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1

Draft Guideline on Validation of Analytical Procedures for Pharmaceuticals (Fda Harmonisation). Interpharm Pr, 1994.

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2

Haider, Syed Imtiaz. Pharmaceutical Master Validation Plan: The Ultimate Guide to FDA, GMP, and GLP Compliance. Informa Healthcare, 2001.

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3

Stokes, David. Testing Computers Systems for FDA/MHRA Compliance (Computer Systems Validation Life Cycle Activities). Informa Healthcare, 2003.

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4

Pharmaceutical Computer Validation Introduction Manual and CD, GMP (Good Manufacturing Practices) Training Introduction To Meet FDA Regulations in the ... on Computer System Validation and Part 11. UniversityOfHealthCare, 2003.

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5

Farb, Daniel. Pharmaceutical Computer Validation Introduction 5 Users: GMP (Good Manufacturing Practices) Training Introduction to Meet FDA Regulations in the Use of ... on Computer System Validation and Part 11. UniversityOfHealthCare, 2005.

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6

Part 11 and Computer Validation Manual and CD, The FDA Regulations on Part 11, Electronic Records and Electronic Signatures, For Pharmaceutical, Medical ... Emphasis on Computer System Validation a. UniversityOfHealthCare, 2003.

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7

Guide to Inspections of Oral Solid Dosage Forms-Pre/Post Approval Issues for Development and Validation (Fda Inspection Guidelines). Interpharm Pr, 1994.

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8

PIAE EUROPE 2021. VDI Verlag, 2021. http://dx.doi.org/10.51202/9783181023853.

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Contents Structural components/Strukturbauteile Development of an energy-absorbing structural element made of polyamide integrated in the plastic front-end carrier of the new Mercedes S-Class ..... 1 Entwicklung eines energieabsorbierenden Strukturelements aus Polyamid integriert im Kunststoff-Frontendträger der neuen Mercedes S-Klasse ..... 5 BAGS: Highly-integrated front-end module carrier ..... 9 BAGS: Hochintegrierter Front End Modulträger ..... 19 Surfaces/Oberflächen Lightweight plastic construction with visible surface as examplified by the Volkswagen ID 3 tailgate ..... 29 Kunststoffleichtbau mit Sichtoberfläche am Beispiel der Heckklappe Volkswagen ID3 ..... 39 Breakthrough in producing soft and sustainable interior surfaces by injection moulding of TPE ..... 49 Simulation The all-new MAN high-roof cab – epoxy sandwich RTM – simulated using FEM and crashed under real conditions ..... 61 Epoxid-Sandwich-RTM – FEM gerechnet und real gecrasht ..... 75 Development and validation of a simulation methodology for the prediction of surface defects for plastic components with metallic effect pig...
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9

Celik, I. Experimental and Computational Aspects of Validation of Multiphase Flow Cfd Codes: Presented at the 1994 Asme Fluids Engineering Division Summer Meeti (Fed). American Society of Mechanical Engineers, 1994.

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10

ELIV 2019. VDI Verlag, 2019. http://dx.doi.org/10.51202/9783181023570.

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Der Bericht ist ausschließlich als PDF-Dokument erschienen! Content Foreword 1 ADAS Seeing With Sound – Next-level 3D ultrasonic sensors based on echolocation 5 N. Knappstein, Toposens, Munich Ensuring the reliability, availability and safety of fully automated and autonomous transport systems through modern system architectures 11 J. Heinrich, A. Braasch, Institut für Qualitäts- und Zuverlässigkeitsmanagement GmbH, Wuppertal; F. Plinke, Institut für Qualitäts- und Zuverlässigkeitsmanagement GmbH, Hamburg ADAS/AD Systems: Efficient Testing & Validation – From data acquisition to data analytics 21 M. Kremer, M. Kreutz, M. Luxen, S. Christiaens, FEV Europe GmbH, Aachen Problems and solution spaces for driver-initiated handover from automatic to manual driving mode 31 J. Klesing, Nexteer Automotive, Auburn Hills, USA; S. Safour, Nexteer Automotive, Paris, France UX User-centred development of a display concept for fully automated driving – A methodical approach 45 L. Gaue...
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11

Gutierrez, Genaro J., und Divya Chirumamilla. Cervical Spinal Stenosis. Herausgegeben von Mehul J. Desai. Oxford University Press, 2018. http://dx.doi.org/10.1093/med/9780199350940.003.0006.

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Cervical spinal stenosis is the narrowing of the spinal canal. Degenerative cervical spinal stenosis can occur as a result of disc degeneration, osteophyte formation, and hypertrophy of spinal canal ligaments. Diagnosis is primarily made with clinical history and examination in order to assess for classic myelopathic signs (motor weakness, hyperreflexia, and other specific tests). Radiologic imaging is used to validation the diagnosis and to determine the extent of stenosis. Magnetic resonance imaging is the most useful and noninvasive modality. Cervical spinal stenosis without myelopathy can be managed nonsurgically with strengthening, physical therapy, traction, orthosis, and pain management (cervical epidural steroid injections and selective nerve root blocks). Cervical spondylolisthesis has received insufficient attention in comparison to spondylolisthesis of the lumbar spine. It is primarily considered a surgical condition, yet few publications have been dedicated to the topic.
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12

Farb, Daniel. Pharmaceutical Computer Validation Introduction Library Edition: Gmp (Good Manufacturing Practices) Training Introduction to Meet Fda Regulations in the ... in Pharmaceutical, Medical Device, Food, and. University Of Health Care, 2004.

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13

Farb, Daniel. Part 11 and Computer Validation Library Edition: The FDA Regulations on Part 11, Electronic Records and Electronic Signatures, for Pharmaceutical, Medical Device, Food, and Cosmetics Manufacturing. University Of Health Care, 2004.

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14

Gordon, Bruce, und Daniel Farb. GMP Training Package Manual and CD, The FDA Regulations on Part 11, Electronic Records and Electronic Signatures, For Pharmaceutical, Medical Device, Food, ... System Validation and Part 11, Covering FD. UniversityOfHealthCare, 2003.

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15

Markwica, Robin. The Cuban Missile Crisis, 1962. Oxford University Press, 2018. http://dx.doi.org/10.1093/oso/9780198794349.003.0004.

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Chapter 4 examines Nikita Khrushchev’s decision-making in the Cuban missile crisis. It posits that the logic of affect offers a more comprehensive explanation of the Soviet prime minister’s choice behavior. Specifically, the model shows that his defiance of John F. Kennedy’s demand to remove the missiles from Cuba during the first two days of the crisis was shaped by his sense of humiliation and anger at what he saw as the American president’s refusal to recognize him as the leader of a co-equal power. In the last four days of the crisis, however, the decline of Khrushchev’s anger and humiliation and a growing fear of nuclear war shaped his preference for accepting Kennedy’s terms. That Khrushchev interpreted a message from Washington at the height of the crisis to mean that Kennedy was finally validating his equal status helped him to protect his self-esteem as he decided to withdraw the missiles.
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