacture of medicinal products. He is a SME on electronic records integrity and worldwide regulations applicable to computer compliance. He had papers published by ISPE's Pharmaceutical Engineering, Pharmaceutical Technology and GXP Journal magazines. He is the author of five computer compliance books, including one on EU Annex 11. He is currently writing his 6th book about the best practices on e-records integrity. This book is to be published by CRC by 2016 Q3.
Abstract
Abstract : Trustworthy computer systems