저자 주요 이력
Orlando is a senior innovation professional providing scientific leadership and strategic vision to designing, implementing, and nurturing a national research agenda to accelerate translation of cutting-edge scientific and technical innovations to human use.
• Creating inclusive patient-centered innovation programs that guide preclinical developments to scalable commercialization and user adoption.
• Nurturing talent development, academic and industry innovators & entrepreneurs.
• Building global, inclusive, coalitions and active partnerships with leaders from academia, government and private
sectors to advance strategic goals and streamline new innovations to commercialization • Advancing technology incubation through portfolio of R&D programs and funding initiatives supporting new innovation in cutting-edge technologies • Leading contributions to professional working groups and industry standards development committees: NIH Data Science and Interagency Modeling and Analysis Group, DoD’s Working Group on Computational Modeling, IEEE 2933 Standard on Clinical IoT Interoperability with TIPPSS, IEEE Healthcare Blockchain and AI, DMV Chapter of Blockchain in Healthcare Today, ASME Biomedical Engineering Technical Committee, American Dental Association (ADA) Standards on Dental Products, American Council for Technology and Industry Advisory Council (ACT-IAC) Blockchain and AI Working Groups.
• Mentor, advisor, presenter, author, fluent in English & Spanish SPECIALTY AREAS
Leading the Translation of New Technologies: Lab-to-Human & Lab-to-Market Strategies - FDA Product Approval Process and Strategy - Pre-Seed Funding: Small Business and Academic Grants, Initiative Development - Leading Coalitions & Strategic Partnerships Operations & Strategic Planning:
- Program, Project & Product Management - Quality Systems & Consensus Standards - Risk Assessment
- Business Acumen & Tech Transfer
- Valuation and Due Diligence
R&D | Technology Innovation | FDA Strategy - Data Science, Blockchain AI ML
- Computational Modeling & Simulation - Preclinical and Clinical Performance Testing - Quality System Regulations | GMP'S | ISO's - Human Factors and Usability Engineering - Dental Materials and Biomaterials - Dental, Oral and Craniofacial Devices | Biosensors - Digital Dentistry & Health | Mobile App Devices | IoT | Robotics - Monitoring, Diagnostic and Treatment Devices - Implantables | Drug Delivery | Nanotechnology - Tissue Eng and Reg Medicine | Biofabrication - Medical Imaging Modalities & Technologies
내용 구성
3. Electronic Records Life Cycle
- Creation
- Access, Use, and Reuse
- Migration
- Transformation
- Physical Deletion
- E-Records and Computer System Life Cycles
4. Electronic Records Related Definitions
5. Electronic Records Handling : 21 CFR Part 211
6. Electronic Records Handling : EMA Annex 11
7. Relevant Worldwide GMP Regulations and Guidelines
8. Trustworthy Computer Systems
9. MHRA Guidance
10.Electronic Records Governance
11.Procedural Controls for Handling E-Records
12.Electronic Record Controls : Supporting Processes
13.Electronic Records Controls : Records Retatined by Computer Storage
14.Electronic Record Controls : During Processing
15.Electronic Record Controls : While in Transit
16.Electronic Records and Contrcact Manufacturers
17.Electronic Records and Cloud Computing
18.Self-Inspections
19.Electronic Records Remediation Project
Appendix 1 : Glossary of Terms
Appendix 2 : Abbreviations and/or Acronyms
Appendix 3 : Regulatory Cross Match
Appendix 4. MHRA GMP Data Integrity Definitions and Guidance for Industry March 2015
Appendix 5. Relevant Worldwide GCP and GLP Regulations and Guidelines
Appendix 6. Electronic Records Integrity in Non-Clinical Laboratories
Appendix 7. Electronic Records Integrity in Clinical Systems
Appendix 8. Electronic Records Integrity in Data Warehouse and Business Intelligence
Appendix 9. Checklist E-Records Integrity
Appendix 10. Bibliography
책소개
데이터 무결성은 제약 및 의료 기기 품질 시스템에서 기본적인 요소입니다. 이 책은 데이터 무결성을 준수하는 데 필요한 실용적인 정보를 제공하며, 동시에 전 세계 규제를 주제에 효과적으로 통합합니다.
이 책에 제시된 아이디어들은 다양한 컴퓨터 시스템의 개발, 유지, 품질 기능 등 규제 산업에서의 여러 해 동안의 경험을 바탕으로 합니다.
사례 연구뿐만 아니라, 효율성을 높이고 데이터 무결성 통제의 설계 및 테스트가 올바르게 이루어지도록 하는 실용적인 접근 방법이 제시됩니다.
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