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Essential Elements for a GMP Analytical Chemistry Department.
Essential Elements for a GMP Analytical Chemistry Department is a systematic approach to understanding the essential elements required for a successful GMP Analytical Department to function as an efficient and effective organization. It describes in detail a department structure which allows for the...
| Clasificación: | Libro Electrónico |
|---|---|
| Autor principal: | |
| Formato: | Electrónico eBook |
| Idioma: | Inglés |
| Publicado: |
Dordrecht :
Springer,
2013.
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| Temas: | |
| Acceso en línea: | Texto completo |
MARC
| LEADER | 00000cam a2200000Mu 4500 | ||
|---|---|---|---|
| 001 | EBOOKCENTRAL_ocn854976001 | ||
| 003 | OCoLC | ||
| 005 | 20240329122006.0 | ||
| 006 | m o d | ||
| 007 | cr |n||||||||| | ||
| 008 | 130803s2013 ne o 000 0 eng d | ||
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| 020 | |a 9781461476429 | ||
| 020 | |a 1461476429 | ||
| 029 | 1 | |a AU@ |b 000055909446 | |
| 035 | |a (OCoLC)854976001 | ||
| 050 | 4 | |a RS189 | |
| 082 | 0 | 4 | |a 615.1901 |
| 049 | |a UAMI | ||
| 100 | 1 | |a Catalano, Thomas. | |
| 245 | 1 | 0 | |a Essential Elements for a GMP Analytical Chemistry Department. |
| 260 | |a Dordrecht : |b Springer, |c 2013. | ||
| 300 | |a 1 online resource (202 pages) | ||
| 336 | |a text |b txt |2 rdacontent | ||
| 337 | |a computer |b c |2 rdamedia | ||
| 338 | |a online resource |b cr |2 rdacarrier | ||
| 505 | 0 | |a 312574_1_En_BookFrontmatter_OnlinePDF; Preface; Contents; Abbreviations; 1 Introduction; 2 Organization; Abstract; 2.1 ... Department StructureDepartment Structure; 2.2 ... Project TeamsProject Teams; 2.2.1 Project Team Development and Management; 2.2.2 Risk EvaluationRisk Evaluation; 2.2.3 Project Team DynamicsProject Team Dynamics; 2.2.3.1 The Teams Leader Role is as Follows; 2.2.3.2 The Team Member Role is as Follows; 2.2.3.3 Brainstorming ProcessBrainstorming Process; 2.2.3.4 Rounds of ReasoningRounds of Reasoning; 2.2.3.5 Clarifying Question. | |
| 505 | 8 | |a 2.2.3.6 Highest Level of AuthorityHighest level of Authority2.2.3.7 Modes of DecisionModes of Decision Making; 2.2.3.8 Use of ConsensusUse of Consensus; 2.2.3.9 ScribeScribe; 2.2.3.10 FacilitationFacilitation; 2.2.3.11 GovernanceGovernance [2]; 2.3 ... Responsibilities; 2.4 ... Interactions [3]; 2.5 ... Operating Guidance'sOperating Guidance's; 2.5.1 SOP's and Guidelines; 2.5.1.1 Laboratory OperationsLaboratory Operations; 2.5.1.2 Department PoliciesDepartment Policies; 2.5.1.3 Management ControlManagement Control; 2.5.2 Regulatory Guidance's; References; 3 Processes; Abstract. | |
| 505 | 8 | |a 3.1 ... Safety ProcessSafety Process3.2 ... Technology ProcessesTechnology Processes; 3.2.1 Systematic Approach to HPLC Method DevelopmentHPLC Method Development [1, 2]; 3.2.2 Dissolution Method DevelopmentDissolution Method Development; 3.2.3 Systematic Approach to Method ValidationMethod Validation; 3.2.4 Analytical Technology TransferTechnology Transfer Process; 3.3 ... Departmental Processes; 3.3.1 Specification DevelopmentSpecification Development Process; 3.3.2 Stability ManagementStability Management Process [9]; 3.3.3 Reference Standard CertificationReference Standard Certification Process [11]. | |
| 505 | 8 | |a 3.3.4 TrainingTraining [12]References; 4 Statistical Concepts for the Analytical Chemist; Abstract; 4.1 ... Distribution; 4.1.1 Student's t DistributionStudent's t distribution; 4.1.2 Chi-Squared DistributionChi-squared distribution {{\usertwo (x^{2})}}; 4.1.3 The F DistributionF distribution; 4.2 ... Significance TestingSignificance Testing; 4.2.1 Arithmetic MeanArithmetic Mean; 4.2.2 MedianMedian; 4.2.3 Standard DeviationStandard Deviation; 4.2.4 Standard Error of the MeanStandard Error of the Mean; 4.2.5 Relative Standard DeviationRelative Standard Deviation (Coefficient of Variation). | |
| 505 | 8 | |a 4.2.6 Hypotheses4.2.7 Significant Testing [3]; 4.3 ... Confidence IntervalsConfidence Intervals for the Mean [4]; 4.4 ... OutlierOutliers in Analytical Data [4]; 4.5 ... Regression Analysis [5]; 4.6 ... Design of Experiments [6 -- 8]; 4.7 ... Required Sample Replicates [4]Sample Replicates; 4.8 ... Method Performance; 4.8.1 Method PrecisionMethod Precision [4]; 4.8.2 AccuracyAccuracy; 4.8.3 Linearity [1, 4]; 4.8.4 Limit of Detection (LOD)Limit of detection (LOD) [4]; 4.8.5 Limit of Quantitation (LOQ)Limit of Quantitation (LOQ); 4.8.6 RuggednessRuggedness [8, 9]. | |
| 500 | |a 4.9 ... Measurement UncertaintyMeasurement Uncertainty [4, 10]. | ||
| 520 | |a Essential Elements for a GMP Analytical Chemistry Department is a systematic approach to understanding the essential elements required for a successful GMP Analytical Department to function as an efficient and effective organization. It describes in detail a department structure which allows for the necessary processes to become available to all its personnel in a way where there is a free flow of information and interaction. The environment and culture created by this approach encourages and rewards the sharing of ideas, skills, and abilities among department personnel. The essential element. | ||
| 588 | 0 | |a Print version record. | |
| 590 | |a ProQuest Ebook Central |b Ebook Central Academic Complete | ||
| 650 | 0 | |a Medicine. | |
| 650 | 0 | |a Pharmaceutical biotechnology. | |
| 650 | 2 | |a Medicine | |
| 650 | 6 | |a Médecine. | |
| 650 | 6 | |a Biotechnologie pharmaceutique. | |
| 650 | 7 | |a medicines (material) |2 aat | |
| 650 | 7 | |a medicine (discipline) |2 aat | |
| 650 | 7 | |a Medicine |2 fast | |
| 650 | 7 | |a Pharmaceutical biotechnology |2 fast | |
| 758 | |i has work: |a Essential elements for a GMP analytical chemistry department (Text) |1 https://id.oclc.org/worldcat/entity/E39PCGyFrpCb4V34XypdR3pGjK |4 https://id.oclc.org/worldcat/ontology/hasWork | ||
| 776 | 0 | 8 | |i Print version: |a Catalano, Thomas. |t Essential Elements for a GMP Analytical Chemistry Department. |d Dordrecht : Springer, ©2013 |z 9781461476412 |
| 856 | 4 | 0 | |u https://ebookcentral.uam.elogim.com/lib/uam-ebooks/detail.action?docID=1317545 |z Texto completo |
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