Orlando Lopez
Data Integrity in Pharmaceutical and Medical Devices Regulation Operations
Best Practices Guide to Electronic Records Compliance
Orlando Lopez
Data Integrity in Pharmaceutical and Medical Devices Regulation Operations
Best Practices Guide to Electronic Records Compliance
- Broschiertes Buch
- Merkliste
- Auf die Merkliste
- Bewerten Bewerten
- Teilen
- Produkt teilen
- Produkterinnerung
- Produkterinnerung
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 regulated industries
Andere Kunden interessierten sich auch für
- Prashant NatarajanDemystifying Big Data and Machine Learning for Healthcare50,99 €
- Developing a Data Warehouse for the Healthcare Enterprise86,99 €
- Orlando LópezEnsuring the Integrity of Electronic Health Records74,99 €
- Rebecca Mendoza Saltiel BuschLeveraging Data in Healthcare93,99 €
- David HartzbandInformation Technology and Data in Healthcare50,99 €
- Donna GoestenkorsThe Executive Medical Services Professional50,99 €
- Roger KropfIt Governance in Hospitals and Health Systems104,99 €
-
-
-
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 regulated industries
Produktdetails
- Produktdetails
- Verlag: Taylor & Francis
- Seitenzahl: 396
- Erscheinungstermin: 12. Juli 2022
- Englisch
- Abmessung: 254mm x 178mm x 21mm
- Gewicht: 685g
- ISBN-13: 9781032339887
- ISBN-10: 1032339888
- Artikelnr.: 69899489
- Verlag: Taylor & Francis
- Seitenzahl: 396
- Erscheinungstermin: 12. Juli 2022
- Englisch
- Abmessung: 254mm x 178mm x 21mm
- Gewicht: 685g
- ISBN-13: 9781032339887
- ISBN-10: 1032339888
- Artikelnr.: 69899489
Orlando Lopez E-records Integrity SME Durham North Carolina USA Orlando Lopez has significant understanding and experience with worldwide regulatory authorities regarding CSV, e-records integrity, and related requirements/guidelines related to Production Manufacturing Systems, IT Systems, Analytics, and Business Intelligence. He has knowledge and experience in the development of governance and SLC deliverables. Wrote and deployed CSV methodology to computer infrastructure J&J worldwide. Several times he had re-engineered the computer validation methodology to regulated companies. Orlando Lopez has experience with direct participation in FDA agency remedial action plans, regulatory inspections, response activities, and consent decree remediation related verifications. He is published in the Encyclopedia of Pharmaceutical Science and Technology, 4th Edition - Chapter 56 Computer Systems Validation (Taylor & Francis Group, LLC) and had written 25+ publications, including 9 computer compliance related books - amazon.com/author/orlandolopez/ Familiar with gap assessment, remediation planning and remediation execution activities.
Preface. Introduction. Inspection Trends. Electronic Records Life Cycle.
MHRA Definitions. Electronic Records Governance. Relevant Electronic
Records Management Procedural Controls. Electronic Records Controls -
Supporting Processes. Electronic Records Controls - In Storage. Electronic
Records Controls - During Processing. Electronic Records Controls - While
in Transit. Trustworthy Computer Systems. Electronic Records and Service
Providers. Relevant Worldwide GMP Regulations and Guidelines. MHRA
Guidance. Electronic Records Management - 21 CFR Part 211. Electronic
Records Management - EMA Annex 11. Self Inspection. Summary. Appendices:
Glossary of Terms. Abbreviations and Acronyms. Regulatory Cross Match. MHRA
GMP Data Integrity Definitions and Guidance for Industry March 2015.
Relevant Worldwide GCP and GLP Regulations and Guidelines. Electronic
Records Integrity in Non-Clinical Laboratories. Electronic Records
Integrity in Clinical Systems. Electronic Integrity in a Data Warehouse and
Business Intelligence.
MHRA Definitions. Electronic Records Governance. Relevant Electronic
Records Management Procedural Controls. Electronic Records Controls -
Supporting Processes. Electronic Records Controls - In Storage. Electronic
Records Controls - During Processing. Electronic Records Controls - While
in Transit. Trustworthy Computer Systems. Electronic Records and Service
Providers. Relevant Worldwide GMP Regulations and Guidelines. MHRA
Guidance. Electronic Records Management - 21 CFR Part 211. Electronic
Records Management - EMA Annex 11. Self Inspection. Summary. Appendices:
Glossary of Terms. Abbreviations and Acronyms. Regulatory Cross Match. MHRA
GMP Data Integrity Definitions and Guidance for Industry March 2015.
Relevant Worldwide GCP and GLP Regulations and Guidelines. Electronic
Records Integrity in Non-Clinical Laboratories. Electronic Records
Integrity in Clinical Systems. Electronic Integrity in a Data Warehouse and
Business Intelligence.
Preface. Introduction. Inspection Trends. Electronic Records Life Cycle.
MHRA Definitions. Electronic Records Governance. Relevant Electronic
Records Management Procedural Controls. Electronic Records Controls -
Supporting Processes. Electronic Records Controls - In Storage. Electronic
Records Controls - During Processing. Electronic Records Controls - While
in Transit. Trustworthy Computer Systems. Electronic Records and Service
Providers. Relevant Worldwide GMP Regulations and Guidelines. MHRA
Guidance. Electronic Records Management - 21 CFR Part 211. Electronic
Records Management - EMA Annex 11. Self Inspection. Summary. Appendices:
Glossary of Terms. Abbreviations and Acronyms. Regulatory Cross Match. MHRA
GMP Data Integrity Definitions and Guidance for Industry March 2015.
Relevant Worldwide GCP and GLP Regulations and Guidelines. Electronic
Records Integrity in Non-Clinical Laboratories. Electronic Records
Integrity in Clinical Systems. Electronic Integrity in a Data Warehouse and
Business Intelligence.
MHRA Definitions. Electronic Records Governance. Relevant Electronic
Records Management Procedural Controls. Electronic Records Controls -
Supporting Processes. Electronic Records Controls - In Storage. Electronic
Records Controls - During Processing. Electronic Records Controls - While
in Transit. Trustworthy Computer Systems. Electronic Records and Service
Providers. Relevant Worldwide GMP Regulations and Guidelines. MHRA
Guidance. Electronic Records Management - 21 CFR Part 211. Electronic
Records Management - EMA Annex 11. Self Inspection. Summary. Appendices:
Glossary of Terms. Abbreviations and Acronyms. Regulatory Cross Match. MHRA
GMP Data Integrity Definitions and Guidance for Industry March 2015.
Relevant Worldwide GCP and GLP Regulations and Guidelines. Electronic
Records Integrity in Non-Clinical Laboratories. Electronic Records
Integrity in Clinical Systems. Electronic Integrity in a Data Warehouse and
Business Intelligence.