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Books by Markus Roemer
  | | Data Integrity in Pharmaceutical and Medical Devices Regulation Operations(1st Edition) Best Practices Guide to Electronic Records Compliance by Orlando Lopez, Markus Roemer Hardcover, 394 Pages, Published 2016 by Productivity Press ISBN-13: 978-1-4987-7324-9, ISBN: 1-4987-7324-9 "Data integrity is fundamental in a pharmaceutical and medical devices quality system. This book provides practical information to enable compliance with data integrity, while highlighting and efficiently integrating worldwide regulation into the subject. The ideas presented in this book are based on many years' experience in the US Department of Defense and regulated industries in various computer systems development, maintenance, and q ..." |
 | | EU Annex 11 Guide to Computer Validation Compliance for the Worldwide Health Agency GMP(1st Edition) by Orlando Lopez, Markus Roemer, Bernd Renger Hardcover, 379 Pages, Published 2015 by Crc Press ISBN-13: 978-1-4822-4362-8, ISBN: 1-4822-4362-8 "Good Manufacturing Practice (GMP) ensures medicinal products are produced consistently and controlled to the quality standards appropriate for their intended use and as required by product specifications or marketing authorization. Annex 11 details the European Medicines Agency (EMA) GMP requirements for computer systems. The purpose of Annex 11 is to provide the EMA healthcare industry with consistent criteria for effective implementat ..." |
 | | Computergestützte Systeme im GMP-Umfeld(1st Edition) Hardware und Software GMP-konform validieren und betreiben (GMP-Fachwissen) by Markus Roemer Hardcover, 146 Pages, Published 2017 by Maas & Peither Gmp ISBN-13: 978-3-95807-076-9, ISBN: 3-95807-076-0 |
 | | Elektronisches Datenmanagement im GMP-Umfeld GMP-konforme IT-Systeme in der Arzneimittelherstellung, Auszug aus dem GMP-BERATER by Dr. Ulf Fuchslueger, Markus Roemer, Thilo Gukelberger, Dr. Thomas Trantow Published 2017 ISBN-13: 978-3-95807-077-6, ISBN: 3-95807-077-9 |
 | | GMP-gerechte Dokumentation in der Pharmaindustrie(4th Edition) GMP-BERATER Paperback Band 1 by Ruven Brandes, Christian Gausepohl, Michael Hiob, Josef Künzle, Markus Roemer, Cornelia Wawretschek Paperback, 176 Pages, Published 2013 by Maas & Peither Gmp ISBN-13: 978-3-943267-67-9, ISBN: 3-943267-67-9 |
 | | Papierbasierte und elektronische Dokumentation im Pharmaunternehmen(1st Edition) Anforderungen an GMP-konforme Dokumentationssysteme : Auszug aus dem GMP-BERATER by Michael Dr. Hiob, Markus Dr. Limberger, Markus Roemer, Markus Prof. Dr. Veit, Cornelia Wawretschek Hardcover, 144 Pages, Published 2017 by Maas & Peither Gmp ISBN-13: 978-3-95807-069-1, ISBN: 3-95807-069-8 |
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Markus Roemer
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